Durvalumab improves survival in limited-stage small cell lung cancer
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Durvalumab extended OS and PFS compared with placebo for patients with limited-stage small cell lung cancer, according to topline data released by 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 and other countries for treatment of extensive-stage small cell lung cancer, as well as for treatment of unresectable stage III non-small cell lung cancer whose disease has not progressed after chemoradiotherapy.
The randomized phase 3 ADRIATIC trial included 730 patients with limited-stage small cell lung cancer who had not progressed after concurrent chemoradiotherapy.
The trial — conducted at 164 centers in 19 countries — evaluated three regimens: durvalumab monotherapy, durvalumab plus tremelimumab-actl (Imjudo, AstraZeneca), or placebo.
In the experimental groups, patients received a fixed dose of 1,500 mg durvalumab alone or in combination with 75 mg tremelimumab-actl every 4 weeks for up to four doses.
The trial met its dual primary endpoints, showing improved PFS and OS with durvalumab monotherapy compared with placebo. These data will be presented at a medical meeting, according to an AstraZeneca press release.
“Many patients treated for limited-stage small cell lung cancer face disease recurrence, and the standard of care has remained unchanged for decades. ADRIATIC is the first global phase 3 immunotherapy trial to deliver significant, clinically meaningful improvement in survival in this setting, marking a breakthrough for patients with this devastating disease,” Suresh Senan, PhD, the trial’s principal investigator and professor of clinical experimental radiotherapy at Amsterdam University Medical Center, said in the release.
Key secondary endpoints included PFS and OS for durvalumab plus tremelimumab-actl compared with placebo. That component of the trial will continue to the next planned analysis.
Other secondary endpoints included safety and quality-of-life measures.
In the ADRIATIC trial, durvalumab exhibited a safety profile consistent with prior reports. Researchers observed no new safety signals.
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