Studeni 2023: Nivolumab (Opdivo, Bristol-Myers Squibb Company) was granted approval by the Food and Drug Administration as an adjuvant therapy for Stage IIB/C melanoma in patients 12 years of age and older who had undergone complete resection.
In the randomized, double-blind trial CHECKMATE-76K (NCT04099251), which included 790 patients with Stage IIB/C melanoma, efficacy was assessed. A placebo or 480 mg nivolumab was administered intravenously to patients in a randomized (2:1) fashion every four weeks for a maximum of one year, or until disease recurrence or unacceptable toxicity occurred.
A complete resection of the primary melanoma with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization, as well as an ECOG performance status of 0 or 1, were prerequisites for enrollment. Patients who met the inclusion criteria for the trial did not have ocular/uveal or mucosal melanoma, autoimmune disease, any condition necessitating systemic treatment with corticosteroids (equivalent to or exceeding 10 mg of daily prednisone) or other immunosuppressive drugs, or prior melanoma therapy other than surgery. AJCC 8th staging system edition stratification of randomization was employed (T3b versus T4a versus T4b).
Primarna mjera ishoda učinkovitosti bilo je preživljenje bez recidiva (RFS), koje su istraživači definirali kao vrijeme između randomizacije i najranijeg od sljedećih događaja—povratak lokalnih, regionalnih ili udaljenih metastaza, novi primarni melanom ili smrtnost (iz bilo kojeg uzroka) ). Procjene su obavljene u intervalima od 26 tjedana od prve do treće godine, a zatim svaka 52 tjedna sljedećih pet godina. I u skupini s nivolumabom i u skupini koja je primala placebo, srednji RFS nije postignut (95% CI: 28.5, nije postignut; p-vrijednost<0.0001). Omjer rizika bio je 0.42 [95% CI: 0.30, 0.59]; p-vrijednost bila je manja od 0.0001.
Mood swings, musculoskeletal pain, pruritis, rash, and diarrhea were the most frequently reported adverse effects (>20% of patients).
Patients weighing 40 kg or more are advised to take 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity, for a maximum of one year. For up to one year, pediatric patients weighing less than 40 kg are prescribed a dosage of 3 mg/kg every two weeks or 6 mg/kg every four weeks, until disease progression or unacceptable toxicity occurs.
