EFFICACY

Overall Survival: 5-year Post-hoc Analysis

In unresectable Stage III NSCLC following cCRT

IMFINZI demonstrated consistent overall survival in 2-year and 5-year analyses1-3

2-YEAR PRIMARY OVERALL SURVIVAL ANALYSIS
(25.2 MONTHS MEDIAN FOLLOW-UP)1*:

NR

mOS with the PACIFIC Regimen

VS icon

28.7

months mOS with placebo following cCRT

HR=0.68 (95% CI, 0.53-0.87; P=0.0025)

IMFINZI continued its record of unprecedented survival with 43% of patients alive at the 5-year landmark3,4†

5-YEAR OVERALL SURVIVAL UPDATE3

Chart on 5-Year IMFINZI Overall Survival UpdateChart on 5-Year IMFINZI Overall Survival Update

The post-hoc 5-year OS analysis was conducted at ~5 years after the last patient was randomized, and was not powered to show statistical significance.3

*The primary 2-year OS analysis was conducted after 299 deaths for 42% maturity (61% of targeted events) with a median follow-up of 25.2 months. Reduction in the risk of death vs placebo was 32% (95% CI, 0.53-0.87) with a log-rank test stratified by sex, age, and smoking history. Median OS was NR with IMFINZI (95% CI, 34.7-NR) vs 28.7 months with placebo (95% CI, 22.9-NR).1,2

†Median OS was 47.5 months with IMFINZI (95% CI, 38.1-52.9) vs 29.1 months with placebo (95% CI, 22.1-35.1). Reduction in the risk of death vs placebo was 28% (HR=0.72; 95% CI, 0.59-0.89) with a log-rank test stratified by sex, age, and smoking history. OS rates with IMFINZI vs placebo were: 83% (95% CI, 79.4-86.2) vs 75% (95% CI, 68.5-79.7) at 12 months, 66% (95% CI, 61.8-70.4) vs 55% (95% CI, 48.6-61.4) at 24 months, 57% (95% CI, 52.0-61.1) vs 44% (95% CI, 37.1-49.9) at 36 months, 50% (95% CI, 45.0-54.2) vs 36% (95% CI, 30.1-42.6) at 48 months, and 43% (95% CI, 38.2-47.4) vs 33% (95% CI, 27.3-39.6) at 60 months.3

cCRT=concurrent chemoradiotherapy; CI=confidence interval; HR=hazard ratio; mOS=median overall survival; NR=not reached; NSCLC=non-small cell lung cancer; OS=overall survival.

Progression-free Survival: 5-year Post-hoc Analysis

In unresectable Stage III NSCLC following cCRT

IMFINZI demonstrated consistent results in median PFS at 1-year and 5-year analyses1,3,4

1-YEAR PRIMARY PFS ANALYSIS
(14.5 MONTHS MEDIAN FOLLOW-UP)1,4*:

16.8

months mPFS with the PACIFIC Regimen

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5.6

months mPFS with placebo following cCRT

HR=0.52 (95% CI, 0.42-0.65; P<0.0001)

One-third of patients were alive and progression free at 5 years with IMFINZI3†

5-YEAR PROGRESSION-FREE SURVIVAL UPDATE3

Chart on 5-Year IMFINZI Progression-Free Survival UpdateChart on 5-Year IMFINZI Progression-Free Survival Update

The post-hoc 5-year PFS analysis was conducted at ~5 years after the last patient was randomized, and was not powered to show statistical significance.3

In the 5-year post-hoc analysis, IMFINZI demonstrated 36.5 months (95% CI, 28.1-45.2) median TTDM and placebo 17.7 months (95% CI, 12.7-22.1) median TTDM (HR=0.59; 95% CI, 0.47-0.74)3‡

  • The incidence of new lesions in the ITT population occurred for IMFINZI and placebo in any site (24% and 33%), lung (13% and 18%), lymph nodes (7% and 12%), brain (7% and 12%), liver (2% and 3%), bone (2% and 3%), adrenal (1% and 2%), and other (2% and 2%). This analysis was not powered to show statistical significance3§

*Measured based on RECIST v1.1 criteria by BICR. The primary PFS analysis was conducted after 371 events (81% of targeted 458 events) with a median follow-up of 14.5 months. Reduction in risk of progression or death vs placebo was 48% (HR=0.52; 95% CI, 0.42-0.65) with a log-rank test stratified by sex, age, and smoking history. Median PFS was 16.8 months with IMFINZI (95% CI, 13.0-18.1) vs 5.6 months with placebo (95% CI, 4.6-7.8).1,3,4

