Adjuvant durvalumab does not extend DFS in early-stage lung cancer
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Adjuvant durvalumab failed to improve outcomes compared with placebo for certain patients with early-stage lung cancer, according to the agent’s manufacturer.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
The agent is approved in the United States for several oncology indications, including treatment of certain patients with lung, bile duct, gallbladder, liver or endometrial cancers.
The randomized phase 3 ADJUVANT BR.31 trial included 1,415 patients with stage IB, II or IIIA non-small cell lung cancer who underwent complete tumor resection with or without adjuvant chemotherapy.
Researchers randomly assigned patients 2:1 to 20 mg/kg durvalumab via IV infusion or placebo every 4 weeks for up to 48 weeks.
DFS among patients whose tumors expressed PD-L1 on 25% or more tumor cells and who did not have common EGFR mutations or ALK rearrangements served as the primary endpoint.
Results showed no significant DFS improvement in this patient population.
Durvalumab exhibited a safety profile consistent with that observed in prior studies. Researchers observed no new safety concerns.
“We are disappointed in the ADJUVANT BR.31 results,” Susan Galbraith, MBBChir, PhD, executive vice president of oncology research and development for AstraZeneca, said in a company press release. “Imfinzi has helped change the treatment landscape and achieved multiple positive phase 3 trials for patients with earlier stages of lung cancer. We are committed to addressing the remaining unmet need in lung cancer."
Complete data from the ADJUVANT BR.31 trial will be presented at a medical conference.
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