Exelixis (EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) announced the initiation of COSMIC-312. A phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) versus sorafenib, in previously untreated advanced hepatocellular carcinoma (HCC). The co-primary endpoints of the trial are: progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting.
COSMIC-312 is a multicenter, randomized, controlled phase 3 pivotal trial that aims to enroll approximately 640 patients at up to 200 sites globally. Patients will be randomized 6:3:1 to one of three arms: cabozantinib (40 mg) and atezolizumab, sorafenib, or cabozantinib (60 mg).
Prohost observations on this news are several.
To begin with, we observed the transformation of the relationship between Exelixis and Ipsen. Ipsen transformed from a mere marketer for Exelixis products outside the United States, into a giant firm interested in Exelixis future plans. Ipsen showed interest in the Phase 3 trial of Cabozantinib in previously untreated liver cancer. Although Exelixis is the sponsor of the trial Ipsen has become more than just a potential marketer but a partner as it is co-funding the trial that would support potential future regulatory submissions outside of the U.S. and Japan.
Another observation is that Genentech – a member of the Roche Group – has provided Roche’s group product TECENTRIQ®, for use in this trial.
Both the above observations point to the confidence in the capability of cabozantinib (CABOMETYX®) to become the first line of treatment in previously untreated liver cancer.
Another observation is the huge market for liver cancer. There is more than 800,000 new liver cancer diagnosed each year worldwide. There is a poor prognosis for patients with advanced disease, making it urgent to bring to the clinic new treatment options. That’s what R. Kate Kelley, M.D., Associate Professor of Clinical Medicine, Division of Hematology/Oncology, University of California, San Francisco and lead investigator on COSMIC-312, stated and added, “We look forward to learning whether the combination of cabozantinib and atezolizumab may improve outcomes for previously untreated patients.”
There is no doubt that Exelixis is growing the market of its approved products especially cabozantinib.
Exelixis is advancing its experience in discovering, optimizing and developing candidates for cancer treatment. As we know, the firm has assembled a small molecule chemical compound library consisting of over four million discrete drug leads, which maximizes the firm’s chances of identifying starting points for drug optimization against a wide variety of targets. The optimized drug candidates are to be extensively tested for anti-cancer activity, alone and in combination with other therapies, in laboratory tumor models and, as the firm stated, picking only the molecules that meet rigorous standards of activity and safety to advance into the clinic.
We expect to see an increase in these molecules in the future.