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Exelixis (EXEL) Announces Final Results From HCC Study

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Exelixis, Inc. (EXEL - Free Report) announced results from the final analysis of the second primary endpoint of overall survival (OS) from the late-stage COSMIC-312 study.

COSMIC-312 is a global, multicenter, randomized, controlled phase III study that enrolled 837 patients at 281 study centers globally. The study evaluated Cabometyx (cabozantinib) in combination with Roche’s (RHHBY - Free Report) blockbuster immuno-oncology drug Tecentriq (atezolizumab) versus Nexavar in patients with previously untreated advanced hepatocellular carcinoma (HCC), the most common type of primary liver cancer.

Patients were randomized approximately 2:1:1 to one of three arms: Cabometyx (40 mg) in combination with Tecentriq (n=432), Nexavar (n=217) or Cabometyx (60 mg; n=188).

The results showed that the combination of Cabometxy, Tecentriq or Nevxavar did not improve OS nor worsened the same. Consequently, based on this outcome for OS and the rapidly evolving treatment landscape for previously untreated advanced HCC, Exelixis does not intend to submit a supplemental new drug application to the FDA.

We note that Cabometyx tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC) and for patients with HCC who have been previously treated with Nexavar.

It is also approved for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible.

Exelixis’ shares have lost 14.2% in the past year compared with the industry’s decline of 40%.

Exelixis to looking to expand Cabometyx’ label further.  The drug’s sales have shown a strong uptake following the approval of the drug in combination with Opdivo in 2021.

Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications. Roche’s Tecentriq is also approved for various oncology indications.

Exelixis is also looking to develop its portfolio beyond Cabometyx and has a strong pipeline.

EXEL currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Vertex Pharmaceuticals (VRTX - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vertex Pharmaceuticals’ earnings per share estimates have increased to $14.52 from $13.39 for 2022 over the past 60 days. Shares of VRTX have gained 12% in the past year.