†Measured based on RECIST v1.1 criteria by BICR. Reduction in the risk of progression or death vs placebo was 45% (HR=0.55; 95% CI, 0.45-0.68) with a log-rank test stratified by sex, age, and smoking history. PFS rates with IMFINZI vs placebo were: 56% (95% CI, 51.0-60.2) vs 35% (95% CI, 28.3-40.8) at 12 months, 45% (95% CI, 40.1-49.8) vs 25% (95% CI, 19.3-31.2) at 24 months, 40% (95% CI, 34.7-44.7) vs 21% (95% CI, 15.3-26.9) at 36 months, 35% (95% CI, 29.9-40.1) vs 20% (95% CI, 14.4-26.1) at 48 months, and 33% (95% CI, 28.0-38.2) vs 19% (95% CI, 13.6-25.2) at 60 months.3

‡TTDM was measured at the February 13, 2017 and March 22, 2018 DCOs, and is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis; distant metastasis is defined as any new lesion that is outside of the radiation field using BICR, according to RECIST v1.1 or proven by biopsy.3

§New lesions were assessed by RECIST v1.1 criteria by BICR and measured during the primary 2-year OS analysis, and the presence of 1 or more new lesions was assessed as progression. A lesion identified at a follow-up assessment in an anatomical location that was not scanned at baseline was considered a new lesion. Patients may have had more than 1 new lesion site. “Other” includes lesions in the biliary tract, chest wall, heart, ovary, pancreas, pericardium, retroperitoneum, skin, spleen, uterus, and other (unspecified).2,3

BICR=blinded independent central review; cCRT=concurrent chemoradiotherapy; CI=confidence interval; DCOs=data cutoffs; HR=hazard ratio; ITT=intent to treat; mPFS=median progression-free survival; NSCLC=non-small cell lung cancer; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors; TTDM=time to death or distant metastasis.

Hear what experts say about the 5-year data

Duration of Therapy–based Post-hoc Analysis

In unresectable Stage III NSCLC following cCRT

66% of patients who completed treatment* with IMFINZI were alive at 5 years5

OVERALL SURVIVAL IN PATIENTS WHO COMPLETED IMFINZI (n=190)†

Overall Survival in Patients Who Completed IMFINZI (n=190)Overall Survival in Patients Who Completed IMFINZI (n=190)

This post-hoc analysis was conducted 5 years after the last patient was randomized and was not powered to show statistical significance2,4,5

  • Completion defined as receiving ≥20 doses and at least 48 weeks of IMFINZI Q2W5
  • Patients who completed IMFINZI received a median of 25 doses of IMFINZI Q2W (50 weeks of IMFINZI treatment)5
  • In the ITT population, patients received a median of 20 doses of IMFINZI Q2W (40 weeks of treatment)4,5
  • Overall survival was measured from randomization5

66% of patients who completed treatment* with IMFINZI were alive at 5 years5

  • The 5-year PFS rate from randomization for patients who completed treatment with IMFINZI (n=190) was 43.4%5

Baseline characteristics were consistent between the IMFINZI ITT population and patients who completed IMFINZI3,5

IMFINZI PATIENTS

Baseline characteristics Completed treatment*
n=190		 ITT‡
n=476
Age Median (min, max) 63.0 (36, 83) 64.0 (31, 84)
Gender Male 71% 70%
WHO performance status 0 54% 49%
  1 46% 50%
Histology Squamous 40% 47%
  Nonsquamous 60% 53%
Staging by AJCC 7th edition§ IIIA 52% 53%
  IIIB 46% 45%
Best response to previous chemoradiotherapy CR 3% 2%
  PR 53% 49%
  SD 42% 47%
EGFR or ALK aberration statusII Negative 71% 66%
  Positive 5% 6%
  Unknown 24% 27%
 

*Completers defined as patients who received 20 to 26 doses once every 2 weeks and had no investigator-assessed disease progression before the end of therapy.5

†Post-hoc OS analysis measured from randomization to IMFINZI for patients whose treatment duration was ≥48 weeks and received ≥20 doses of IMFINZI and who did not progress while on therapy.5

‡~5 years after the last patient was randomized.2,4,5

§According to the AJCC Cancer Staging Manual, 8th edition of the TNM classification for lung cancer derived from databases for the International Association for the Study of Lung Cancer; the study included patients who are now classified as Stage IIIC.2,4,6,7

||Assessment of archived tumor samples obtained before cCRT.4

AJCC=American Joint Committee on Cancer; ALK=anaplastic lymphoma kinase; cCRT=concurrent chemoradiotherapy; CR=complete response; EGFR=epidermal growth factor receptor; ITT=intent to treat; NSCLC=non-small cell lung cancer; OS=overall survival; PFS=progression-free survival; PR=partial response; Q2W=every 2 weeks; SD=stable disease; TNM=tumor, node, metastasis; WHO=World Health Organization.

