MONTHS MATTER IN ES-SCLC
MONTHS MATTER IN ES-SCLC
IMFINZI + EP: Sustained survival benefit at 2 years1*
*The hazard ratio was 0.73 at the interim analysis and 0.75 at the updated analysis.1,2
†Overall survival was the primary endpoint. At the time of the planned interim overall survival analysis with a median duration of follow-up of 14.2 months, mOS was 13 months (95% CI, 11.5-14.8) with IMFINZI + EP vs 10.3 months (95% CI, 9.3-11.2) with EP alone (HR=0.73; 95% CI, 0.59-0.91; P=0.0047).2,3
‡The updated OS analysis was conducted with a median duration of follow-up of 25.1 months. OS rates at 12, 18, and 24 months are the estimated proportion of patients alive based on the updated analysis.1.3
Months matter in ES-SCLC—Start with IMFINZI + EP for all eligible patients2
Durvalumab (IMFINZI®) + etoposide with either cisplatin or carboplatin is a Category 1, preferred treatment option for first-line ES-SCLC4§||
§Preferred intervention=intervention that is based on superior efficacy, safety, and evidence, and, when appropriate, affordability. Category 1=based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate. 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. To view the most recent and complete version of the guideline, go online to NCCN.org.
||See the NCCN Guidelines® for detailed recommendations, including other preferred treatment options.4
Overall survival with IMFINZI + EP remained consistent across all subgroups with >2 years of follow-up1
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OS subgroup analysis was not powered to show a statistically significant difference between or within individual subgroups.3
IMFINZI + EP was evaluated in key patient subgroups reflective of clinical practice in ES-SCLC, including3,5-9:
ES-SCLC=extensive stage small cell lung cancer; EP=etoposide and either carboplatin or cisplatin; mOS=median overall survival; HR=hazard ratio; CI-confidence interval; OS=overall survival; ECOG=Eastern Cooperative Oncology Group; WHO=World Health Organization; PS=performance status; CNS=central nervous system; AJCC=American Joint Committee on Cancer.
Landmark progression-free survival data for IMFINZI + EP with >2 years of median follow-up1,3
*PFS rates at 12, 18, and 24 months are the estimated proportion of patients alive and progression free based on the updated analysis.1
IMFINZI + EP provided a high response rate and demonstrated ongoing responses at 1 and 2 years1-3
RECIST=Response Evaluation Criteria in Solid Tumors.
*Investigator assessed per RECIST v1.1.
The Phase III CASPIAN study compared IMFINZI + EP vs EP and was designed to reflect real-world clinical practice3,6
A large, randomized, open-label, multicenter study of IMFINZI + etoposide and platinum-based chemotherapy (EP) vs EP alone2,3
Investigator’s choice of platinum-based chemotherapy3||
Patients with asymptomatic or treated brain metastases3¶
Up to 6 cycles of EP. 57% of patients received 6 cycles1,2
PCI per investigator’s discretion2,3
No PD-L1 testing was required3
Baseline patient characteristics were well balanced between the IMFINZI + EP and EP arms3
Patients with asymptomatic or treated brain or CNS metastases were eligible to start systemic treatment.1
|IMFINZI + EP (n=268)||EP alone (n=269)|
|Median age (years) (range)||62 (58-68)||63 (57-68)|
|Current smoker/former smoker||92%||94%|
|Brain or CNS metastases||10%||10%|
Q3W=once every 3 weeks; Q4W=once every 4 weeks; PCI=prophylactic cranial irradiation; ORR=objective response rate; HRQoL=health-related quality of life; PD-L1=programmed death-ligand 1; AUC=area under the curve; CT=computed tomography; MRI=magnetic resonance imaging.
*IMFINZI 1500 mg + either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or cisplatin (75 mg/m2-80 mg/m2) on Day 1 and etoposide (80 mg/m2-100 mg/m2) intravenously on Days 1, 2, and 3 of each 21-day cycle for 4 cycles, followed by IMFINZI 1500 mg every 4 weeks until disease progression or unacceptable toxicity.2,3
†Either carboplatin (AUC 5 mg/mL/min or 6 mg/mL/min) or cisplatin (75 mg/m2-80 mg/m2) on Day 1 and etoposide (80 mg/m2-100 mg/m2) intravenously on Days 1, 2, and 3 of each 21-day cycle for 4 to 6 cycles.2,3
‡8% of patients who were treated with EP alone received PCI post-EP.2,3
§Assessed using investigator assessments according to RECIST v1.1.3
||78% received carboplatin and 25% received cisplatin in the IMFINZI + EP arm; 78% received carboplatin and 25% received cisplatin in the EP alone arm.3
¶Patients with confirmed brain metastases had to be treated and stable off steroids and anticonvulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.3
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).
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 liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. 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 depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI 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.
IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2% (28/1414), 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 16.6% (79/475) in patients receiving IMFINZI and 13.2% (31/234) in patients receiving placebo. Of the 79 patients who received IMFINZI, 1.1% were fatal and 2.5% were Grade 3-4 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 when in combination with chemotherapy.
IMFINZI 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. Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.
IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1% (19/1889) of patients receiving IMFINZI, including fatal (<0.1%) and Grade 3 (0.6%) adverse reactions.
IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (5/1889) of patients receiving IMFINZI, including Grade 3 (0.1%) adverse reactions.
IMFINZI 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), have occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 1.6% (30/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.
IMFINZI 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 based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
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.
Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.
There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
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