| To: IRWIN JAMES FRANKEL who wrote (805) | 9/7/2011 3:54:26 PM |
| From: Ian@SI | Respond to of 892 |
| |
Per AF's comments, looks like good MTC results are imminent...
Exelixis Reaches Pre-Specified Number of Events for Final Data Analysis in EXAM Trial
bwire
SOUTH SAN FRANCISCO, Calif. (Business Wire) -- Exelixis, Inc. (Nasdaq: EXEL) today announced that the pre-specified
number of progression-free survival (PFS) events required for
un-blinding of the data for the ongoing phase 3 pivotal trial of
cabozantinib in patients with medullary thyroid cancer (MTC), known as
the EXAM trial, has been reached. Final data analysis in preparation for
un-blinding is underway, and the company expects to report top-line data
early in the fourth quarter of 2011.
"We are pleased to have reached this important milestone in the EXAM
trial and to now be finalizing our internal work to report top-line
results of this important phase 3 trial for Exelixis," said Michael
Morrissey, president and chief executive office of Exelixis. "We view
MTC as the first building block in the cabozantinib franchise, which we
expect to complement with the planned initiation of our pivotal trial in
castration-resistant prostate cancer later this year."
EXAM Trial Design
EXAM is an international, randomized, placebo-controlled, double-blinded
study of cabozantinib in patients with unresectable, locally advanced,
or metastatic MTC. Patients with documented progressive disease were
randomized in a 2:1 ratio to receive cabozantinib or placebo
administered at a daily dose of 175 mg. The study does not allow for
cross-over from the placebo arm to cabozantinib. With an enrollment
target of 315 patients and a planned event-driven analysis, the trial
provides 90% power to detect a 75% increase in progression-free
survival, the primary endpoint of the study. Additionally, the study is
designed to assess overall survival at a later time point once those
events have been achieved, and is powered to detect a 50% improvement in
survival compared with placebo. Exelixis is conducting this trial under
a Special Protocol Assessment from the FDA, which allows for full
approval on the basis of PFS if the data are supportive. EXAM completed
enrollment in the first quarter of 2011. |
