Pembrolizumab Improved OS, PFS as First-Line Treatment in NSCLC

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Pembrolizumab significantly improved overall survival (OS) and progression-free survival (PFS) as first-line treatment for squamous non–small cell lung cancer (NSCLC) in the pivotal phase 3 KEYNOTE-407 trial.

Pembrolizumab (Keytruda) has now demonstrated improved survival benefit in patients with advanced non—small cell lung cancer (NSCLC) in 5 phase 3 trials as Merck announced that the anti—PD-1 therapy, in combination with paclitaxel, as first-line treatment for metastatic squamous NSCLC, improved survival in the phase 3 KEYNOTE-407 trial.

Based on an interim analysis, the addition of pembrolizumab to carboplatin-paclitaxel or nab-paclitaxel demonstrated longer overall survival (OS) and progression-free survival (PFS) than chemotherapy alone, meeting the study’s dual primary end points.

The safety profile of the therapy in the combination was consistent with that previously observed in lung cancer, according to Merck.


“As first-line treatment, Keytruda in combination with traditional chemotherapy has not demonstrated an improved survival benefit, compared to chemotherapy alone, in metastatic lung cancer patients with squamous histology,” said Roger M. Perlmutter, MD, president, Merck, in a statement.

KEYNOTE-407 is a randomized, double-blind, placebo-controlled phase 3 trial including 560 untreated patients with metastatic squamous NSCLC. Patients had no previous systemic therapy for advanced disease. Primary endpoints were OS and PFS, and secondary endpoints included objective response rate, which was alpha-controlled in a cohort of the first 200 patients, and duration of response.

Data from the trial will be presented at the 2018 ASCO Meeting held in Chicago, Illinois, from June 1-5.

Last month, Merck announced that pembrolizumab monotherapy as first-line treatment in locally advanced or metastatic NSCLC met its primary endpoint of OS in the phase 3 KEYNOTE-042 trial. When compared with platinum-based chemotherapy in patients with a PD-L1 tumor proportion score of 1% or higher, the therapy significantly improved OS.

Shortly after, the pharmaceutical company announced that the FDA had granted priority review to their Biologics License Application for pembrolizumab in combination with pemetrexed (Alimta) and platinum chemotherapy as first-line treatment for patients with metastatic nonsquamous NSCLC. The acceptance was based on OS and PFS data from the phase 3 KEYNOTE-189 trial.