Exelixis announces breakthrough results from kidney cancer study assessing COMETRIQ®

WASHINGTON - July 21, 2015 - PRLog -- Exelixis, Inc. has announced positive top line results from METEOR, the pivotal phase 3 trial evaluating COMETRIQ® (cabozantinib) in comparison to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

The METEOR study revealed that COMETRIQ® reduced the risk of disease progression or death by 42 percent in comparison to the everolimus arm (hazard ratio [HR]=0.58, 95 percent CI 0.45-0.75, p<0.0001). The trial was successful in meeting its endpoint based on the increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC).  According to Exelixis, a prespecified interim analysis stimulated by the principal analysis of the PFS exemplified a trend in overall survival (OS) favoring COMETRIQ®.

“The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need,” said Michael M. Morrissey, Ph.D., the company’s president and chief executive officer.

Dr. Morrissey continued, “Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible.”

Cabozantinib received Fast Track designation by the U.S. Food and Drug Administration (FDA) in April 2015 based on its potential to treat advanced RCC patients who have received one prior therapy. Exelixis is expected to submit U.S. regulatory filings for this indication in early 2016.

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