Rafael (RFL) AVENGER 500 Phase 3 clinical trial evaluating CPI-613 in combination with modified FOLFIRINOX (mFFX) as a first-line therapy in patients misses primary endpoint
- Wall Street closes higher with Nasdaq boosted by tech rally
- Apple (AAPL) Gets a New Street High Price Target, Morgan Stanley Says iPhone Supply and App Store Could Fuel December Quarter Beat
- 'No Rival to Get Even Close' - Tesla (TSLA) Shares Soar as UBS Raises Price Target by Nearly 40%
- Intel (INTC) Shares Surge on Plans to Take Mobileye Public, Morgan Stanley Says Move a Significant Positive
- Digital World Acquisition Corp. (DWAC) Stock Jumps As U.S. Congressman Nunes Leaves to Head Trump Media
Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.
Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a company focused on the growing field of cancer metabolism-based therapeutics, today announced that the AVENGER 500 Phase 3 clinical trial evaluating the efficacy and safety of CPI-613® (devimistat) in combination with modified FOLFIRINOX (mFFX) as a first-line therapy in patients with metastatic adenocarcinoma of the pancreas did not meet its primary endpoint of overall survival.
In this multi-national Phase 3 randomized clinical trial, 528 patients with metastatic adenocarcinoma of the pancreas who had no prior therapy were randomized to receive either devimistat in combination with modified FOLFIRINOX (mFFX) or FOLFIRINOX, a current standard of care chemotherapy regimen. Devimistat given with mFFX did not significantly improve overall survival (HR=0.95, p=0.66). The median overall survival in the devimistat and mFFX arm was 11.1 months, compared to 11.7 months in the FOLFIRINOX arm.
“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,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “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. I am also incredibly grateful to my team, who works tirelessly for the patients we treat.”
“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,” said Philip Philip, M.D., Ph.D., F.R.C.P, principal investigator and medical oncologist at the Karmanos Cancer Institute at Wayne State University. “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.”
Devimistat is also being evaluated in a Phase 3 study, ARMADA 2000, in patients with relapsed or refractory acute myeloid leukemia (AML). Following a prespecified interim analysis, the independent data monitoring committee has recommended that the trial be stopped due to lack of efficacy.
“Earlier clinical trial data demonstrated positive results, despite the challenges we face in treating AML,” said Jorge Cortes, M.D., director of the Georgia Cancer Center at Augusta University. “We were all hoping for positive results, and while this trial did not meet our expectations, we will continue to test devimistat in other studies.”
The company will work with investigators to complete a full evaluation of the data on both trials.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Neurocrine Biosciences (NBIX) Phase 3 KINECT-HD Study Evaluating Valbenazine for Chorea Associated with Huntington Disease Met Primary Endpoint
- Vir (VIR) and GlaxoSmithKline (GSK) Reports Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron Variant
- Study Shows 40-Fold Reduction in Neutralization Capacity of Pfizer (PFE) Vaccines Vs Omicron - DJ
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot FDA News
Related EntitiesDefinitive Agreement, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!