Phase III EORTC1325/KEYNOTE-054 trial of Keytruda meets secondary endpoint in melanoma.- Merck Inc

Merck announced new and updated findings from the Phase III EORTC1325/KEYNOTE-054 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Late-breaking, first-time study results showed that with 3.5 years of follow-up, adjuvant Keytruda met the key secondary endpoint of distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 40% versus placebo (HR=0.60 [95% CI, 0.49-0.73]; p<0.001), with 3.5-year dmfs rates of 65.3% and 49.4%, respectively. in addition, keytruda demonstrated a sustained recurrence-free survival (rfs) benefit versus placebo across stage iiia (>1 mm lymph node metastasis), IIIB and IIIC melanoma, with 3.5-year RFS rates of 59.8% for Keytruda versus 41.4% for placebo (HR = 0.59 [95% CI, 0.49-0.70]; p<0.001). the rfs and dmfs benefits were observed across key subgroups, including disease stages (both according to ajcc-7 and ajcc-8), braf mutation status and pd-l1 expression. these late-breaking data were presented as a proffered paper at the european society for medical oncology (esmo) virtual congress 2020.comment: keytruda is currently approved for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection in more than 70 countries based on the results from eortc1325 keynote-054. merck’s broad clinical development program in melanoma and skin cancers is addressing areas of unmet need by investigating keytruda in earlier stages of disease and in combination with other anti-cancer therapies across multiple potential registration-enabling studies, including keynote-716, leap-003 and leap-004.>