Merck’s Keytruda (pembrolizumab) Receives the Health Canada Approval as Adjuvant Treatment for Stage IIB or IIC Melanoma
Shots:
- The approval was based on the P-III (KEYNOTE-716) trial to evaluate 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 results showed an improvement in RFS at the first pre-specified interim analysis, patients treated with Keytruda had a recurrence or died (11% vs 17%) at the time of median follow-up of 14.3mos. The safety profile was consistent with prior reported studies, TRAEs led to discontinuation in 15% of patients
- Keytruda is a humanized mAb that prevents the interaction b/w PD-1 & its ligands, PD-L1 & PD-L2 causing T lymphocytes to become activated which may affect tumor & healthy cells
Ref: Newswire | Image: Merck
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