CheckMate-915 Trial Does Not Meet Co-Primary End Point of RFS for Melanoma

Updated results from the randomized, phase 3 CheckMate-915 trial found that nivolumab (Opdivo) plus ipilimumab (Yervoy) did not result in a statistically significant improvement in recurrence-free survival (RFS) in the intention-to-treat population of participants, according to Bristol Myers Squibb, the developer of the agents.

The study is evaluating the nivolumab-ipilimumab combination versus nivolumab alone in patients who have had a complete surgical removal of stage IIIb/c/d or stave IV melanoma.

“We are proud of our legacy in melanoma with both [nivolumab] and [ipilimumab],” Sabine Maier, MD, vice president and head of Oncology Clinical Development at Bristol Myers Squibb, said in a press release. “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 [ipilimumab] to [nivolumab] against [nivolumab] – 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,” Maier continued. “We remain committed to continued research in melanoma, both to further understand the potential benefit of [ipilimumab] in combination with [nivolumab] to treat high-risk melanoma patients in the earlier stages of disease, as well as to study additional novel combinations in various settings.”

The randomized, placebo-controlled, double-blind, phase 3 study enrolled patients who had no prior systemic anti-cancer treatment for melanoma, except surgery for melanoma lesion(s) and/or adjuvant radiation therapy after neurosurgical resection for central nervous system lesions. Overall, 1943 patients were randomized to receive either 240 mg of nivolumab intravenously every 2 weeks and 1 mg/kg of ipilimumab every 6 weeks or 480 mg of nivolumab every 4 weeks for up to 1 year.

Notably, Bristol Myers Squibb previously announced in November 2019 that a statistically significant benefit was not reached for the co-primary end point of RFS in patients whose tumors expressed PD-L1 <1%.

CheckMate-915 reinforced the already established benefit of nivolumab monotherapy as a standard of care in the adjuvant setting. The safety profiles for nivolumab monotherapy and the combination of nivolumab plus ipilimumab were consistent with previously reported studies at the aforementioned dose and schedule, and no new safety signals observed.

Bristol Myers Squibb indicated that it will complete a full evaluation of the CheckMate-915 data moving forward and will also work with investigators to share the results at an upcoming medical conference.

Reference:

Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients [news release]. Princeton, New Jersey. Published October 2, 2020. Accessed October 5, 2020. https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Announces-Update-on-CheckMate--915-Evaluating-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Versus-Opdivo-in-Resected-High-Risk-Melanoma-Patients/default.aspx