Exelixis, Inc. (EXEL - Free Report) along with its French partner, Ipsen, announced the initiation of a pivotal phase III study — COSMIC-312 — to evaluate a Cabometyx (cabozantinib) combination therapy in treatment-naïve advanced hepatocellular carcinoma (“HCC”) patients, a form of liver cancer.
Moreover, an exploratory arm will also evaluate Cabometyx monotherapy in the first-line setting for similar patients.
Exelixis’ shares have lost 32.4% in a year compared with the industry’s decline of 16.8%.
The COSMIC-312 study will compare the combination of Cabometyx and Roche’s (RHHBY - Free Report) Tecentriq with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib) in previously untreated patients (n ≈ 640) with advanced HCC. The co-primary endpoints of the study are progression-free survival (“PFS”) and overall survival.
Per the press release, liver cancer is the second-highest cause of death among cancer patients. More than 800,000 new patients are diagnosed with liver cancer and the cause of death of more than 700,000 patients every year, globally. HCC is the most common form of liver cancer in the United States, which was diagnosed in almost 75% of 42,000 liver cancer patients in 2018. Moreover, patients with advanced HCC live less than six months without treatment.
Cabometyx is approved in first- or later-line setting for renal cell carcinoma (“RCC”), form of kidney cancer, in the United States. In May, the drug received approval for the first-line treatment of adults with intermediate- or poor-risk advanced RCC in Europe. The approval was based on Cabometyx’s superiority in improving PFS in advanced RCC patients over Pfizer’s (PFE - Free Report) Sutent.
Cabometyx is under review in the United States for previously treated advanced HCC patients. A decision is expected by mid-January 2019. In September, the Committee for Medicinal Products for Human has recommended the drug’s approval in Europe for a similar indication.
The drug enjoys orphan drug designation for advanced HCC in the United States, which means it will enjoy a seven-year exclusivity following its approval for the indication.
These label expansion efforts for Cabometyx bode well for the company as the drug is the major revenue generator for the company, contributing almost 70% to the company’s topline so far in 2018.
We remind investors that Exelixis entered into a collaboration and license agreement with Ipsen in February 2016 for the commercialization and further development of cabozantinib. Per the agreement, Ipsen received exclusive commercialization rights for current and potential future cabozantinib indications outside the United States, Canada and Japan.
Exelixis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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