A new cooperative research study including Norris Cotton Cancer Center's Lionel Lewis, MB BCh, MD, finds that nivolumab plus ipilimumab therapy demonstrated manageable safety, notable antitumor activity, and durable responses with promising long term overall survival in patients with metastatic renal cell cancer (mRCC). The multi-institutional study known as the CheckMate 016 study evaluated the efficacy and safety of nivolumab plus ipilimumab in combination and found that the combination treatment showed enhanced antitumor activity compared with monotherapy in tumor types such as melanoma.

Renal cell carcinoma accounts for 2.4% of total cancer cases worldwide, with 338,000 patients diagnosed each year. More than one quarter of these patients present with metastatic disease associated with high mortality. Current treatment options are quite limited, and toxic side effects make them difficult for patients to withstand. Newer immunotherapies such as immune checkpoint inhibitors nivolumab and ipilimumab have demonstrated better response rates and tolerability through different but complementary mechanisms of action. The combination of these agents has previously been shown to achieve better responses compared with either drug alone in patients with metastatic melanoma and lung cancer, which suggested to researchers that the same may be true for this combination across various tumor types, including mRCC.

"New immunotherapies are showing great promise and novel combinations of these produce more effective treatments than the two used separately," said Lewis. "In this study our results show the combination to be highly effective with durable tumor effects that turn into a longer life for patients with kidney cancer that has spread." The team's findings, "Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study" have recently been published in Journal of Clinical Oncology.

Next steps include further follow up of patients on this study and a larger Phase III study of nivolumab plus ipilimumab in combination in mRCC and other solid tumors.

Hammers HJ, Plimack ER, Infante JR, Rini BI, McDermott DF, Lewis LD, Voss MH, Sharma P, Pal SK, Razak ARA, Kollmannsberger C, Heng DYC, Spratlin J, McHenry MB, Amin A.
Safety and Efficacy of Nivolumab in Combination With Ipilimumab in Metastatic Renal Cell Carcinoma: The CheckMate 016 Study.
J Clin Oncol. 2017 Jul 5:JCO2016721985. doi: 10.1200/JCO.2016.72.1985.