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    RCC: Two approvals expand options for TKI-refractory patients


    The approval of cabozantinib was based on results from the phase III METEOR trial of subjects with advanced kidney cancer, in which treatment with cabozantinib tablets resulted in improved overall survival, progression-free survival, and objective response rate. In that study, which was published in the New England Journal of Medicine (2015; 373:1814-23), those randomized to cabozantinib, 60 mg daily, had a median progression-free survival of 7.4 months versus 3.8 months in a group of patients who received everolimus, 10 mg daily. Rate of progression or death was 42% lower in the cabozantinib group than with everolimus. Objective response was 21% with cabozantinib versus 5% with everolimus.

    Read: What anti-PD-L1 immunotherapy approval means for urology

    Exelixis announced in February 2016 that cabozantinib demonstrated, in that same trial, a 34% reduction in the rate of death compared to everolimus.

    Toni Choueiri, MDDr. Choueiri“The efficacy profile demonstrated by CABOMETYX in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” said Toni Choueiri, MD, of Dana-Farber Cancer Institute, Boston in a press release from Exelixis. “CABOMETYX is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL, and three VEGF receptors.

    “The approval of CABOMETYX is wonderful news for physicians who are looking for a new option for their previously treated patients with advanced kidney cancer.”

    The most common adverse reactions (frequency ≥25%) in cabozantinib-treated patients include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation. Dose reduction rates were 60% for CABOMETYX and 24% for everolimus. The treatment discontinuation rate was 10% in both the cabozantinib and everolimus arms of the trial. Rates of severe hemorrhage, gastrointestinal perforations and fistulas, thrombotic events, and hypertension and hypertensive crisis were higher with cabozantinib than with everolimus.

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    More recently, METEOR subgroup analyses presented at the American Society of Clinical Oncology annual meeting in Chicago demonstrated that cabozantinib’s benefits in progression-free survival and overall survival were independent of the presence of bone metastases, prior anti-PD-1/PD-L1 therapy, and the type of prior VEGF receptor TKI therapy, according to a separate press release from Exelixis.

    Next: Read more about lenvatinib

    Lisette Hilton
    Lisette Hilton, president of Words Come Alive, has written about health care, the science and business of medicine, fitness and wellness ...


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