Embattled Exelixis Nabs Much-Needed Victory for Phase III Renal Cell Carcinoma Study

Published: Jul 21, 2015

Embattled Exelixis Nabs Much-Needed Victory For Phase III Renal Cell Carcinoma Study
July 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff

South San Francisco, Calif.-based Exelixis, Inc. announced today that its Phase III clinical METEOR trial comparing Cometriq (cabozantinib) to everolimus in metastatic renal cell carcinoma had positive topline results.

The drug showed a statistically significant increase in progression-free survival (PFS) in the first 375 patients and reduced the risk of death or disease progression by 42 percent. Data is still being analyzed on the full study population of 658. Final analysis is expected in 2016.

“The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningful differentiated therapeutic option for the many metastatic RCC patients in need,” said Michael Morrissey, Exelixis’ president and chief executive officer in a statement. “With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016.”

Last year, in September 2014, the company hit a major speed bump when it announced Cometriq, for advanced prostate cancer that had metastasized to the bone, did not extend survival. Company stock dropped 48 percent at the news.

The drug was approved for medullary thyroid cancer, which is fairly rare. In 2014, Cometriq brought in about $25 million.

Patients being treated for kidney cancer are typically given Sutent (Pfizer Inc. or Votrient (GlaxoSmithKline . If those drugs don’t work, patients are given Afinitor (Novartis AG or Inlyta (Pfizer).

The new trial compared Cometriq to Afinitor. Patients receiving Cometriq were 42 percent less likely to die or have their cancer get worse than patients receiving Afinitor.

If the drug is approved for kidney cancer, it could generate several hundred million dollars in sales. Analysts believe that Novartis’ Afinitor brings in about $400 million for kidney cancer.

Exelixis announced on June 1 that the same drug had shown positive results in a Phase II clinical trial for EGFR wild-type non-small cell lung cancer (NSCLC). The drug met its primary endpoint, showing significant increases in progression-free survival (PFS) for cabazantinib and the combination of cabozantinib and erlotinib compared to the patients receiving only erlotinib.

“Obviously this is the first step for us in the second-line population with single-agent cabozantinib, and we’re very interested in moving both up in line of therapy as well as in terms of combinations,” said Morrissey in today’s web conference “That takes a lot of data to be able to navigate that evolution to be able to understand where a drug like cabozantinib could fit. Certainly having a foundation of this kind of positive Phase III data with a clear win PFFs, strong trend in overall survival and good tolerability allows us to ask those key questions about how we combine and how we move forward in terms of looking at both second-line and also first-line with the appropriate comparators and combination partners.”

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