Adjuvant Pembrolizumab Improved Distant Metastasis-Free Survival In Resected Stage IIB, IIC Melanoma

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Adjuvant pembrolizumab (pembro) significantly improved distant metastasis-free survival (DMFS), with continued reduction in the risk of recurrence, compared with placebo in patients with resected stage IIB and IIC melanoma, according to research presented at the 2022 ASCO Annual Meeting.

Georgina Long, MD, PhD, presented new KEYNOTE-716 data from the analysis of DMFS and recurrence-free survival (RFS) with longer follow up (ClinicalTrials.gov Identifier: NCT03553836). 

Patients (aged 12 years and older) with complete resection of cutaneous stage IIB or IIC melanoma and negative sentinel lymph node biopsy were randomly assigned (1:1) to receive pembro (2 mg/kg for pediatric patients and 200 mg IV for adult patients) or placebo every 3 weeks for 17 cycles (approximately 1 year). The primary endpoint was RFS per investigator. Secondary endpoints included DMFS by investigator. The data cut-off date for the interim analysis was January 4, 2022.


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A total of 976 patients were included in the study, with 487 (62% male) and 489 patients (59% male) in the pembro and placebo arms, respectively. Baseline characteristics were well balanced across the arms. The median age was 60 years (range, 16 to 84) and 61 years (range, 17 to 87) in the pembro and placebo arms, respectively.

At median follow-up of 27.4 months (range, 14.0 to 39.4), adjuvant pembro significantly improved DMFS compared with placebo (hazard ratio [HR], 0.64; 95% CI, 0.47-0.88; P =.0029; median not reached [NR] for both). The 24-month DMFS rate was 88.1% with adjuvant pembro and 82.2% with placebo. With further follow up (median, 37.2 months), the risk of recurrence was consistently reduced with pembro relative to placebo (HR 0.64; 95% CI, 0.50-0.84), demonstrating a 24-month RFS rate of 81.2% with pembro and 72.8% with placebo.

Dr Long reported a favorable benefit-risk profile for adjuvant pembro. Grade 3 or higher any-cause adverse events (AEs) occurred in 28% of the pembro arm and 20% of the placebo arm, and grade 3 or higher drug-related AEs occurred in 17% vs 5% of patients, respectively. No drug-related deaths occurred. Immune-mediated AEs occurred in 38% of the pembro arm and 9% of the placebo arm; the most common was hypothyroidism (16% vs 3%).

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

Reference

Long GV, Luke JJ, Khattak M, et al. Distant metastasis-free survival with pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: the phase 3 KEYNOTE-716 study. Presented at ASCO 2022; June 3-7, 2022. Abstract LBA9500.



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