Exelixis' Cabozantinib Positive in Renal Cell Carcinoma Study

Exelixis, Inc. EXEL announced encouraging overall survival (OS) data from the phase III METEOR study on cabozantinib for the treatment of patients with advanced renal cell carcinoma (RCC).

The METEOR study is evaluating a tablet formulation of cabozantinib in comparison to Novartis AG’s NVS Afinitor (everolimus) in patients (n=658) with advanced RCC who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

Data from a second interim analysis demonstrated that patients who were randomized to receive cabozantinib showed a statistically significant and clinically meaningful increase in OS compared to those who received Afinitor. Data from the study are expected to be presented at a medical meeting later in 2016.

We remind investors that in Dec 2015, Exelixis completed the submission of a rolling New Drug Application in the U.S. for cabozantinib for the treatment of patients with advanced RCC who have received one prior therapy. A final decision on the approval status is expected on Jun 22, 2016. Cabozantinib is also under review in the EU for the same indication.

Cabozantinib has both Breakthrough Therapy designation and Fast Track status in the U.S. for the advanced RCC indication.

Meanwhile, Exelixis is also evaluating cabozantinib in the phase III CELESTIAL study for the treatment of patients with advanced hepatocellular carcinoma. Top-line results from the study are expected in 2017.

We note that Cometriq (cabozantinib) is currently approved in a capsule form in the U.S. for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). In the EU, it is approved for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.

Exelixis currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Celgene Corporation CELG and Ligand Pharmaceuticals Incorporated LGND, both sporting a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
 
CELGENE CORP (CELG): Free Stock Analysis Report
 
EXELIXIS INC (EXEL): Free Stock Analysis Report
 
LIGAND PHARMA-B (LGND): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research

Advertisement