Clinical Guidelines

NCCN Category 1 recommendation for durvalumab (IMFINZI®) in unresectable Stage III NSCLC following cCRT8*†

NCCN Recommendation for IMFINZI in Unresectable Stage III NSCLC Following CRT NCCN Recommendation for IMFINZI in Unresectable Stage III NSCLC Following CRT

NCCN CATEGORY 1

Durvalumab (IMFINZI®) is the only NCCN Category 1 post-cCRT consolidation immunotherapy option for unresectable Stage III NSCLC with either a Q2W or Q4W dosing option8*†

  • Patients with a body weight of <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks1
  • IMFINZI is supplied as single-use vials that contain either 120 mg/2.4 mL or 500 mg/10 mL1
  • There are no anticipated clinically meaningful differences in efficacy and safety between Q2W and Q4W dosing with IMFINZI1‡

*Durvalumab (IMFINZI®) is recommended (Category 1) as a consolidation immunotherapy option for patients with unresectable Stage III NSCLC and performance status 0 to 1 and no disease progression after definitive concurrent CRT (except tumors that are positive for EGFR exon 19 deletion or exon 21 L858R mutations).8 Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2025. © 2025 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available.

†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

‡Based on the modeling of pharmacokinetic data and exposure relationships for safety in patients weighing >30 kg with NSCLC. The steady state AUC is 6% higher, the Ctrough is 19% lower, and Cmax is 55% higher in those who received 1500 mg Q4W compared with those who received 10 mg/kg Q2W.1

ALK=anaplastic lymphoma kinase; AUC=area under the curve; cCRT=concurrent chemoradiotherapy; CRT=chemoradiotherapy; CT=computed tomography; EGFR=epidermal growth factor receptor; FDG=fluorodeoxyglucose; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network® (NCCN®); NSCLC=non-small cell lung cancer; PD-L1=programmed death-ligand 1; PET=positron emission tomography; PFTs=pulmonary function tests; Q2W=every 2 weeks; Q4W=every 4 weeks.

The PACIFIC Regimen

Refer all your patients with unresectable Stage III NSCLC to a radiation oncologist to ensure they have the opportunity to receive standard-of-care cCRT followed by IMFINZI1,2

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend evaluation of RT eligibility by a radiation oncologist for all patients with Stage III NSCLC3*

Determination of the appropriateness of radiation therapy should be made by radiation oncologists for all patients with Stage III NSCLC3

Initiate IMFINZI as clinically appropriate after cCRT, and treat for up to 12 months until disease progression or unacceptable toxicity1

Pacific Regimen of IMFINZI as Clinically Appropriate After CRT Pacific Regimen of IMFINZI as Clinically Appropriate After CRT

In PACIFIC, scans were performed following cCRT within 0 to 42 days to assess disease progression5§

  • Preferred method of assessment of target lesions was computed tomography or MRI (to be used where computed tomography is not feasible)5||
  • Sites were encouraged to perform computed tomography/MRI within 14 days post-CRT and within 28 days prior to starting IMFINZI5
  • Patients had to complete their last dose of radiation therapy within 1 to 42 days prior to receiving IMFINZI5||
  • Initiating IMFINZI was allowed to be delayed by up to 42 days from the end of CRT for patients who are recovering from toxicities associated with prior treatment5

IMFINZI was initiated within 42 days following cCRT,1 and patients were randomized to receive IMFINZI if they had

  • No evidence of disease progression5§
  • Sites were encouraged to perform computed tomography/MRI within 14 days post-CRT5
  • CRT ARs Grade ≤2 except for pneumonitis5
  • Residual Grade ≤2 CRT ARs or Grade ≤1 CRT-induced pneumonitis5¶

