Pembrolizumab (Keytruda) met its primary endpoint in the pivotal phase 3 KEYNOTE-042 trial.
Merck’s anti-PDL therapy pembrolizumab (Keytruda) demonstrated positive results in the pivotal phase 3 KEYNOTE-042 trial as a first-line monotherapy treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), the company announced in a press release.
The treatment met its primary endpoint of overall survival (OS) in the trial and demonstrated significantly longer OS than platinum-based chemotherapy in patients with a PD-L1 tumor proportion score (TPS) of ³1%, according to the press release. Additionally, pembrolizumab’s safety profile was consistent with findings from previously reported monotherapy studies involving patients with advanced NSCLC.
Pembrolizumab is also indicated for the treatment of patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every 3 weeks until disease progression or unacceptable toxicity, according to Merck.
KEYNOTE-042 is a phase 3 study investigating pembrolizumab monotherapy compared with standard of care platinum-based chemotherapy in patients with locally advanced or metastatic PD-L1 positive NSCLC. Patients who participated in the trial had no EGFR or ALK genomic tumor aberrations and had not previously received systemic therapy for advanced disease. The primary endpoint is OS with TPS of ³50%, ³20%, and ³1%, according to the press release.
For the trial, 1274 patients were enrolled and randomized to receive either pembrolizumab (200 mg fixed dose every 3 weeks) as monotherapy or investigator’s choice of platinum-based chemotherapy.
Pembrolizumab works by increasing the ability of the body’s immune system to help detect and fight tumor cells. As a humanized monocloncal antibody, pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate T lymphocytes, which may affect both tumor cells and health cells.
Based on the recommendation of the Data Monitoring Committee, the clinical trial will continue to evaluate progression-free survival, which is the secondary endpoint.
Merck is continuing to advance multiple registration-enabling studies with pembrolizumab to evaluate the treatment across multiple settings and stages of the disease, according to the press release.
KEYTRUDA® (pembrolizumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells [news release]. Merck’s website. http://www.mrknewsroom.com/news-release/oncology-newsroom/keytruda-pembrolizumab-monotherapy-met-primary-endpoint-phase-3-keyno. Accessed April 12, 2018.