FDA Approves Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma Following CR

 Source: OncLive, December 2021

The FDA has approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection (CR).

The regulatory agency also expanded the indication for the immunotherapy for adjuvant use in patients with stage III melanoma following CR to include pediatric patients aged 12 yers and older.

The indication for the agent’s use in patients with stage IIB and IIC melanoma is based on findings from the first interim analysis of the phase 3 KEYNOTE-716 trial (NCT03553836), in which pembrolizumab resulted in a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% (HR = 0.65; 95% CI, 0.46-0.92; P = .0132) vs placebo. Specifically, the median RFS was not reached in either treatment arm.