Adjuvant pembrolizumab extends DFS for certain patients with non-small cell lung cancer
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Pembrolizumab extended DFS compared with placebo as adjuvant treatment for patients with stage IB to stage IIIA non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Pembrolizumab (Keytruda, Merck) is an anti-PD-1 therapy approved for several oncology indications.
The randomized phase 3 KEYNOTE-091 trial included 1,177 patients with stage IB to stage IIIA NSCLC who underwent surgical resection with or without chemotherapy.
Researchers randomly assigned patients to 200 mg pembrolizumab or placebo via IV every 3 weeks for 1 year or up to 18 doses.
DFS in the entire study population, as well as among those whose tumors expressed PD-L1 — defined by tumor proportion score of 50% or greater — served as dual primary endpoints. Secondary endpoints included OS and lung cancer-specific survival.
An interim analysis performed by an independent data monitoring committee showed the study met one of its primary endpoints, as pembrolizumab-treated patients achieved significantly longer DFS regardless of PD-L1 expression.
Researchers also reported improved DFS with pembrolizumab for patients whose tumors expressed PD-L1; however, this benefit did not reach statistical significance.
The trial will continue to allow further analysis of DFS among patients whose tumors express high levels of PD-L1 and to evaluate OS.
The safety profile of pembrolizumab appeared consistent with that observed in prior studies.
Results of KEYNOTE-091 will be submitted for presentation at a medical meeting and shared with regulatory authorities, according to a Merck-issued press release.
“Keytruda has become foundational in the treatment of metastatic non-small cell lung cancer, and we continue to advance research to explore its potential to help fight cancer earlier,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development and chief medical officer for Merck Research Laboratories, said in the release. “We are encouraged by these results supporting the potential role of Keytruda in stage IB-IIIA non-small cell lung cancer.”
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