publication date: May. 4, 2018
Keytruda meets ORR endpoint in interim analysis of phase III trial in NSCLC
Merck said the pivotal phase III 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 met a pre-specified secondary endpoint of overall response rate in an early cohort of participants at an interim analysis.
Based on these data, Merck has submitted a supplemental Biologics License Application to FDA.
This study has been accepted for oral presentation at the American Society of Clinical Oncology 2018 Annual Meeting. The company said 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 III 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. Patients were required to have no previous systemic therapy for advanced disease. The dual primary endpoints were overall survival and progression-free survival; secondary endpoints included objective response rate, which was alpha-controlled in a cohort of the first 200 patients, and duration of response.