Exelixis Posts Positive Late Stage Results in METEOR trial

Exelixis Inc. (NASDAQ: EXEL) was up slightly in Tuesday’s trading session following positive results from a late stage trial. The company announced the presentation of positive data from subgroup analyses of METEOR, the Phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

The METEOR trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) for cabozantinib as compared to everolimus, as determined by an independent radiology committee.

The cabozantinib treatment resulted in benefits in PFS the trial’s primary endpoint, and objective response rate, a secondary endpoint, across various prespecified and post-hoc analysis subgroups. Importantly, observed benefits were independent of the location and number of organ metastases, tumor burden, the type, duration and number of prior VEGF receptor TKI therapies, and prior PD-1/PD-L1 therapy.

Bernard Escudier, M.D., chair of the Genitourinary Oncology Committee at the Institut Gustave Roussy (Villejuif, France) and an investigator on the METEOR trial, commented:

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. 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.

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Michael M. Morrissey, Ph.D., president and CEO of Exelixis, added:

These data were included in our New Drug Application with the U.S. Food and Drug Administration, filed last month, and we intend to include them in our upcoming European Union Marketing Authorization Application, which we expect to submit shortly. Additionally, in 2016 we await the final analysis for METEOR’s overall survival secondary endpoint.

Shares of Exelixis were trading at $5.43 on Tuesday, with a consensus analyst price target of $6.00 and a 52-week trading range of $1.56 to $6.81.