It’s a black day at OncoMed $OMED. A little more than a year after its number two drug foundered in a Phase II failure, its top drug demcizumab — partnered with Celgene in a multibillion-dollar deal — has flopped in a Phase II as well. And the biotech followed up with the news that Bayer is bypassing a tie-up on two other key programs, completing a one-two punch.
The mid-stage study of demcizumab was an embarrassing failure for the primary as well as the key secondary endpoint in the study of metastatic pancreatic cancer — a tough field in cancer R&D. Combining demcizumab with Abraxane and gemcitabine in untreated patients essentially mirrored the PFS results for the comparative triple that replaced OncoMed’s drug with a placebo.
The median overall survival rate in the demcizumab arm, meanwhile, hit 13.2 months, while the placebo group hasn’t yet reached a median OS rate. The overall response rate was 33.1% in the drug triple, compared to 41.2% in the comparator arm.
“Based on the lack of benefit over standard-of-care, which performed remarkably well, we will be discontinuing this trial. We will conduct additional analyses, together with our partner, Celgene, to understand these outcomes. We will also discontinue any additional enrollment in our other ongoing demcizumab trials and conduct analyses of the data from those trials as planned,” said OncoMed CEO Paul J. Hastings.
Celgene paid $177 million up front and promised more than $3 billion in milestones to gain co-marketing rights to demcizumab in 2013. That deal helped establish OncoMed as a biotech to watch, with a spotlight on their lead cancer stem cell therapy.
Bayer Pharma added injury to insult today, notifying OncoMed that it decided not to exercise its option on the biotech’s Wnt pathway inhibitors vantictumab (anti-Fzd, OMP-18R5) and ipafricept (Fzd8-Fc, OMP-54F28) for “strategic reasons.”
The Redwood City, CA-based biotech’s near term hopes now rest on two other Phase II studies, PINNACLE and DENALI, that are due to read out later in this quarter.
“Pancreatic cancer has proven to be a uniquely challenging disease, and these data appear to reflect some of those disease and treatment complexities. The safety data seen in the YOSEMITE trial were generally consistent and in line with our expectations. We continue to analyze these data, and look forward to presenting the full study findings at a future scientific congress,” said Robert Stagg, Senior Vice President of Clinical Research and Development.
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