Initiate IMFINZI as soon as clinically possible after the completion of cCRT5

Study design: The PACIFIC study was a large, Phase III, randomized, double-blind, placebo-controlled, international study of 713 patients with unresectable Stage III NSCLC who had not progressed following concurrent, platinum-based CRT. Patients had completed at least 2 cycles of concurrent CRT within 42 days prior to initiation of the study drug and had a WHO performance status of 0 or 1. Randomization at enrollment was stratified according to age, sex, and smoking history. Patients were randomized 2:1 to receive 10 mg/kg of IMFINZI or placebo every 2 weeks for up to 12 months or until unacceptable toxicity or confirmed disease progression. Coprimary endpoints were PFS (measured based on RECIST v1.1 criteria by BICR) and OS. Secondary endpoints included: Percentage of patients alive without disease progression at 12 and 18 months, ORR, DoR, and TTDM.1,5

*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

†In patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemoradiotherapy.1

‡Refer to Prescribing Information for information on dosage modifications.

§According to RECIST v1.1, patients have stable disease as long as target lesions only grow by <20% and no new lesions develop. Progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or the appearance of 1 or more new lesions.6

||The preferred method of assessment in PACIFIC for all lesions was computed tomography. Non-target lesions were also assessed by: MRI, clinical examination, or x-ray/chest x-ray. New lesions were also assessed by: MRI, clinical examination, x-ray/chest x-ray, ultrasound, and bone scan.5

Initially, patients with Grade 1 CRT-induced pneumonitis were excluded from the study.5

ARs=adverse reactions; BICR=blinded independent central review; cCRT=concurrent chemoradiotherapy; CRT=chemoradiotherapy; CT=chemotherapy; DoR=duration of response; Gy=gray; MRI=magnetic resonance imaging; NCCN=National Comprehensive Cancer Network® (NCCN®); NSCLC=non-small cell lung cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors; RT=radiotherapy; TTDM=time to death or distant metastasis; WHO=World Health Organization.

IMFINZI AFTER cCRT REAL-WORLD EVIDENCE
+

SEE FULL INDICATIONS

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).

Severe and Fatal Immune-Mediated
Adverse Reactions

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not

IMPORTANT SAFETY INFORMATION

There are no contraindications for IMFINZI® (durvalumab) or IMJUDO® (tremelimumab-actl).

Severe and Fatal Immune-Mediated
Adverse Reactions

Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Immune-Mediated Pneumonitis

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

  • IMFINZI as a Single Agent
    • In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
    • In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
    • The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
    • The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
  • IMFINZI with IMJUDO
    • Immune-mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.

Immune-Mediated Colitis

IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.

  • IMFINZI as a Single Agent
    • Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
  • IMFINZI with IMJUDO
    • Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.

Immune-Mediated Hepatitis

IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.

  • IMFINZI as a Single Agent
    • Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
  • IMFINZI with IMJUDO
    • Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.

Immune-Mediated Endocrinopathies

  • Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
    • IMFINZI as a Single Agent
      • Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
    • IMFINZI with IMJUDO
      • Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
  • Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
    • IMFINZI as a Single Agent
      • Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
    • IMFINZI with IMJUDO
      • Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
  • Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism): IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
    • IMFINZI as a Single Agent
      • Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
      • Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
      • Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
    • IMFINZI with IMJUDO
      • Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
      • Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
      • Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
      • Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
      • Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
    • IMFINZI with Carboplatin and Paclitaxel
      • Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
  • Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
    • IMFINZI as a Single Agent
      • Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
    • IMFINZI with IMJUDO
      • Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
    • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
      • Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Nephritis with Renal Dysfunction

IMFINZI and IMJUDO can cause immune-mediated nephritis.

  • IMFINZI as a Single Agent
    • Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
  • IMFINZI with IMJUDO
    • Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.

Immune-Mediated Dermatology Reactions

IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

  • IMFINZI as a Single Agent
    • Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
  • IMFINZI with IMJUDO
    • Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Immune-Mediated Pancreatitis

IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.

Other Immune-Mediated Adverse Reactions

The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.

  • Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
  • Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
  • Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
  • Endocrine: Hypoparathyroidism.
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Infusion-Related Reactions

IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.

  • IMFINZI as a Single Agent
    • Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
  • IMFINZI with IMJUDO
    • Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
  • IMFINZI with IMJUDO and Platinum-Based Chemotherapy
    • Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.

Complications of Allogeneic HSCT after IMFINZI

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.

Lactation

There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.

Adverse Reactions

Unresectable Stage III NSCLC

  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
  • In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.

Resectable NSCLC

  • In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in ≥20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
  • In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (≥1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
  • In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.

Metastatic NSCLC

  • In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
  • In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.

Limited-stage Small Cell Lung Cancer

  • In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis or radiation pneumonitis and pneumonia.
  • In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in ≥1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).

