Shares Of Exelixis Surge Following Phase 3 Results Of Cabozantinib, Company Says EU Filing Planned For Early 2016

Shares of

surged higher by more than 7 percent at $5.90 early Tuesday morning after the company

positive results from its METEOR Phase 3 pivotal trial of cabozantinib. Exelixis' phase 3 pivotal trial involved 658 patients with renal cell carcinoma. The company said that cabozantinib treatment "resulted in benefits in progression-free survival (PFS)" and that "observed benefits were independent of the location and number of organ metastates, tumor burden, the type, duration and number of prior VEGF receptor TKI therapties, and prior PD-1/PD-L1 therapy." Exelixis stated that the data "further underscores clinical benefit of cabozantinib" and the data serves as the foundation for the US NDA (New Drug Application) submitted last month. The company added that an EU filing is planned for early 2016. "In the METEOR trial, cabozantinib was previously associated with statistically significant improvements in progression-free survival and objective response rate as compared to everolimus, a standard of care in the second-line renal cell carcinoma treatment setting," said Dr. Bernard Escudier, chair of the Genitourinary Oncology Committee at the Institut Gustave Roussy . "This latest data set demonstrates that these benefits are favorable across a variety of prespecified and post-hoc subgroups, including patients who have received prior therapy with immune checkpoint inhibitors. In addition, cabozantinib was active in patients with low and high tumor burden, including patients with both bone and visceral metastases. Collectively, the data from METEOR suggest that cabozantinib could become an important addition to the renal cell carcinoma treatment landscape if approved."