Exelixis says late-stage study of Cometriq in metastatic renal cell carcinoma hits main goal

Exelixis announced Monday that a Phase III study of Cometriq (cabozantinib) in patients with metastatic renal cell carcinoma (RCC) who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor met its main goal of progression-free survival (PFS), sending the drugmaker's shares up as much as 47 percent. "With these data now in hand, Exelixis' highest corporate priority becomes the submission of US and EU regulatory filings, which we intend to complete in early 2016," commented CEO Michael Morrissey.

The METEOR trial randomised 658 patients to receive either Cometriq or Novartis' Afinitor (everolimus), with the initial analysis conducted among the first 375 subjects. In addition to the primary endpoint of PFS, secondary endpoints included overall survival (OS) and the overall response rate.

Top-line results demonstrated that Cometriq significantly increased PFS as determined by an independent radiology committee, with the drug cutting the risk of disease progression or death by 42 percent compared to Afinitor. In addition, Exelixis noted that although OS data were immature at the data cut-off, results indicated a trend favouring Cometriq. Further, the company stated that although significance was not reached for the OS endpoint at the time of the interim analysis, the trial will continue to the final survival analysis, which is anticipated in 2016.

Exelixis noted that the incidence of serious adverse events of any grade was "approximately balanced" across the study arms, while the treatment discontinuation rate was similar between the groups. The company added that detailed results will be submitted for presentation at an upcoming medical conference. Last September, Exelixis announced plans to reduce its workforce by up to 70 percent following the failure of the late-stage COMET-1 trial testing Cometriq in men with metastatic castration-resistant prostate cancer.

Cometriq was granted fast-track designation by the FDA in April for the treatment of advanced RCC. The therapy, which has been cleared in the US for progressive metastatic medullary thyroid cancer (MTC) and conditionally approved in Europe to treat adults with progressive, unresectable locally advanced or metastatic MTC, generated $25 million in revenue last year.

In related news, Bristol-Myers Squibb said Monday that its PD-1 inhibitor Opdivo (nivolumab) also yielded positive results in patients with RCC versus Afinitor. Specifically, the company reported that the Phase III CheckMate -025 study of Opdivo was stopped early after an independent data monitoring committee concluded the trial had met the primary OS endpoint in previously-treated patients with advanced or metastatic RCC. Analysts estimate that Novartis generates roughly $400 million from Afinitor in the kidney cancer indication.

For further analysis, see ViewPoints: Exelixis finds redemption for Cometriq in kidney cancer study but sees celebration cut short by new Opdivo data.

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