IMFINZI FOLLOWING cCRT:
THE ADRIATIC REGIMEN

In adults with LS-SCLC whose disease has not progressed following cCRT1

Initiate IMFINZI as clinically appropriate after the completion of cCRT

Continue treatment with IMFINZI for up to 24 months following cCRT or until disease progression or unacceptable toxicity1

   

While 4 cycles were tested and received by 88.3% of patients, not all patients received 4 cycles. Three cycles of platinum-based chemotherapy were permitted if disease control was achieved and no additional benefit was expected from an additional cycle as determined by the investigator. 66.2% of patients received cisplatin-etoposide and 33.8% received carboplatin-etoposide. Scans were performed following cCRT within 0 to 42 days, to assess disease progression, prior to initiation of IMFINZI.2

In the ADRIATIC study, scans were performed within 42 days following cCRT to assess disease progression2

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Preferred method of assessment of target lesions was computed tomography or MRI (to be used where computed tomography is not feasible)2§

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Baseline imaging was to be performed within 42 days following cCRT and ideally as close as possible prior to starting IMFINZI2

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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 initial treatment2

Discuss the full treatment regimen with your patients: IMFINZI following cCRT for up to 24 months1

Study design: The ADRIATIC study was a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study that assessed IMFINZI ± tremelimumab as consolidation treatment for patients with LS-SCLC who had not progressed after cCRT. Eligible patients had medically inoperable Stage I-III LS-SCLC and a WHO performance status of 0 or 1, and had not progressed after cCRT. PCI was permitted before randomization. Patients were randomized 1-42 days after completion of cCRT to IMFINZI 1500 mg + placebo, IMFINZI 1500 mg + tremelimumab 75 mg, or placebo + placebo Q4W for 4 cycles, followed by IMFINZI (IMFINZI ± tremelimumab arms) or placebo Q4W until investigator-determined progression, an intolerable toxicity, or for a maximum of 24 months. The first 600 patients were randomized in a 1:1:1 ratio; subsequent patients were randomly assigned 1:1 to IMFINZI or placebo. Randomization was stratified by Stage (I/II vs III) and receipt of PCI (yes vs no). The dual primary endpoints were OS and PFS (BICR per RECIST v1.1) for IMFINZI vs placebo. OS and PFS for IMFINZI + tremelimumab vs placebo were alpha-controlled secondary endpoints and remain blinded until the next analysis.1,2

*Patients must have demonstrated CR, PR, or SD, and have not progressed following cCRT.2

†60 to 66 Gy once daily (QD) over 6 weeks or 45 Gy twice daily (BID) over 3 weeks.1

‡Infuse IMFINZI for up to 24 months or until disease progression or unacceptable toxicity.1

§The preferred method of assessment in ADRIATIC for all lesions was computed tomography, except for brain lesions, where MRI was the preferred method of assessment. Non-target lesions were also assessed by: MRI, plain x-ray, or chest x-ray. New lesions were also assessed by: MRI, plain x-ray, chest x-ray, bone scan, or ultrasound.2

BICR=blinded independent central review; cCRT=concurrent chemoradiation therapy; CR=complete response; CRT=chemoradiotherapy; CT=chemotherapy; Gy=gray; LS-SCLC=limited-stage small cell lung cancer; MRI=magnetic resonance imaging; OS=overall survival; PCI=prophylactic cranial irradiation; PFS=progression-free survival; PR=partial response; Q4W=every 4 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; RT=radiotherapy; SD=stable disease; WHO=World Health Organization.