Bristol-Myers Squibb Company today announced 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. 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.
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."