Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma

Source: Onc live, May 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. Additionally, CHMP recommended expanding the indication for pembrolizumab in advanced unresectable or metastatic and stage III melanoma as adjuvant therapy following complete resection for adolescent patients aged 12 years and older.

The positive opinion was based on findings from the phase 3 KEYNOTE-716 trial (NCT03553836), in which pembrolizumab demonstrated a statistically significant improvement in recurrence-free survival (RFS) vs placebo in patients 12 years and older with stage IIB and IIC melanoma following complete resection (HR, 0.65; 95% CI, 0.46-0.92; P = .00658).

Additionally, pembrolizumab demonstrated significant improvements in RFS (HR, 0.57; 95% CI, 0.46-0.70; P < .001) and distant metastasis-free survival (DMFS; HR, 0.60; 95% CI, 0.49-0.73; P < .001) vs placebo in patients with stage III melanoma in the phase 3 KEYNOTE-054 trial (NCT02362594).