Merck’s Keytruda (pembrolizumab) Receives EU Approval for Resected Stage III Melanoma in Adults
Merck’s Keytruda (pembrolizumab) Receives EU Approval for Resected Stage III Melanoma in Adults
- The approval is based on P-III EORTC1325/KEYNOTE-054 trial assessing Keytruda (IV 200mg, q3w) as adjuvant therapy vs PBO, in 1,019 patients in ratio (1:1) with completely resected melanoma (stage IIIA [>1 mm lymph node metastasis], IIIB or IIIC
- P-III EORTC1325/KEYNOTE-054 results: RFS@ 7mos. 44%, RFS@12, 18 mos. (76%, 72% vs 61%, 54%); BRAF positive tumors patients RFS @6 mos. (83% vs 73%)
- Keytruda (pembrolizumab) 100 mg is a mAb serving as an anti-PD-1 therapy for the tumor cells blocking the interaction b/w PD-1 and its ligands (PD-L1 and PD-L2), and is evaluated in 850 trials in oncology
Click here to read full press release/ article | Ref: Merck & Co| Image: Fox Business