Merck Reports Results of Keytruda (pembrolizumab) in P-III (KEYNOTE-716) Trial for the Treatment of Resected Stage IIB and IIC Melanoma
Shots:
- The P-III (KEYNOTE-716) trial evaluates Keytruda (200mg or the pediatric dose 2mg/kg, IV, q3w, for ~1yr.) vs PBO in 976 patients aged ≥12 yrs. with resected stage IIB or IIC melanoma
- The trial met its 2EPs i.e., the therapy showed an improvement of DMFS at a pre-specified interim analysis & also showed an improvement in RFS over PBO, improvement in the time until the first diagnosis of distant metastasis with no new safety signals. In previous studies, the trial met the 1EPs of RFS at the first interim analysis
- Keytruda has received the US FDA’s approval for the adjuvant treatment of adult and pediatric patients aged ≥12 yrs. with the same indication
Ref: Merck | Image: Merck
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