Opdivo superior recurrence-free survival (RFS) compared to Yervoy in resected high-risk melanoma patients

Bristol Myers Squib’s adjuvant treatment with Opdivo (nivolumab) further showed extended recurrence-free survival at three years in resected high-risk melanoma patients, being the longest follow-up of any PD-1 inhibitor in the adjuvant melanoma setting.

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BMS—Bristol-Myers Squibb Company (NYSE: BMY) today announced results of a three-year analysis of efficacy data from the Phase 3 CheckMate -238 study evaluating adjuvant use of Opdivo (nivolumab) 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients with Stage III or Stage IV melanoma who were at high risk of recurrence following complete surgical resection. At three years of follow-up, Opdivo continues to demonstrate superior recurrence-free survival (RFS) compared to Yervoy, the active control, with RFS rates of 58% and 45%, respectively (HR 0.68; p<0.0001). Distant-metastasis-free survival (DMFS) also continues to be significantly longer for Opdivo, with 36-month rates of 66% and 58%, respectively (hazard ratio 0.78, p=0.044). Both RFS and DMFS benefit continue to be observed across key subgroups, including disease stages, BRAF mutation status and PD-L1 expression. No new safety data were generated as part of the 36-month analysis.

“For patients with surgically resected, advanced melanoma at high risk of recurrence, these three-year data are highly significant as they provide additional support showing the long-term benefits of adjuvant nivolumab treatment in decreasing disease recurrence,” said Jeffrey S. Weber, M.D., Ph.D., CheckMate -238 investigator and deputy director of the Perlmutter Cancer Center at New York University Langone Medical Center. “The continued separation of the curves points to the long-term potential of nivolumab to provide a durable benefit for this patient population.”

Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb, said, “In this study of resected Stage III and Stage IV high-risk melanoma patients, Opdivo continues to demonstrate sustained long-term improvements in the prevention of disease recurrence over Yervoy, the active control.”

Data from this analysis will be featured at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain (Saturday, September 28 from 8:30-10:15 AM CEST).

About CheckMate -238

CheckMate -238 is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma. The trial randomized 906 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or Yervoy 10 mg/kg IV every three weeks for four doses and then every 12 weeks until documented disease progression or unacceptable toxicity, up to a maximum treatment duration of one year. The primary endpoint is recurrence-free survival, defined as the time between randomization and the date of first recurrence or death. The secondary endpoint is overall survival.

Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (stages 0-4) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.

Stage 3 melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized) and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy. Despite surgical intervention, most patients experience disease recurrence and progress to metastatic disease.