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Adjuvant pembrolizumab provides a continued benefit for patients with stage IIB or IIC melanoma at 3 years, according to research presented at the ASCO Annual Meeting 2023.
Updated data from the KEYNOTE-716 trial showed that adjuvant pembrolizumab improved distant-metastasis-free survival (DMFS) and recurrence-free survival (RFS) at 3 years, when compared to placebo.
These results support the use of pembrolizumab as standard care for patients with resected stage IIB or IIC melanoma, said study presenter Jason J. Luke, MD, of UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania.
The KEYNOTE-716 trial (ClinicalTrials.gov Identifier: NCT03553836) included 976 patients aged 12 years or older with resected stage IIB or IIC cutaneous melanoma and negative sentinel lymph node biopsy.
The patients were randomly assigned to receive adjuvant pembrolizumab (n=487) or placebo (n=489) every 3 weeks for up to 17 cycles. At recurrence, patients could cross over to receive pembrolizumab, or they could receive pembrolizumab again.
At a median follow-up of 39.4 months, the median DMFS was not reached in either treatment arm. The 36-month DMFS rate was 84.4% in the pembrolizumab arm and 74.7% in the placebo arm (hazard ratio [HR], 0.59; 95% CI, 0.44-0.79).
Among patients with stage IIB disease, the 36-month DMFS rate was 86.7% with pembrolizumab and 78.9% with placebo (HR, 0.62; 95% CI, 0.42-0.92). For patients with stage IIC disease, the 36-month DMFS rates were 80.9% and 68.1%, respectively (HR, 0.57; 95% CI, 0.36-0.88).
The median RFS was not reached in either treatment arm. The 36-month RFS rate was 76.2% with pembrolizumab and 63.4% with placebo (HR, 0.62; 95% CI, 0.49-0.79).
In patients with stage IIB disease, the 36-month RFS rate was 79.7% with pembrolizumab and 66.5% with placebo (HR, 0.58; 95% CI, 0.43-0.79). For patients with stage IIC disease, the 36-month RFS rates were 71.4% and 58.0%, respectively (HR, 0.65; 95% CI, 0.45-0.94).
Overall survival data are still immature. Dr Luke said safety data were similar to data reported in previous analyses.
“I really think it’s important that all patients are offered this treatment and that doctors don’t take it upon themselves to decide not to talk about it,” Dr Luke said in conclusion. “Patients can decide it might not be the best treatment for them, but it’s an FDA-approved therapy, and it should be offered to all patients.”
Disclosures: This research was supported Merck Sharp & Dohme LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Luke JJ, Ascierto PA, Khattak MA, et al. Pembrolizumab versus placebo as adjuvant therapy in stage IIB or IIC melanoma: Final analysis of distant metastasis-free survival in the phase 3 KEYNOTE-716 study. ASCO 2023. June 2-6, 2023. Abstract LBA9505.
This article originally appeared on Cancer Therapy Advisor
