First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract OA14.01).
“With more than 3 years’ follow-up, first-line pembrolizumab monotherapy continued to provide durable long-term OS benefit vs chemotherapy, despite a majority of patients assigned to chemotherapy crossing over to pembrolizumab."— Martin Reck, MD, PhD
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Dr. Reck and his research colleagues had previously presented preliminary data on KEYNOTE-024, and at the WCLC, he shared 3-year follow-up data.
More on KEYNOTE-024
In the phase III KEYNOTE-024 trial, first-line pembrolizumab significantly improved progression-free survival and overall survival compared with platinum-based chemotherapy in patients with advanced NSCLC with a programmed cell death ligand 1 tumor proportion score of ≥ 50% and no targetable EGFR/ALK alterations.
Patients were randomly assigned to receive pembrolizumab 200 mg for 2 years or a platinum chemotherapy doublet for four to six cycles plus optional maintenance (in those with nonsquamous histology), with stratification by Eastern Cooperative Oncology Group score of 0 or 1, tumor histology (squamous/nonsquamous), and region (East Asia/non‒East Asia). Patients in the chemotherapy arm could cross over to pembrolizumab upon disease progression if they met eligibility criteria. The primary endpoint was progression-free survival, and overall survival (OS) was a key secondary endpoint.
Findings
The median overall survival length among patients in the pembrolizumab arm was 26.3 months vs 14.2 months in the chemotherapy arm. The 36-month overall survival rate was 43.7% in the pembrolizumab arm vs 24.9% in the chemotherapy arm. Despite longer mean treatment duration in the pembrolizumab arm (11.1 vs 4.4 months), grade 3‒5 treatment-related adverse events were less frequent with pembrolizumab vs chemotherapy.
“With more than 3 years’ follow-up, first-line pembrolizumab monotherapy continued to provide durable long-term OS benefit vs chemotherapy, despite a majority of patients assigned to chemotherapy crossing over to pembrolizumab,” said Dr. Reck in a press release. “And pembrolizumab was associated with less toxicity than chemotherapy. Patients who completed 35 cycles of pembrolizumab had durable clinical benefit, and most were alive at data cutoff.”
Disclosure: For full disclosures of the study authors, visit wclc2019.iaslc.org.