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Exelixis (EXEL) Down on Data from Ongoing Liver Cancer Study

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Shares of Exelixis, Inc. (EXEL - Free Report) were down 23% after it announced disappointing data from the ongoing phase III study, COSMIC-312.

The study is evaluating Cabometyx in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) as compared to Nexavar (sorafenib) in patients with previously untreated advanced hepatocellular carcinoma (HCC), a type of liver cancer. 

While Exelixis is sponsoring COSMIC-312, partner Ipsen is co-funding the trial. Patients were randomized approximately 2:1:1 to one of the three arms — Cabometyx (cabozantinib 40 mg) in combination with Tecentriq, Nexavar, or Cabometyx (60 mg).

Data from the study showed that it met only one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis. Cabometyx in combination with Tecentriq significantly reduced the risk of disease progression or death by 37% as compared to Nexavar in the analysis of the primary endpoint of PFS.

However, a prespecified interim analysis for the second primary endpoint of overall survival (OS) did not reach statistical significance.

Hence, based on these preliminary OS data, Exelixis anticipates the probability of reaching statistical significance at the time of the final analysis to be low.

Nevertheless, the study will continue as planned to the final analysis of OS and results are expected in early 2022. Exelixis also plans to discuss the trial results and next steps for a potential regulatory filing with the FDA.

The company’s shares have lost 9.9% in the year so far compared with the industry’s gain of 0.9%.

 

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

In January 2021, Exelixis obtained the FDA approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Bristol Myers’ (BMY - Free Report) Opdivo as a first-line treatment of patients with advanced RCC. Subsequently, in March 2021, Exelixis’ partner Ipsen received approval from the European Commission for this combination as a first-line treatment for advanced RCC.

While this market represents huge potential, competition is stiff from the recently-approved combination therapies.

Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Repligen Corp. (RGEN - Free Report) , which presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days. The stock price has increased 6.6% in the year so far.

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