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Exelixis, Inc. EXEL announced that the late-stage study, evaluating cabozantinib in patients suffering from radioiodine-refractory differentiated thyroid cancer who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies, met the co-primary endpoint of demonstrating significant improvement in progression-free survival.
The phase III trial, COSMIC-311, is a multicenter, randomized, double-blind, placebo-controlled study that aimed to enroll approximately 300 patients at 150 sites globally. Patients were randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily.
Data from this planned interim analysis of the phase III study, COSMIC-311, showed that cabozantinib reduced the risk of disease progression or death by 78% with a hazard ratio of 0.22.
The independent data monitoring committee for the study recommended stopping the enrollment and unblind sites and patients, given these results. Exelixis intends to discuss the study results, propose changes to the study conduct and plans for a regulatory filing with the FDA in the near term.
The safety profile was consistent with that previously observed for cabozantinib.
We remind investors that the tablet formulation of cabozantinib is approved as Cabometyx in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) and those with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Shares of Exelixis have increased 13.9% in the year so far compared with the industry’s growth of 11.2%.
In August 2020, Exelixis announced the submission of a supplemental new drug application (sNDA) to the FDA for cabozantinib in combination with Bristol-Myers’ BMY Opdivo for patients with advanced RCC. In October 2020, both companies announced that the FDA accepted Exelixis’ sNDA and Bristol-Myers’ supplemental biologics license application (sBLA), granted a Priority Review to both applications and assigned a target action date of Feb 20, 2021.
Exelixis has also collaborated with Roche RHHBY to evaluate Cabometyx in combination with the latter’s PD-L1 immune checkpoint inhibitor, Tecentriq, for various indications.
Exelixis currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the healthcare sector is Halozyme Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates have grown 22 cents for 2020 and 26 cents for 2021 in the past 60 days.
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