Nivolumab is a biomarker that has been shown to benefit the survival of patients with stage 2 melanoma patients compared with placebo.
Nivolumab (Opdivo; Bristo Myers Squibb) met the primary endpoint of the phase 3 CheckMate-76k trial as a single adjuvant treatment with a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) at the interim analysis for patients with completely resected state 2B/C melanoma.
“Stage IIB/C melanoma patients are at high risk of disease recurrence, with approximately one third of stage IIB and half of stage IIC patients experiencing recurrence within 5 years after surgery. The results of the CheckMate -76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in the treatment of melanoma,” said Gina Fusaro, PhD, development program lead, melanoma, Bristol Myers Squibb, in a press release.
The randomized phase 3, double-blind CheckMate-76k evaluated nivolumab as an adjuvant therapy for patients with completely resected stage 2B/C melanoma. The investigators studied the efficacy of the drug at 480 mg Q4W against the placebo for up to 1 year.
The secondary endpoints of the trial were overall survival (OS), distant metastatic-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety.
Melanoma results from uncontrolled melanocyte (pigment-producing cells) growth. Diagnoses have increased within the past 3 decades, and it is estimated that there will be 99,780 new cases and more than 7500 deaths in 2022.
The deadliest form of this cancer is metastatic melanoma, in which the cancer spreads from the skin to other organs. Although it can be easily treated at early stages, individual survival rates may decrease in advanced stages.
Bristol Myers Squibb conducted Checkmate -76k as part of a developmental program looking at nivolumab and treatment combinations including nivolumab for 7 different early-stage cancers.
Nivolumab is a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor that was designed to harness the body’s own immune system to create an anti-tumor response that fights cancer. It is a treatment option that has been used for various cancer types.
Nivolumab is the first ever PD-1 immune checkpoint inhibitor to get regulatory approval, as it is now approved in 65 countries as a combination treatment for metastatic melanoma.
“Recurrence represents a life-altering event for people living with cancer. Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence—a critical goal of improving patient outcomes,” Fusaro concluded in the press release.
The research team did not find any new safety signals at the interim analysis.
Bristol Myers Squibb. Bristol Myers Squibb Announces Adjuvant Treatment with Opdivo (nivolumab) Demonstrated Statistically Significant and Clinically Meaningful Improvement in Recurrence-Free Survival (RFS) in Patients with Stage IIB/C Melanoma in the CheckMate -76K Trial. Bms website. September 15, 2022. Accessed on September 16, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Announces-Adjuvant-Treatment-with-Opdivo-nivolumab-Demonstrated-Statistically-Significant-and-Clinically-Meaningful-Improvement-in-Recurrence-Free-Survival-RFS-in-Patients-with-Stage-IIBC-Melanoma-in-the-CheckMate--76K-Trial/default.aspx