On September 7, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients (Press release, Bristol-Myers Squibb, SEP 7, 2017, View Source [SID1234520402]). The combination also met a secondary endpoint of improved OS versus sunitinib in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early.
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"This overall survival result from CheckMate -214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need," said Vicki Goodman, M.D., head of new asset development, Bristol-Myers Squibb. "The company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress presentation later this week."
The safety and tolerability of the Opdivo plus Yervoy combination observed in CheckMate -214 was consistent with previous reports of this dosing schedule and similar across subgroups.
About CheckMate -214
CheckMate -214 is a phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma. Patients in the combination group received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks. Patients in the comparator group received sunitinib 50 mg once daily for 4 weeks, followed by 2 weeks off before continuation of treatment. Patients were treated until progression or unacceptable toxic effects. The primary endpoints of the trial are progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) in an intermediate to poor-risk patient population (approximately 75% of patients). The majority of alpha was allocated to overall survival. Safety is a secondary endpoint.
As previously reported, the combination of Opdivo plus Yervoy achieved an ORR of 41.6% versus 26.5% for sunitinib in poor- and intermediate-risk patients, a co-primary endpoint. Median duration of response was not reached for the combination and was 18.2 months for sunitinib. PFS in the intermediate- and poor-risk patients, a co-primary endpoint, improved 18% for those receiving the combination, [HR=0.82, (99.1% CI: 0.64 to 1.050); stratified two-sided (p=0.0331)], but did not reach the pre-defined statistical significance threshold of 0.009 compared to sunitinib. The median PFS for the combination group was 11.6 months (95% CI: 8.71 to 15.51) versus 8.4 months (95% CI: 7.0 to 10.8) for the sunitinib group.
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all cases. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the five-year survival rate for those diagnosed with metastatic, or advanced kidney cancer, is 12.1%.