Five Prime Therapeutics Inc (NASDAQ: FPRX) is rocketing in the market this morning, trading on gains that are better stated in multiples than percentages after the company announced positive topline results from a Phase 2 clinical trial. Of course, the results were promising. Here’s what’s going on:
FPRX Stock Rockets On Clinical Data
In the press release, Five Prime Therapeutics announced top line results from the Phase 2 FIGHT Trial. During the trial, the company company assessed its candidate, bemarituzumab in combination with chemotherapy in patients with advanced forms of gastric or gastroesophageal junction (GEJ) cancer.
In the release, FPRX announced that all three efficacy endpoints were met. These included improvements in progression free survival (PFS), overall survival (OS), and overall response rate (ORR). Moreover, all grade adverse events were comparable in the treament and control arms of the study as was the case with serious adverse events and death due to adverse events.
While adverse events were comparable to the control arm, the company did say that there were a higher frequency of discontinuation of bemarituzumab compared to placebo. Nonetheless, the company said that the overall results serve to validate the importance of the novel target, FGFR2b.
FPRX said that it plans to complete a full evaluation of the Phase 2 clinical data and work with investigators to share the results at upcoming medical conferences.
In a statement, Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program, and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, had the following to offer:
We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies. This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab’s potential benefit is an important and exciting development.”
The above statement was followed up by Helen Collins, M.D., Executive Vice President and Chief Medical Officer at FPRX. Here’s what she had to offer:
These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade. Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+. Five Prime is grateful to the patients and investigators who participated in our clinical trials, and we look forward to discussing next steps with health authorities worldwide.
This News Is Huge
If all continues to go well with bemarituzumab, Five Prime Therapeutics could be sitting on a blockbuster therapy. While FGFR2b has been overexpressed in gastrointestinal cancers, it is also overexpressed in other cancers. These include squamous non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer, and intrahepatic cholangiocarcinoma.
Should the results continue to be positive in gastrointestinal cancers, it will open the door not only to a potentially compelling revenue stream, but several other opportunities in other indications. As a result, bemarituzumab could quickly become a multi-billion dollar evenue generator. Not too shabby for a comapny with a market cap of around $200 million. No wonder investors are so excited.
All in all, FPRX stock should be on your watch list!
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