The P-III (KEYNOTE-716) trial evaluated Keytruda vs PBO in 976 adult and pediatric patients aged ≥12yrs. with resected stage IIB or IIC melanoma
The results showed a significant clinical improvement in DMFS at a median follow-up of 27.4mos., m- DMFS was not reached. Additionally at the median 27.4mos. follow-up, the therapy showed a reduction in the risk of recurrence, 81.2% vs 72.8% were recurrence-free @2yrs
The safety profile was consistent with prior reported studies & no new safety signals were observed at the time of DMFS analysis. TRAEs grade ≥3 (17% vs 5%), immune-mediated events and infusion reactions (38% vs 9%). The prespecified exploratory analysis showed that HRQoL was similar b/w Keytruda & PBO
Ref: Businesswire| Image: Merck
