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.
AstraZeneca's Trixeo Aerosphere approved in EU for asthma maintenance treatment
Insmed's ARIKAYCE sNDA granted priority review by FDA
Precigen announces FDA platform technology designation for AdenoVerse
Kelun-Biotech publishes phase III data for trastuzumab botidotin in HER2-positive breast cancer
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Akeso presents positive results from registrational Phase III study of ivonescimab
Insilico Medicine doses first patient in Phase III trial of rentosertib
Altesa BioSciences presents positive vapendavir clinical data at ERS International Congress 2026
Akeso's ivonescimab meets overall survival endpoint in interim analysis of Phase III HARMONi-2 study
AstraZeneca completes global licence agreement for Zegfrovy
Kazia Therapeutics reports 100% clinical benefit rate in initial paxalisib breast cancer trial
Oxcia receives EMA orphan designation for OXC-201 in idiopathic pulmonary fibrosis
Cizzle Bio presents CIZ1B biomarker blood test for lung cancer at Next Generation Dx Summit
Maverix Medical's Narwhal Cryo System receives FDA 510(k) clearance