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Exelixis' (EXEL) Cabozantinib Combo Study Fails to Meet Goal

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Shares of Exelixis, Inc. (EXEL - Free Report) were down 0.17% on Mar 3 after the company announced the failure of the late-stage CONTACT-03 study.

CONTACT-03 evaluated Cabometyx (cabozantinib) in combination with Roche’s (RHHBY - Free Report) Tecentriq (atezolizumab) versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) renal cell carcinoma (RCC) who progressed during or after immune checkpoint inhibitor therapy (either combination or monotherapy). RCC is a type of kidney cancer.

Patients were randomized 1:1 between the experimental arm of cabozantinib in combination with atezolizumab and the control arm of cabozantinib alone.

The CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS).

The company has collaborated with Roche to evaluate the combinaton of cabozantnib and Roche’s Tecentriq, broadening its exploration of cabozantnib combinatons with immune checkpoint inhibitors (ICIs). Tecentriq is an ICI. CONTACT-03 is sponsored by Roche and co-funded by Exelixis.

Cabometyx (cabozantinib) is approved for advanced RCC and previously treated hepatocellular carcinoma (HCC).

In January 2021, the FDA approved Cabometyx in combination with Bristol-Myers’ (BMY - Free Report) immuno-oncology drug Opdivo for the first-line treatment of patients with advanced RCC. This approval has significantly boosted sales.

Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.

Exelixis’ shares have lost 18.7% in the past year compared with the industry’s decline of 5.6%.

 

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The setback is disappointing as Exelixis is working on expanding cabozantinib’s label further. The company is currently evaluating cabozantinib, both as a single agent and in combination with ICIs, in a broad development program and the successful development of the same will propel sales further.

Exelixis’ fourth-quarter results were decent. Demand continues to grow based on sales volume being driven by the Cabometyx and Opdivo combination. Per the company, Cabometyx maintained its status as the leading TKI for RCC in both the first-line I/O-TKI market and the second-line monotherapy segment.

Exelixis is striving hard to develop its portfolio beyond Cabometyx and has progressed three promising biotherapeutics, XB010, XB014 and XB628, from internal discovery into preclinical development.

Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.



 


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