EU approves Opdivo monotherapy as adjuvant treatment for stage IIB or IIC melanoma
Bristol Myers Squibb announced 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
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 stage IV resected melanoma.
The EC’s decision is based on results from the Phase III 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.
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 (at least 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).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.