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Merck's Keytruda (pembrolizumab) Receives EU Approval for Resected Stage III Melanoma in Adults

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Merck's Keytruda (pembrolizumab) Receives EU Approval for Resected Stage III Melanoma in Adults

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  • 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

Ref: Merck & Co | Image: Merck

 


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