(Melanoma) Is Opdivo + Yervoy Effective for Brain Metastases? — CheckMate 204 3-Year Follow-Up
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On November 11, 2021, Hussein A. Tawbi and colleagues from the University of Texas MD Anderson Cancer Center published 3-year follow-up efficacy and safety results of the CheckMate 204 Phase II clinical trial in The Lancet Oncology, evaluating nivolumab (Opdivo, anti-PD-1) plus ipilimumab (Yervoy, anti-CTLA-4) in patients with malignant melanoma with brain metastases.
The CheckMate 204 Phase II trial was a multicenter, open-label study. Patients with malignant melanoma with brain metastases (N=119) received nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) every 3 weeks for 4 cycles, followed by nivolumab monotherapy (3 mg/kg) every 2 weeks for up to 2 years, or until disease progression or unacceptable toxicity. The primary endpoint was intracranial clinical benefit rate; secondary endpoints were intracranial progression-free survival and overall survival. Patients were stratified into cohort A (asymptomatic, N=101) and cohort B (symptomatic, N=18).
Results:
Intracranial clinical benefit rate (primary endpoint): cohort A 57.4% (N=58) / cohort B 16.7% (N=3). Complete response: cohort A 33% (N=33) / cohort B 17% (N=3).
Cohort A secondary endpoints at 36 months: intracranial PFS rate 54.1%; OS rate 36.6%.
Safety:
Most common Grade 3–4 adverse events: cohort A — AST/ALT elevation 15% (N=15); cohort B — none. Serious adverse events in cohort A included colitis, diarrhea, hypophysitis, and ALT elevation; cohort B had none.
Based on the 3-year follow-up results of the CheckMate 204 trial, Hussein A. Tawbi and colleagues concluded that nivolumab plus ipilimumab demonstrated durable antitumor activity, improving intracranial progression-free survival and overall survival in patients with malignant melanoma with brain metastases.
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00545-3/fulltext
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