Therapy Areas: Respiratory
Merck Trial of Keytruda Combination for Treatment of sNSCLC Meets Secondary Endpoint of ORR at Interim Analysis
8 May 2018 - - The Phase 3 KEYNOTE-407 trial investigating Keytruda (pembrolizumab), Kenilworth, New Jersey-based global healthcare solutions provider Merck's (NYSE: MRK) anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as first line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), has met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis, the company said.
KEYNOTE-407 is a randomized, double-blind, placebo-controlled, Phase 3 study investigating Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel, compared with carboplatin-paclitaxel or nab-paclitaxel alone, in 560 untreated patients with metastatic sNSCLC. Patients were required to have had no previous systemic therapy for advanced disease.
The dual primary endpoints were overall survival and progression-free survival; secondary endpoints included ORR, which was alpha-controlled in a cohort of the first 200 patients, and duration of response.
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's immuno-oncology clinical research program currently involves more than 700 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.
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.