On June 1, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported patient-reported outcomes data from the Phase 3 CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) treated with the Immuno-Oncology combination Opdivo (nivolumab) plus low-dose (1mg/kg) Yervoy (ipilimumab) versus sunitinib over a two-year follow-up period (Press release, Bristol-Myers Squibb, JUN 1, 2018, View Source [SID1234527024]). Patients in the study treated with Opdivo plus low-dose Yervoy reported significant benefits in disease-related symptoms and improvements to their cancer-related quality of life and well-being. These benefits occurred early during Opdivo plus low-dose (1mg/kg) Yervoy combination therapy and were largely maintained throughout the treatment period and through Opdivo maintenance therapy.

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Relative to the current standard of care, patients in the Opdivo plus low-dose Yervoy arm reported fewer kidney cancer symptoms as measured by the NCCN Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19). This benefit was significant at all but one post-baseline time point through two years of follow-up (P<0.05). Time to deterioration (TTD) in FKSI-19 total score was also significantly delayed with Opdivo plus low-dose Yervoy versus sunitinib (HR 0.54; 95% CI, 0.46–0.63; P < 0.0001).

An additional analysis showed similar results with a significant benefit seen for Opdivo plus low-dose Yervoy relative to sunitinib on change from baseline at a pre-planned 25-week landmark. Assessed by FKSI-19 total score, with a mean difference of 3.55 (1.65 vs -1.9; P<0.0001), the analysis showed that patients in the Opdivo plus low-dose Yervoy arm experienced significantly better health-related quality of life scores in regard to disease-related symptoms, treatment side effects and functioning.

Additionally, longitudinal changes from baseline in health-related quality of life between treatment arms at 25 weeks, as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G), also demonstrated a significant advantage for Opdivo plus low-dose Yervoy, with a mean difference of 3.71 (1.52 vs -2.19; P<0.0009) in the total score between arms. Confirmatory results from FACT-G also showed significantly higher scores in the combination arm across a number of measures, including physical, functional and emotional well-being. Collectively, these data suggest a significant and consistent patient reported benefit of the combination relative to standard of care.

"With CheckMate -214, for patients with advanced renal cell carcinoma, we have previously seen the efficacy benefit of Opdivo plus low-dose Yervoy across a number of measures, including overall survival, objective response rate and progression-free survival," said David Cella, Ph.D., chair, Department of Medical Social Sciences, and director, Institute for Public Health and Medicine – Center for Patient-Centered Outcomes, Northwestern University Feinberg School of Medicine, Chicago. "What we now add with this analysis is evidence that patients treated with this Immuno-Oncology combination also reported significant improvements in disease-related symptoms, as well as positive changes to their physical, emotional and functional well-being."

John O’Donnell, MPP, Ph.D., vice president, worldwide health economics and outcomes research, Bristol-Myers Squibb, said, "The analysis of patient-reported outcomes in CheckMate -214 is particularly relevant for patients with advanced renal cell carcinoma as it shows that the combination of Opdivo plus low-dose Yervoy not only provides therapeutic benefits over a current standard of care but it demonstrates improvements in patient health-related quality of life that were sustained over the two-year follow-up period. These results attest to our leadership in Immuno-Oncology and our commitment to providing physicians with treatment options that make a difference in patients’ lives."

Findings will be presented during the Developmental Therapeutics—Immunotherapy poster session on Monday, June 4 from 8:00-11:30 AM CDT at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2018 in Chicago (Abstract #3073).

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 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 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 or 480 mg every four weeks over 30 minutes until disease progression or unacceptable toxicity.

The primary efficacy outcome measures of the trial were OS, ORR (CR+PR) and PFS as determined by an independent radiographic review committee (IRRC) in intermediate- and poor-risk patients. Patients were included regardless of their PD-L1 status. Data from CheckMate -214 were previously presented at the European Society for Medical Oncology Congress in September 2017 and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2017 and were published in the New England Journal of Medicine in March 2018.

About Renal Cell Carcinoma

Renal cell carcinoma is the most common type of kidney cancer in adults, accounting for nearly 15,000 deaths in the United States each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 70% to 80% of all patients. Renal cell carcinoma is approximately twice as common in men as in women. In the United States, the five-year survival rate for those diagnosed with metastatic, or advanced, kidney cancer is 8%.