Therapy Areas: Respiratory
Merck's Keytruda as Monotherapy Significantly Improves Overall Survival as First-Line Therapy in NSCLC Patients Expressing PD-L1 in at Least 1% of Tumor Cells
11 April 2018 - - Kenilworth, New Jersey-based global healthcare solutions provider Merck's (NYSE: MRK) Phase 3 KEYNOTE-042 trial evaluating Keytruda, the company's anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), including nonsquamous or squamous histologies, met its primary endpoint of overall survival (OS), the company said.
An interim analysis conducted by the independent data monitoring committee (DMC) demonstrated that treatment with Keytruda resulted in significantly longer OS than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1%.
As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50%, with a TPS of ≥20% and then in the entire study population with a TPS of ≥1%.
Based on the recommendation of the DMC, the trial will continue to evaluate progression-free survival, which is a secondary endpoint.
KEYNOTE-042 is an international, randomized, open-label Phase 3 study investigating Keytruda monotherapy compared to standard of care platinum-based chemotherapy in patients with locally advanced or metastatic PD-L1 positive (TPS ≥1%) NSCLC.
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with Keytruda in combination with other treatments and as monotherapy. The program, which is comprised of nearly 9,000 patients across 15 clinical studies, is evaluating Keytruda across multiple settings and stages of the disease.
Merck, known as MSD outside of the US and Canada, provides healthcare solutions worldwide through four segments: pharmaceutical, animal health, healthcare services, and alliances. The company serves drug wholesalers and retailers, hospitals, government agencies and entities, physicians, physician distributors, veterinarians, distributors, animal producers, and managed health care providers.
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