FDA approves Imfinzi regimen for resectable non-small cell lung cancer
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The FDA expanded the approval of durvalumab for lung cancer.
The new indication applies to use of the agent with platinum-containing chemotherapy in the neoadjuvant setting, followed by single-agent therapy in the adjuvant setting, for patients with resectable NSCLC who have no known EGFR or ALK rearrangements.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
It is approved in the United States for multiple oncology indications, including treatment of certain patients with NSCLC, small cell lung cancer, bile duct cancer, gallbladder cancer, hepatocellular carcinoma or endometrial cancer.
The FDA based the new indication on results of the randomized phase 3 AEGEAN trial, which included 802 patients with previously untreated resectable squamous or nonsquamous NSCLC.
Researchers assigned half of the trial participants to neoadjuvant platinum-based chemotherapy with durvalumab every 3 weeks for up to four cycles, followed by adjuvant treatment with single-agent durvalumab every 4 weeks for up to 12 cycles. The other half received neoadjuvant chemotherapy plus placebo, followed by placebo after surgery.
EFS by blinded independent central review assessment and pathologic complete response by blinded central pathology review served as major efficacy outcomes.
Results showed longer median EFS (not reached vs. 25.9 months; HR = 0.68; 95% CI, 0.53-0.88) and a higher pathologic complete response rate (17% vs. 4.3%) in the durvalumab group.
The most common adverse reactions reported among patients assigned durvalumab included nausea, anemia, constipation, fatigue, rash and musculoskeletal pain.
A comparable percentage of patients assigned durvalumab and placebo could not undergo surgery due to adverse reactions (1.7% vs. 1%).
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