Bang!
Momenta Discontinues Further Accrual of its Phase 2 Trial of Necuparanib in Patients with Pancreatic Cancer Following Planned Interim Futility Analysis
CAMBRIDGE, Mass., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Company has discontinued further accrual in its Phase 2 trial evaluating necuparanib in combination with Abraxane® and gemcitabine in patients with advanced metastatic pancreatic cancer.
The decision to discontinue enrollment into the study was based on the recommendation from the independent Data Safety Monitoring Board (DSMB) following a planned interim futility analysis conducted once 57 deaths (50% of the target number of 114 events required for trial completion) had occurred. Data were assessed from 120 randomized patients as of July 20, 2016. While no new safety signals were observed and the toxicity profile was considered manageable, the DSMB determined that necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment. Additionally, no new toxicities were observed that necessitate immediate discontinuation of study drug in patients currently active on protocol. The DSMB also recommended that the company consider unblinding the data to provide more information to determine how best to address ongoing patients.
“We are extremely disappointed with the outcome of the futility analysis – in particular, for those patients with pancreatic cancer where there is still so much unmet need for safe and effective therapy,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “We agree with the DSMB recommendations and plan to confirm the futility analysis and determine next steps for the necuparanib program.”
“We are saddened that necuparanib did not produce the outcome we had hoped for in this patient population,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We would like to thank the investigators and their brave patients for participating in this trial as well as our staff and external advisors for their support throughout this program.”
