FDA Approves Adjuvant Pembrolizumab in Stage III Melanoma
Source: OncLive, March 2019
The FDA has approved the PD-1 inhibitor pembrolizumab (Keytruda) for the adjuvant treatment of patients with high-risk stage III melanoma with lymph node involvement following complete resection.1 This is the first anti–PD-1 therapy evaluated in the adjuvant setting across patients with stage IIIA, stage IIIB, and stage IIIC melanoma.
The approval is based on findings from the pivotal phase III EORTC 1325/KEYNOTE-054 trial, in which adjuvant pembrolizumab led to a 43% reduction in the risk of disease recurrence or death compared with placebo in this patient population (HR, 0.57; 95% CI, 0.46-0.70; P <.001).2,3
“As physicians, we are always looking to find ways to prevent cancer from returning in our patients,” said Alain Algazi, MD, associate clinical professor of medicine, Department of Medicine, Hematology/Oncology, University of California, San Francisco, Medical Center, in a press release. “Keytruda has demonstrated significant improvement in recurrence-free survival among stage III melanoma patients when compared to a placebo, and we now have a new option to help patients who have a high risk of recurrence.”