Extensive-stage Small Cell Lung Cancer

  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%).
  • In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.

Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)

  • In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in ≥20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
  • In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).

Unresectable Hepatocellular Carcinoma (HCC)

  • In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in ≥20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
  • In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.

Primary Advanced or Recurrent dMMR Endometrial Cancer

  • In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (≥3%) were constipation (4.5%) and fatigue (4.5%).
  • In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (≥4%) were constipation (4.5%) and rash (4.5%).

BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

  • In patients with BCG-naïve, high-risk NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (≥20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
  • In patients with BCG-naïve, high-risk NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (≥1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (≥1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).

Muscle-Invasive Bladder Cancer (MIBC)

  • In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in ≥20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
  • In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (≥1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
  • In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in ≥1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).

Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)

  • In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
  • In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (≥2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of ≥2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who
    received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse
    reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
  • In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (≥2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
  • In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of ≥2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

You may report side effects related to AstraZeneca products Report side effects related to AstraZeneca products.

The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.

Indications:

IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors ≥4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.

IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).

IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).

IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.

IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC).

IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).

IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.

You may report side effects related to AstraZeneca products Report side effects related to AstraZeneca products.

References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Spigel DR, Faivre-Finn C, Gray JE, et al; PACIFIC Investigators. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311. 3. Data on File, US-84480, AstraZeneca Pharmaceuticals LP; 2024. 4. Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350. 5. Ramnath N, Dilling TJ, Harris LJ, et al. Treatment of stage III non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e314S-e340S. 6. Cheema PK, Rothenstein J, Melosky B, Brade A, Hirsh V. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42. 7. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929.
References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Spigel DR, Faivre-Finn C, Gray JE, et al; PACIFIC Investigators. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 4. Rodrigues G, Choy H, Bradley J, et al. Definitive radiation therapy in locally advanced non-small cell lung cancer: executive summary of an American Society for Radiation Oncology (ASTRO) evidence-based clinical practice guideline. Pract Radiat Oncol. 2015;5(3):141-148. 5. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929 (Including Protocol). 6. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. 7. Girard N, Bar J, Christoph DC, et al. Real-world 5-year survival outcomes with durvalumab after chemoradiotherapy in unresectable, stage III NSCLC: final data extraction from PACIFIC-R. Poster presented at: European Lung Cancer Congress; March 26-29, 2025; Paris, France. Poster 190P (Including Supplement). 8. Keytruda® (pembrolizumab) [Prescribing Information]. Rahway, NJ: Merck & Co., Inc.; 2025. 9. Opdivo® (nivolumab) [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Company; 2025. 10. Tecentriq® (atezolizumab) [Prescribing Information]. South San Francisco, CA: Genentech, Inc.; 2024. 11. Libtayo® (cemiplimab-rwlc) [Prescribing Information]. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC; 2024. 12. Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350. 13. Detterbeck FC, Boffa DJ, Kim AW, Tanoue LT. The eighth edition lung cancer stage classification. Chest. 2017;151(1):193-203. 14. Cushman TR, Gomez D, Kumar R, et al. Combining radiation plus immunotherapy to improve systemic immune response. J Thorac Dis. 2018;10(suppl 3):S468-S479. 15. Melillo G, Chand V, Yovine A, Gupta A, Massacesi C. Curative-intent treatment with durvalumab in early-stage cancers. Adv Ther. 2021;38(6):2759-2778. 16. Deng L, Liang H, Burnette B, et al. Irradiation and anti–PD-L1 treatment synergistically promote antitumor immunity in mice. J Clin Invest. 2014;124(2):687-695. 17. Galon J, Bruni D. Approaches to treat immune hot, altered and cold tumours with combination immunotherapies. Nat Rev Drug Discov. 2019;18(3):197-218. 18. Stewart R, Morrow M, Hammond SA, et al. Identification and characterization of MEDI4736, an antagonistic anti–PD-L1 monoclonal antibody. Cancer Immunol Res. 2015;3(9):1052-1062. 19. Weichselbaum RR, Liang H, Deng L, Fu YX. Radiotherapy and immunotherapy: a beneficial liaison? Nat Rev Clin Oncol. 2017;14(6):365-379. 20. Ko EC, Raben D, Formenti SC. The integration of radiotherapy with immunotherapy for the treatment of non–small cell lung cancer. Clin Cancer Res. 2018;24(23):5792-5806. 21. Dovedi SJ, Illidge TM. The antitumor immune response generated by fractionated radiation therapy may be limited by tumor cell adaptive resistance and can be circumvented by PD-L1 blockade. Oncoimmunology. 2015;4(7):e1016709. 22. Lamberti G, Sisi M, Andrini E, et al. The mechanisms of PD-L1 regulation in non-small-cell lung cancer (NSCLC): which are the involved players? Cancers (Basel). 2020;12(11):3129. 23. Dovedi SJ, Adlard AL, Lipowska-Bhalla G, et al. Acquired resistance to fractionated radiotherapy can be overcome by concurrent PD-L1 blockade. Cancer Res. 2014;74(19):5458-5468. 24. Williamson CW, Sherer MV, Zamarin D, et al. Immunotherapy and radiation therapy sequencing: state of the data on timing, efficacy, and safety. Cancer. 2021;127(10):1553-1567.
References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):23‌42-23‌50. 3. Spigel DR, Faivre-Finn C, Gray JE, et al; PACIFIC Investigators. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311. 4. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929. 5. Data on File, REF-129952, AstraZeneca Pharmaceuticals LP; 2021. 6. Detterbeck FC, Boffa DJ, Kim AW, Tanoue LT. The eighth edition lung cancer stage classification. Chest. 2017;151(1):193-203. 7. Goldstraw P, Crowley J, Chansky K, et al; International Association for the Study of Lung Cancer International Staging Committee and Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of Malignant Tumours. J Thorac Oncol. 2007;2(8):706-714. 8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2025. ©National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 9. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247.
References: 1. Girard N, Bar J, Christoph DC, et al. Real-world 5-year survival outcomes with durvalumab after chemoradiotherapy in unresectable, stage III NSCLC: final data extraction from PACIFIC-R. Poster presented at: European Lung Cancer Congress; March 26-29, 2025; Paris, France. Poster 190P (Including Supplement). 2. Girard N, Bar J, Garrido P, et al. Treatment characteristics and real-world progression-free survival in patients with unresectable stage III NSCLC who received durvalumab after chemoradiotherapy: findings from the PACIFIC-R Study. J Thorac Oncol. 2023;18(2):181-193. 3. Girard N, Christoph DC, Garassino MC, et al. Real-world overall survival with durvalumab after chemoradiotherapy in patients with unresectable stage III non-small-cell lung cancer (NSCLC): interim analysis from the PACIFIC-R study. Presented at: ESMO Immuno-Oncology Annual Congress; December 7, 2022; Geneva, Switzerland. Abstract 580. 4. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 5. Spigel DR, Faivre-Finn C, Gray JE, et al; PACIFIC Investigators. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311. 6. Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350.
References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Spigel DR, Faivre-Finn C, Gray JE, et al; PACIFIC Investigators. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311. 3. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929. 4. Daniels GA, Guerrera AD, Katz D, Viets-Upchurch J. Challenge of immune-mediated adverse reactions in the emergency department. Emerg Med J. 2019;36(6):369-377.
References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.8.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed August 15, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

