Rafael Pharmaceuticals Inc. (NASDAQ: RFL) has announced that its AVENGER 500 third phase clinical trial evaluating CPI-613’s (devimistat) safety and efficacy in combination with improved FOLFIRINOX 9 (mFFX) as a first-line treatment in metastatic adenocarcinoma of the pancreas patients failed to meet the primary objective of overall survival.
The study evaluated 528 patients
In this global Phase 3 randomized clinical study, the company evaluated 528 patients with metastatic pancreatic adenocarcinoma. Eligible patients were those that had previously not received treatment who were randomized to receive devimistat in combination mFFX or FOLFIRINOX, the current standard of care chemotherapy regimen. Overall survival did not improve significantly when Devimistat was combined with mFFX. The devimistat plus mFFX cohort’s median overall survival was 11.1 months relative to 11.7 months in the FOLFIRINOX cohort.
CEO and President of Rafael Pharmaceutical Sanjeey Ruther said, “These cancers are incredibly difficult to treat, with few to no effective treatments available, but Rafael took the risk because we will always fight for our patients. While we are disappointed by the outcomes of these well-designed and well-executed studies, we remain committed to furthering our research and development in cancer metabolism for the treatment of hard-to-treat cancers, as our other studies continue. I personally want to express my heartfelt appreciation to the patients, their loved ones, the researchers and principal investigators for their trust and support.”
Pancreatic cancer has a high mortality rate
Principal investigator Philip Philip said, “Pancreatic cancer carries a high mortality rate and is extremely difficult to treat, but promising earlier clinical data encouraged us to move into this advanced phase trial with devimistat. While these are not the results we all hoped for, we will not give up, and we are hopeful that devimistat with its novel mechanism of action will demonstrate efficacy in other studies. We are working diligently to further analyze the data and determine the best plan of action to further assess the drug’s capabilities in the clinic.”
