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The COSMIC-313 study previously showed improved survival when combining cabozantinib with two immunotherapy medicines, nivolumab and ipilimumab for patients with advanced clear cell kidney cancer. This combination of three anti-cancer medicines is being looked at in patients with advanced non-clear cell kidney cancer in a different phase 2 study. This phase 2 study was presented at the American Society of Clinical Oncology (ASCO) Annual meeting in Chicago, USA this week.
40 patients were recruited for this study. Most patients had papillary (19), chromophobe (11) or translocation (5) kidney cancer. 1 in 10 patients had received previous treatment with targeted therapy, excluding cabozantinib and immunotherapy.
Since the study is still ongoing the patients are at various stages of their treatment schedule. At the time the results were looked at, 38 patients had started treatment and nearly half of them had received all four doses of ipilimumab and were continuing with nivolumab and cabozantinib. More than 80% of patients needed a reduction in their dose of cabozantinib from 40 mg/day to 20 mg/day or every other day.
Patients were followed for an average of 8.4 months. Eight (8) patients responded to treatment and this response lasted for at least 6 months. The average time to when the treatment stopped working and the cancer started growing again was nearly 9 months.
Three quarters of patients had serious or life-threatening side effects to treatment. More than a third of patients reported liver damage and 29% of patients had side effects that needed treatment with high dose steroids. 13% of patients stopped treatment because of side effects. There were no deaths.
This study shows a clinically meaningful benefit for the triple combination of nivolumab, ipilimumab and cabozantinib improved survival in patients with non-clear cell kidney cancer, particularly chromophobe kidney cancer. However, the trial is ongoing, and a further 20 patients are being recruited and treated with a lower starting dose of cabozantinib (20 mg/day).