Exelixis, Inc. EXEL announced the initiation of CONTACT-03, a global phase III pivotal study of Cabometyx (cabozantinib) in combination with Roche AG’s RHHBY Tecentriq (atezolizumab). The study will be conducted in patients with inoperable, locally advanced or metastatic renal cell carcinoma (RCC), who progressed during or following the treatment with an immune checkpoint inhibitor as the immediate preceding therapy.
About 500 patients are expected to be enrolled in the study. In the study, the patients will be randomized 1:1 to the experimental arm of Cabometyx in combination with Tecentriq or the control arm of Cabometyxalone. The co-primary endpoints of the study are progression-free survival per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1, as assessed by independent review, and overall survival. Secondary endpoints include progression-free survival, objective response rate and duration of response, as assessed by the investigators.
The CONTACT-03 study is sponsored by Roche and co-funded by Exelixis. The study is the third of the three phase III pivotal studies that are part of a clinical collaboration with Roche. The other two studies are CONTACT-01 and CONTACT-02. The CONTACT-01 study deals with patients with metastatic non-small cell lung cancer (NSCLC), who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy. CONTACT-02 focuses on patients with metastatic castration-resistant prostate cancer (CRPC), who have been previously treated with one novel hormonal therapy. Both these studies were initiated in June 2020.
Cabometyx tablets are already approved in the United States for the treatment of advanced RCC and hepatocellular carcinoma (HCC), who have been previously treated with Bayer’s BAYRY Nexavar.
The company’s shares have surged 45.3% year to date compared with the industry’s growth of 12.6%.
However, competition is stiff from the recently approved combination therapies for RCC. The FDA has approved Merck’s MRK Keytruda in combination with Inlyta for the first-line treatment of patients with advanced RCC.
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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