Results from the CheckMate-016 study to investigate a combination of nivolumab and ipilimumab in people with advanced renal cell carcinoma (RCC) were presented at the European Society for Medical Oncology (ESMO) meeting in Copenhagen over the weekend.
The results show that 40% of patients treated with the nivolumab/ipilimumab combination experienced a significant reduction in the size of their tumours, and in 10% of these patients the cancer appeared to have disappeared; there was no detectable sign of disease.
Although these results are very exciting, CheckMate-016 was an early phase I trial, chiefly designed to find the safest dose of the nivolumab/ipilimumab combination to give to RCC patients, and to look at the safety and tolerability of this combination of drugs. Response rates were secondary outcome measures in the trial, since the trial did not include enough patients to be able to assess efficacy effectively.
The small number of patients needs to be taken into account when looking at the efficacy results, and the data needs to be treated with caution until more patients have received this combination. A phase III randomised controlled clinical trial is underway to collect more information about the efficacy of the nivolumab/ipilimumab combination in people with advanced RCC.
The researchers said “The results from CheckMate-016 are encouraging, and warrant further study, as they show with nearly two years of follow-up, 40.4% of patients in each nivolumab plus ipilimumab combination arm responded to the regimen, with the majority of responses occurring early and within the first few months of treatment.”
The nivolumab/ipilimumab combination of drugs has already been approved for NHS patients with advanced melanoma skin cancer.