Exelixis, Inc. (NASDAQ:EXEL) announced that the FDA approved Cabometyx (cabozantinib) tablets for treatment of hepatocellular carcinoma (HCC) — an aggressive form of liver cancer — in patients who have been previously treated with Bayer’s (OTC:BAYRY) Nexavar (sorafenib). Shares of the company rose about 5% on Jan 15, following the news announcement. Share price of Exelixis has increased 8.5% in the past year, against the industry’s decline of 15.4%.
The approval was supported by results from the phase III CELESTIAL study on Cabometyx for patients with advanced HCC, having previously received Nexavar and may have undergone up to two prior systemic cancer therapies for HCC along with showing adequate liver function. The study met its primary endpoint of overall survival (OS). Cabometyx showed a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. In the study, OS was 10.2 months in the cabozantinib arm compared with 8 months in the placebo arm.
We remind investors that in November 2018, Exelixis’ partner received Ipsen received approval from the European Commission for the same indication.
Cabometyx is presently marketed in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. It is also approved in Europe for the first-line treatment of adults with intermediate- or poor-risk advanced RCC. Per the press release, liver cancer is the leading cause of death among cancer patients. More than 800,000 new patients are diagnosed with liver cancer, which is 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.
We also remind investors that Exelixis along with Ipsen announced the initiation of a pivotal phase III study — COSMIC-312 — to evaluate a Cabometyx combination therapy in treatment-naïve advanced HCC patients. The COSMIC-312 study will compare the combination of Cabometyx and Roche’s (OTC:RHHBY) Tecentriq with Nexavar in previously untreated patients suffering from advanced HCC. The co-primary endpoints of the study are progression-free survival (“PFS”) and OS.
Separately, Exelixis has also initiated a phase Ib study (investigator-sponsored) on cabozantinib (in combination with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab) or Opdivo plus Yervoy) in patients suffering from genitourinary tumors, including bladder cancer and RCC.
These label expansion efforts for Cabometyx bode well for the company as the drug is the major revenue generator for the company.
Zacks Rank
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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