Bristol-Myers Phase 3 Study Of Opdivo Vs Yervoy Meets Primary Goal
Wednesday, July 5, 2017
(RTTNews.com) - Bristol-Myers Squibb Co. ( BMY ) announced Wednesday that a Phase 3 study evaluating the safety and efficacy of adjuvant Opdivo in resected high-risk melanoma patients met primary endpoint. These data will be submitted for presentation at an upcoming medical conference.
CheckMate -238 is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy (ipilimumab) in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma.
The company noted that the study evaluating Opdivo3 mg/kg versus Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection demonstrated superior recurrence-free survival or RFS in patients receiving Opdivo compared to Yervoy.
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.
Vicki Goodman, development lead, Melanoma and Genitourinary Cancers, Bristol-Myers, said, "These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma. There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery."