|Exelixis, Inc. Jumps 51% On Meteroric METEOR Results|
|By David Fowler|
|Monday, 20 July 2015 14:44|
Exelixis, Inc. (NASDAQ:EXEL) has confirmed positive top-line results resulting out of initial analysis of METEOR, phase 3 pivotal trial that compares cabozantinib to everolimus in more than 658 patients suffering from metastatic renal cell carcinoma.
The trial achieved the first objective of showing initial result of a significant rise in progression-free survival in the first 375 randomized patients. Cabozantinib lowered risk of disease progression by 42 percent vis-a-vis everolimus arm.
Data related to survival in the study of 658 patients included secondary endpoint of trial. METEOR’s initial analysis had review of serious adverse event (SAE) data. Depending on the analysis, the number of SAEs of any Grade no matter the causality was approximately balanced between study arms. The rate of treatment discontinuation because of bad events was less in 10% in both study arms.
In April 2015, cabozantinib had got Fast Track designation by U.S. Food and Drug Administration for potential treatment of advanced RCC patients having got one prior therapy. Depending on the result, Exelixis aims to finish regulatory filings in United States as well as European Union in early 2016.
Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator, opined that the firm is keen to offer fresh treatment options for patients having metastatic RCC especially in the second-line setting. He added that the size of improvement in PFS observed with cabozantinib was as good as everolimus in METEOR trial.
Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, opined that good top-line results from METEOR show strong progress for kidney cancer community as well as Exelixis leading to a step nearer to the aim of delivering a meaningful differentiated therapeutic option for many metastatic RCC patients in need.
Dr. Morrissey added that giving top-line results for METEOR is a part of clinical development as well as regulatory milestones that has been planned for the year.
Shares of the company are up 51% to $5.91.