Updated Data from Phase 3 KEYNOTE-045 Trial to Be Presented at ESMO 2017 Congress
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from the phase 3 KEYNOTE-045 trial evaluating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) with disease progression on or after platinum-containing chemotherapy (post-platinum failure). Updated data show that with median follow-up of 22.5 months, KEYTRUDA continues to demonstrate an overall survival (OS) benefit over investigator’s choice of paclitaxel, docetaxel or vinflunine as a second-line therapy, post-platinum failure, regardless of PD-L1 expression (HR, 0.70 [95% CI, 0.57-0.86], p=0.0003). Findings are being presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, on Sunday, Sept. 10 (poster from 2:45 – 4:15 p.m. CEST; discussion: 3:15 – 3:45 p.m. CEST) (Location: Cordoba Auditorium) (Abstract #LBA37_PR).
“These data at ESMO provide further insights and greater understanding in using KEYTRUDA in select second-line advanced urothelial carcinoma treatment settings, and importantly, demonstrate an overall survival advantage with KEYTRUDA compared to standard chemotherapy agents vinflunine, docetaxel and paclitaxel, which are common in clinical practice for the treatment of this disease,” said professor Ronald de Wit, M.D., Ph.D., group leader experimental systemic therapy of urogenital cancers, Erasmus MC Cancer Institute. “For previously treated patients, post-platinum failure, these findings are also encouraging as they show an overall survival benefit regardless of PD-L1 status or choice of commonly used chemotherapy.”
“With nearly two years follow-up, these updated phase 3 data continue to show an overall survival benefit with KEYTRUDA in patients with advanced urothelial carcinoma whose cancer has progressed after receiving previous treatment for their disease,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are pleased that, with the approval in the U.S. and recent approval of KEYTRUDA in the EU, more patients now have an important treatment option available to them.”
Currently, Merck also has the largest immuno-oncology clinical development program in bladder cancer, with 29 trials underway involving KEYTRUDA (pembrolizumab) as monotherapy and in combination, including four registration-enabling studies.
Data in Second-Line Post-Platinum Failure Patients, KEYNOTE-045
KEYNOTE-045 is an open-label, randomized phase 3 trial of KEYTRUDA compared to investigator’s choice of chemotherapy (paclitaxel, docetaxel or vinflunine) in patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy. The trial was prematurely stopped after a pre-planned interim analysis demonstrated significantly longer OS with KEYTRUDA compared to chemotherapy (median follow-up, 14.1 months). Efficacy was assessed in the overall study population (n=542), as well as in patients with PD-L1 expression – defined as a combined positive score of 10 or more (CPS =10) (KEYTRUDA arm: n=74/270; chemotherapy arm; n=90/272) (additional details on the trial design are provided below).