References: 1. IMFINZI® (durvalumab) [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2023. 2. Antonia SJ, Villegas A, Daniel D, et al. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. N Engl J Med. 2018;379(24):2342-2350. 3. Spigel DR, Faivre-Finn C, Gray JE, et al. Five-year survival outcomes from the PACIFIC trial: durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. J Clin Oncol. 2022;40(12):1301-1311. 4. Ramnath N, Dilling TJ, Harris LJ, et al. Treatment of stage III non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 suppl):e314S-e340S. 5. Cheema PK, Rothenstein J, Melosky B, Brade A, Hirsh V. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42. 6. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non–small-cell lung cancer. N Engl J Med. 2017;377(20):1919-1929. 7. Paz-Ares L, Chen Y, Reinmuth N, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN [published online ahead of print, March 10, 2022]. ESMO Open. 2022;7(2):100408. doi:10.1016/j.esmoop.2022.100408. 8. US Food & Drug Administration. FDA approves durvalumab for extensive-stage small cell lung cancer. Last updated March 30, 2020. Accessed May 8, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-extensive-stage-small-cell-lung-cancer. 9. Liu SV, Reck M, Mansfield AS, et al. Updated overall survival and PD-L1 subgroup analysis of patients with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposide (IMpower133). J Clin Oncol. 2021;39(6):619-630. 10. Paz-Ares L, Dvorkin M, Chen Y, et al. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Lancet. 2019;394(10212):1929-1939.

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