Adjuvant Pembrolizumab Results in Significant DMFS Improvement Over Placebo in Stage II Melanoma

Source: Onc Live, June 2022

Adjuvant pembrolizumab (Keytruda) was found to result in a significant improvement in distant metastasis-free survival (DMFS) compared with placebo, with a continued reduction in risk of recurrence and an acceptable safety profile in patients with resected stage IIB or stage IIC melanoma, according to data from the third interim analysis of the KEYNOTE-716 trial (NCT03553836) presented during the 2022 ASCO Annual Meeting.

After a median follow up of 27.4 months (range, 14.0-39.4), patients in the pembrolizumab arm experienced a better 24-month DMFS rate of 88.1% compared with 82.2% for those who received placebo. The 12-month DMFS also favored pembrolizumab with 94.7% vs 90.2% in the placebo arm.

The median DMFS was not yet reached in either the pembrolizumab or placebo arms. The number of events were fewer in the pembrolizumab arm than the placebo, affecting 63 patients (12.9%) vs 95 patients (19.4%), respectively (hazard ratio [HR] 0.64, 95% CI, 0.47-0.88; P = .0029).