PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

“There remains a high unmet medical need for patients with advanced renal cell carcinoma,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We are encouraged by today’s positive opinion from the CHMP and look forward to potentially bringing the first Immuno-Oncology combination therapy to appropriate RCC patients across the EU.”

The CHMP recommendation is based on positive data from the Phase 3 CheckMate -214 clinical trial, which was stopped early following a planned interim analysis that showed the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg demonstrated a significant increase in overall survival (OS) with a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of PD-L1 expression level, compared to a current standard of care, sunitinib (Hazard Ratio [HR] 0.63; 99.8% Confidence Interval [CI]: 0.44 to 0.89; p<0.0001). Median OS in patients treated with Opdivo plus low-dose Yervoy was not yet reached (95% CI: 28.2 to not estimable [NE]), compared to 25.9 months for patients treated with sunitinib. Opdivo plus low-dose Yervoy also delivered durable responses with a higher objective response rate of 41.6% (95% CI: 36.9 to 46.5; p<0.0001; n=177/425) versus 26.5% for sunitinib (95% CI: 22.4 to 31.0; n=112/422). Median duration of response (durability) for Opdivo plus low-dose Yervoy was not yet reached (95% CI: 21.8 to NE) among responded patients, compared to 18.2 months for sunitinib (95% CI: 14.8 to NE). The overall safety profile was consistent with prior studies of Opdivo in combination with low-dose Yervoy.

The results of the CheckMate -214 study were first presented at the European Society for Medical Oncology (ESMO) 2017 Congress and were published in the New England Journal of Medicine in March 2018.

About CheckMate -214

CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg versus sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC). In the intermediate- and poor-risk study population, 425 patients received Opdivo 3 mg/kg plus Yervoy 1 mg/kg every three weeks for four doses, followed by Opdivo 3 mg/kg every two weeks, and 422 patients received sunitinib 50 mg once daily for four weeks, followed by two weeks off every cycle. The recommended dosing for the Opdivo plus low-dose Yervoy combination is Opdivo 3 mg/kg followed by Yervoy 1 mg/kg each infused intravenously over 30 minutes on the same day every three weeks for four doses. After completing four doses of the combination, Opdivo should be administered intravenously 240 mg every two weeks over 30 minutes or 480 mg every four weeks over 60 minutes until disease progression or unacceptable toxicity.

The co-primary efficacy outcome measures of the trial were overall survival, objective response rate (Complete Response + Partial Response) and progression-free survival as determined by an independent radiographic review committee (IRRC) in intermediate- and poor-risk patients. Patients were included regardless of their PD-L1 status.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for more than 140,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all patients. 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%.

Bristol-Myers Squibb: Advancing Oncology Research

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance the I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.