Pembrolizumab extended PFS and OS compared with chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer whose tumors expressed high levels of programmed death-ligand 1, according to study results released by the drug’s manufacturer.
The phase 3 KEYNOTE-024 trial included 305 patients with advanced disease. All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.
Researchers randomly assigned study participants to 200 mg pembrolizumab (Keytruda, Merck) administered via IV infusion every 3 weeks or standard platinum-based chemotherapy. Pemetrexed (Alimta, Eli Lilly) maintenance was allowed for patients with nonsquamous histologies, and patients assigned to the control arm had the option to cross over to pembrolizumab upon disease progression.
PFS served as the primary endpoint and OS served as a secondary endpoint.
Pembrolizumab proved superior with regard to PFS and OS, according to the press release. An independent data monitoring committee recommended the trial be stopped because of the results, and that patients assigned chemotherapy be offered the opportunity to switch to pembrolizumab.
The safety profile of pembrolizumab appeared consistent with that observed in prior studies of patients with advanced NSCLC. The most common adverse reactions reported in at least 20% of trial participants include fatigue (44%), cough (29%), decreased appetite (25%) and dyspnea (23%).
The results will be submitted for presentation at a future medical meeting.
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non–small cell lung cancer,” Roger M. Perlmutter, MD, president of Merck Research Laboratories, said in the release. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”
Pembrolizumab — a humanized monoclonal antibody — is approved for treatment of patients with unresectable or metastatic melanoma. It also is approved for treatment of patients with metastatic, PD-L1–expressing non–small cell lung cancer who progressed on or after platinum-containing chemotherapy.