Cabozantinib Meets Primary Endpoint Of Progression Free Survival In Phase 3 Pivotal Trial In Medullary Thyroid Cancer

Exelixis, Inc. (NASDAQ:EXEL) today reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The trial, known as EXAM, met its primary endpoint of improving progression-free survival (PFS), with patients in the cabozantinib arm achieving a median PFS of 11.2 months compared with 4.0 months for patients in the placebo arm. Overall response rate (ORR), a secondary endpoint, was 28% in the cabozantinib arm and 0% in the placebo arm. Estimated PFS at one year was 47.3% with cabozantinib vs. only 7.2% with placebo. Data for overall survival (OS), another secondary endpoint, are not yet mature. Patients on the cabozantinib arm of the trial received a dose of 140 mg (free base equivalent). Adverse events were generally manageable allowing for treatment with cabozantinib for prolonged periods of time. Exelixis recently submitted a New Drug Application (NDA) for cabozantinib in MTC to the U.S. Food and Drug Administration (FDA).

Dr. Patrick Schöffski, professor at the Department of General Medical Oncology at the University Hospitals of Leuven, Catholic University Leuven, Belgium, presented the data (Abstract #5508) today in an oral session at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. The slides from the presentation are available at http://www.exelixis.com/resources/events/asco-2012.

“As the first phase 3 trial to enroll patients with independently confirmed radiographic progressing medullary thyroid cancer, EXAM represents an important milestone for this orphan disease in which there have been very few rigorous prospective clinical trials,” said Dr. Schöffski. “The data presented today are highly compelling and demonstrate that cabozantinib can provide a significant benefit to patients with advanced MTC. Taken as a whole, the results clearly show that cabozantinib is an important advance in the treatment of MTC and has the potential to improve the care and outcomes for MTC patients.”

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