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Durvalumab extends PFS in advanced NSCLC
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Durvalumab significantly extended PFS compared with placebo among certain patients with locally advanced, unresectable non–small cell lung cancer, according to an interim analysis of a phase 3 trial.
The randomized, double blind, multicenter phase 3 PACIFIC trial assessed the safety and efficacy of durvalumab (Imfinzi, AstraZeneca) — a human monoclonal antibody directed against PD-L1 — compared with placebo for patients with stage III NSCLC who had not progressed following standard platinum-based chemotherapy and concurrent radiation therapy.
PFS and OS served as the primary endpoints. Secondary endpoints included landmark PFS and OS, objective response rate and duration of response.
Durvalumab conferred statistically significant PFS improvement as assessed by blinded independent review, according to an AstraZeneca-issued press release. The agent also exhibited a favorable risk–benefit profile.
“These are highly encouraging results for patients with locally advanced lung cancer for whom surgery is not an option,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in the press release. “We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible.”
The FDA granted accelerated approval to durvalumab for the treatment of previously treated patients with advanced bladder cancer.
Two phase 3 trials are underway to evaluate durvalumab as first-line treatment of NSCLC. Three phase 3 trials are assessing the agent in combination with tremelimumab (CP-675,206; AstraZeneca), a checkpoint inhibitor that targets CTLA-4.