Onconova Reports Combination of Rigosertib, Gemcitabine Unlikely to Demonstrate Statistically Significant Improvement i
Onconova Therapeutics (Nasdaq: ONTX) today announced the discontinuation of the Phase 3 ONTRAC study of intravenous (IV) rigosertib plus gemcitabine in front-line metastatic pancreatic cancer. Upon completion of a planned interim analysis, the Data Safety Monitoring Board (DSMB) determined that the combination of rigosertib and gemcitabine is unlikely to demonstrate a statistically significant improvement in overall survival compared to gemcitabine alone. There were no safety concerns raised in the DSMB review of the study.
The ONTRAC study is a randomized, multi-center, controlled Phase 3 trial of the safety and efficacy of gemcitabine alone and IV rigosertib combined with gemcitabine in patients with previously untreated metastatic pancreatic cancer. The study employed an adaptive design that allowed for an interim review of data to assess the rationale for continuing the evaluation of rigosertib plus gemcitabine in this patient population.
"We are very disappointed by these results, especially for patients with metastatic pancreatic cancer, given the lack of meaningful treatment options," said Ramesh Kumar, Ph.D., President and Chief Executive Officer of Onconova. "We would like to thank the patients and investigators