Merck (NYSE:MRK), a United States-based pharmaceutical company, yesterday announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA (pembrolizumab), Merck's 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) met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis.
Based on these data, Merck has recently submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA).
This study has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The company now expects that an additional interim analysis will be conducted prior to ASCO and additional data may be available for the ASCO 2018 Annual Meeting.
KEYNOTE-407 (ClinicalTrials.gov, NCT 02775435) 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 squamous NSCLC.
IDEAYA Biosciences submits IND for IDE892; Targets Phase 1 in 4Q 2025
Airiver medical receives FDA approval for central airway stenosis trial
Calluna Pharma begins Phase 2 study of CAL101 in idiopathic pulmonary fibrosis
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Innovent Biologics receives approval over squamous cell lung cancer study
Novocure submits FDA PMA for Tumor Treating Fields therapy in pancreatic cancer
HUTCHMED completes enrollment in Phase III SANOVO trial of ORPATHYS and TAGRISSO in China