Update on Tarextumab Phase 2 Programs on Pancreatic and SCLung Cancers

OncoMed Pharmaceuticals Inc., a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updates on the tarextumab (anti-Notch 2/3, OMP-59R5) Phase 2 programs in pancreatic cancer (the “ALPINE” study) and small cell lung cancer (the “PINNACLE” study).  OncoMed will continue the PINNACLE Phase 2 trial of tarextumab in small cell lung cancer following a review of unblinded safety and efficacy data from both the ALPINE and PINNACLE studies by the U.S. Food and Drug Administration (FDA) and the PINNACLE Data Safety Monitoring Board (DSMB).  The PINNACLE study remains blinded to OncoMed, investigators and patients.  OncoMed has discontinued dosing of tarextumab in the Phase 2 ALPINE clinical study. 

“After communicating with the FDA and the PINNACLE trial DSMB we have received feedback that appropriate safety monitoring is in place to continue the PINNACLE trial,” said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed.  “While we remain blinded to the PINNACLE trial data, differences in pancreatic and small cell lung cancer biology, combined with our understanding of the potential mechanisms of tarextumab, give us confidence to continue the PINNACLE Phase 2 clinical trial.”
Ongoing analyses conducted by OncoMed revealed subgroups of patients with decreased survival and a subgroup which appears to exhibit improved survival with tarextumab.  OncoMed will continue to analyze the ALPINE data, and present the data at a future medical meeting.