Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Distant Metastasis or Death by 40% Versus Placebo as Adjuvant Treatment in Resected, High-Risk Stage III Melanoma

September 21, 2020 /Bio ValleyBIOON/ -- Merck & Co. and the European Organisation for Research and Treatment of Cancer (EORTC) recently announced at the 2020 European MedicalTumorThe latest results of the Phase 3 EORTC 1325/KEYNOTE-054 study were presented at the European Society for Medical Oncology (ESMO) Virtual Congress.

This study is evaluating the anti-PD-1 therapy Keytruda (KEYTRUDA®, generic name: pembrolizumab) as an adjuvant treatment for resected, high-risk stage IIIMelanomaPatient.

Data show that after 3.5 years of follow-up, adjuvant Keytruda therapy met the key secondary endpoint of distant metastasis-free survival (DMFS): compared with placebo, adjuvant Keytruda therapy significantly reduced the risk of distant metastasis or death by 40% (HR=0.60; 95% CI: 0.49-0.73, p<0.001). The 3.5-year DMFS rate was 65.3% in the Keytruda group and 49.4% in the placebo group.

Furthermore, Keytruda in stage IIIA (>1 mm lymph node metastasis), stage IIIB, and stage IIICMelanomaCompared with placebo, it demonstrated a durable recurrence-free survival (RFS), with 3.5-year RFS rates of 59.8% in the Keytruda group versus 41.4% in the placebo group (HR=0.59 [95% CI, 0.49–0.70]; p<0.001). Benefits in RFS and distant metastasis-free survival (DMFS) were observed across key subgroups, including disease stage (according to AJCC-7 and AJCC-8), BRAF mutation status, and PD-L1 expression.

Furthermore, in AJCC-7 stage IIIA (HR=0.64), IIIB (HR=0.58), and IIIC (HR=0.61)MelanomaAmong patients, Keytruda demonstrated similar benefits in terms of disease-free metastasis survival (DMFS). Adjuvant therapy with Keytruda reduced the incidence of first recurrence of distant metastases by 43% (at 3.5 years: 24.9% vs 39.5%, HR=0.57 [95% CI, 0.46-0.72]; p<0.001).

No new safety data were identified in the 42-month analysis. The safety profile of Keytruda was consistent with that previously reported in advancedMelanomaThe study results were consistent among patients. The incidence of grade 3–5 immune-related adverse events was 7.7% in patients treated with Keytruda and 0.6% in those receiving placebo.

Based on the results of the EORTC 1325/KEYNOTE-054 study, Keytruda has currently been approved in more than 70 countries as an adjuvant therapy for the treatment of completely resected, node-positiveMelanomaPatients. MSD’s extensive clinical development program in melanoma and skin cancer is addressing areas of unmet need through studies of Keytruda in earlier stages of disease and in combination with other anticancer therapies, across multiple potential registration-enabling studies, including KEYNOTE-716, LEAP-003, and LEAP-004.(Bioon.com)

Original Source: Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Distant Metastasis or Death by 40% Versus Placebo as Adjuvant Treatment in Resected, High-Risk Stage III Melanoma