Three-year analysis of efficacy data from the phase III CheckMate -238 study evaluating adjuvant use of Opdivo versus Yervoy in patients with Stage III or Stage IV melanoma.- BMS

Bristol-Myers Squibb Company announced results of a three-year analysis of efficacy data from the Phase III 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. 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).>

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.