New EC approval for Merck's Keytruda

Merck & Co (NYSE: MRK) today announced that the European Commission (EC) has approved Keytruda (pembrolizumab) Merck’s mega-blockbuster anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.

Additionally, the EC approved expanding the indications for Keytruda in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients aged 12 years and older.

The approval of Keytruda for the adjuvant treatment of patients with resected stage IIB or IIC melanoma was based on results from the Phase III KEYNOTE-716 trial, in which Keytruda significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 39% (HR=0.61 [95% CI, 0.45-0.82]; p=0.00046) compared to placebo in this patient population at a median follow-up of 20.5 months. Keytruda in this adjuvant setting also significantly prolonged distant metastasis-free survival (DMFS), reducing the risk of distant metastasis by 36% (HR=0.64 [95% CI, 0.47-0.88]; p=0.00292) compared to placebo in this patient population at a median follow-up of 26.9 months.