Adjuvant therapy with nivolumab versus placebo in patients with resected stage IIB/C melanoma (CheckMate 76K)
Main Article Content
Keywords
adjuvant nivolumab, resected melanoma, stage IIB/C
Abstract
Patients with resected stage IIB/C melanoma are at high risk of recurrence with outcomes similar to patients with resected stage IIIB disease. Adjuvant NIVO has shown benefit in patients with resected stage III-IV melanoma. The phase 3 CheckMate 76K (NCT04099251) trial compared adjuvant NIVO vs PBO in patients with completely resected stage IIB/C melanoma. Patients aged ≥12 years were stratified by T category and randomized 2:1 to receive NIVO 480 mg or PBO, intravenously Q4W for 12 months. The primary endpoint was recurrence-free survival (RFS); safety was a key secondary endpoint. Overall, 790 patients were randomized to NIVO (526) vs PBO (264); 61% had stage IIB and 39% had stage IIC disease. Minimum follow-up was 8 months (median: 15.8 months NIVO; 15.9 months PBO); 66/526 (13%) vs 69/264 (26%) had a recurrence event. At this interim analysis, CheckMate 76K met the primary endpoint: NIVO significantly reduced the risk of recurrence vs PBO (stratified HR, 0.42; 95% CI, 0.30-0.59; stratified P<0.0001); 12-month RFS rates for NIVO vs PBO were 89% (95% CI, 86-92) vs 79% (74-84); substage rates were 93% vs 84% (IIB) and 84% vs 72% (IIC). RFS benefit was observed across predefined subgroups. For NIVO, 5% of all patients had distant recurrences and 2% regional; for PBO, it was 12% and 8%. Grade 3-4 treatment-related adverse events (TRAEs) for NIVO vs PBO were 10% vs 2%; any-grade TRAEs leading to discontinuation were 15% vs 3%. There was one treatment-related death (0.2%) with NIVO (heart failure and acute kidney injury). Adjuvant NIVO significantly improved RFS vs PBO and decreased the risk of recurrence or death by 58% in patients with resected stage IIB/C melanoma, with efficacy benefit across subgroups. The safety results were similar to the known anti–PD-1 monotherapy profile with no new safety signals. NIVO is an effective adjuvant treatment option with a clinically meaningful benefit in resected stage IIB/C melanoma. Encore presentation from Society of Melanoma Research, September 2022.
References
2. Garbe C, et al. J Clin Oncol 2020;38:2543–2551.
3. Gershenwald JE, et al. CA Cancer J Clin 2017;67:472–492.
4. Eggermont AMM, et al. Lancet Oncol 2015;16:522–530.
5. Weber J, et al. N Engl J Med 2017;377:1824–1835.
6. Weber J, et al. Presented at the Society for Melanoma Research (SMR) International Congress; October 28–31, 2021; virtual.
7. Eggermont, AMM, et al. N Engl J Med 2018;378:1789–1801.
8. Eggermont AMM, et al. Lancet Oncol 2021;22:643–554.
9. Luke JJ, et al. Lancet 2022;399:1718–1729.
Article Sidebar
Article Details
This work is licensed under a Creative Commons Attribution 4.0 International License.
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.