October 02, 2020: “Bristol Myers Squibb announced results for the co-primary endpoint for CheckMate -915, a randomized Phase 3 study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma.
The addition of Yervoy to Opdivo in this trial did not result in a statistically significant improvement in recurrence-free survival (RFS) in the all-comer (intent-to-treat) population. CheckMate -915 reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting.
The safety profiles for Opdivo monotherapy and the combination of Opdivo plus Yervoy were consistent with previously reported studies at this dose and schedule (Opdivo 240 mg intravenously every two weeks plus Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for up to one year), with no new safety signals observed.
“We are proud of our legacy in melanoma with both Opdivo and Yervoy.
They have each brought significant benefit as monotherapies for appropriate melanoma patients in the adjuvant setting, and as a dual immunotherapy regimen in the metastatic setting.
In CheckMate -915, we evaluated adding Yervoy to Opdivo against Opdivo – an established, active comparator and current standard of care in the adjuvant setting.
We designed this study to determine if dual immunotherapy has the potential to bring additional benefits to patients in this setting, understanding the high benchmark we would need to exceed with this trial,” said Sabine Maier, M.D., vice president, Head of Oncology Clinical Development, Bristol Myers Squibb.
“We remain committed to continued research in melanoma, both to further understand the potential benefit of Yervoy in combination with Opdivo to treat high-risk melanoma patients in the earlier stages of disease, as well as to study additional novel combinations in various settings.”
Bristol Myers Squibb will complete a full evaluation of the CheckMate -915 data and work with investigators to share the results at an upcoming medical conference.
Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -915 clinical trial.
CheckMate -915 is a Phase 3, randomized, placebo-controlled, double-blind study evaluating Opdivo in combination with Yervoy versus Opdivo monotherapy, an approved standard of care, in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV (per AJCC 8th edition; no evidence of disease) melanoma.
Patients enrolled in the trial had no prior systemic anti-cancer treatment for melanoma, except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy after neurosurgical resection for central nervous system lesions.
The trial randomized 1,943 patients to receive either Opdivo 240 mg intravenously every two weeks and Yervoy 1 mg/kg every six weeks or Opdivo 480 mg every four weeks for up to one year.
In November 2019, Bristol Myers Squibb announced that a statistically significant benefit was not reached for the co-primary endpoint of recurrence-free survival (RFS) in patients whose tumors expressed PD-L1 <1%.