KEYTRUDA Monotherapy Significantly Improved Overall Survival in KEYNOTE-042 Study as First-Line Treatment for Locally Advanced or Metastatic NSCLC Patients Whose Tumors Expressed PD-L1 (TPS ?1%)

Study Results Confirm KEYTRUDA is the Only Anti-PD-1 Therapy to Show an Overall Survival Benefit as Monotherapy in First-Line NSCLC

KEYNOTE-042 to be Presented in Plenary Session at 2018 ASCO Annual Meeting

KENILWORTH, N.J., June 3, 2018 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-042, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. In this study, KEYTRUDA monotherapy resulted in significantly longer overall survival (OS) than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent (HR=0.69 [95% CI, 0.56-0.85]; p=0.0003), with a TPS of ≥20 percent (HR=0.77 [95% CI, 0.64-0.92]; p=0.0020), and then in the entire study population with a TPS of ≥1 percent (HR=0.81 [95% CI, 0.71-0.93]; p=0.0018). These results will be presented today in the plenary session and during the Sunday press program at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA4).

The attached news release crossed the wire today, Sunday, June 3, 2018 at 7:30 a.m. ET

• KEYTRUDA Monotherapy Significantly Improved Overall Survival in KEYNOTE-042 Study as First-Line Treatment for Locally Adv

Republicado por:RM Consult