On August 22, 2023 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection, based upon results from the CheckMate -76K trial (Press release, Bristol-Myers Squibb, AUG 22, 2023, View Source [SID1234634614]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
This approval builds upon the 2018 EC approval based on results from the CheckMate -238 trial. Opdivo is now indicated for use in the European Union as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Opdivo is now the only PD-1 inhibitor that – between two approvals – is indicated as an adjuvant treatment within stages IIB, IIC, III, as well as stageIV resected melanoma.
"Patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery. This can be a very impactful event for patients," said Peter Mohr, MD, Chief Physician and Head, Skin Cancer Center, Buxtehude, Department of Dermatology, Elbe-Kliniken, Germany. "This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring."
The EC’s decision is based on results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI: 0.30-0.59; p<0.0001). The safety profile of Opdivo was consistent with previously reported studies.
CheckMate -76K is part of Bristol Myers Squibb’s development program which explores the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.
"With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence," said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. "This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer. We thank all the patients, researchers, and physicians who were involved along the way to help make this additional option for patients possible."
The EC approval covers all European Union member states, as well as Iceland, Liechtenstein, and Norway. Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland, Wales).
CheckMate –76K Efficacy and Safety Results
Results from the CheckMate –76K study evaluating adjuvant Opdivo versus placebo in patients with completely resected stage IIB or IIC melanoma include:
Efficacy: Adjuvant Opdivo, with a minimum follow-up of 7.8 months, reduced the risk of recurrence or death by 58% versus placebo (HR 0.42; 95% CI: 0.30-0.59; p<0.0001). Twelve-month recurrence-free survival (RFS) rates for Opdivo were 89% (95% CI: 86-92) versus 79% (CI: 74-84) for placebo. The RFS benefit was observed across predefined subgroups in the trial, including T category and disease stage.
Safety: In the pooled dataset of nivolumab as monotherapy across tumor types (n = 4646) with minimum follow-up ranging from 2.3 to 28 months, the most frequent adverse reactions (≥ 10%) were fatigue (44%), musculoskeletal pain (28%), diarrhea (26%), rash (24%), cough (22%), nausea (22%), pruritus (19%), decreased appetite (17%), arthralgia (17%), constipation (16%), dyspnoea (16%), abdominal pain (15%), upper respiratory tract infection (15%), pyrexia (13%), headache (13%), anemia (13%) and vomiting (12%). The majority of adverse reactions were mild to moderate (Grade 1 or 2).
About CheckMate -76K
CheckMate -76K is a randomized Phase 3, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg Q4W for up to 12 months versus placebo in patients with completely resected stage IIB or IIC melanoma.
The primary endpoint of the trial is recurrence-free survival (RFS). Secondary endpoints of the trial include overall survival (OS), distant metastases-free survival (DMFS), progression-free survival on next-line therapy (PFS2), and safety endpoints.
About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths. Melanomas can be mostly treatable when caught in very early stages; however, survival rates can decrease as the disease progresses.