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    Oral agent improves survival in advanced RCC patients

    Phase III data on new TKI show marked benefit in patients with bone metastases

     

    Benefit regardless of MET expression

    Among patients with high, low, and unknown tumor MET status, cabozantinib reduced the risk of death by 45%, 28%, and 33%, respectively, compared with everolimus.

    “These data suggest patients experience benefit with cabozantinib regardless of MET expression and could reflect the broader target profile of cabozantinib,” Dr. Choueiri said.

    PFS results based on data from all 658 randomized patients were consistent with the results of the primary endpoint analysis that was conducted based on data from the first 375 patients treated and also highly consistent with the OS benefits, Dr. Choueiri said.

    Related - Sunitinib vs. everolimus: PFS, toxicity differ in study

    In the primary endpoint analysis, median PFS was 7.4 months for cabozantinib and 3.8 months for everolimus, and cabozantinib reduced the rate of disease progression or death by 42%. In the secondary analysis based on all 658 patients, median PFS was 7.4 months for cabozantinib and 3.8 months for everolimus, and cabozantinib reduced the rate of disease progression or death by 49% (p<.0001).

    The objective response rate based on independent radiology review was 17% for cabozantinib compared with 3% for everolimus (p<.0001).

    Findings of the updated safety analysis for both treatments were similar to those previously reported at the time of the primary endpoint analysis of PFS.

    “Treatment-emergent adverse events were effectively managed with dose modifications in both arms, and so the discontinuation rate due to adverse events was low in both treatment groups,” Dr. Choueiri said.

    Dr. Choueiri is a consultant/adviser for Bayer, Bristol-Myers Squibb, Eisai, Foundation Medicine, GlaxoSmithKline, Merck, Novartis, Pfizer, Prometheus, and Roche/Genentech. His institution has received research funding from a number of pharmaceutical companies. Several of Dr. Choueiri’s co-authors have a financial or other relationship with Exelixis, Novartis, Pfizer, and/or other pharmaceutical companies.

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