The P-II/III (TADPOLE) trial evaluates Tafinlar + Mekinist vs CT in patients aged 1 to 17yrs. with BRAF V600 pLGG who required 1st systemic treatment
The results showed ORR (47% vs 11%). In an additional analysis at a median follow-up of 18.9mos., m-PFS (20.1mos. vs 7.4mos.), tumors shrank or remained stable (86% vs 46%) and patients had a reduction in tumor size (89% vs 70%) after 1yr. of follow-up while QoL analysis favored Tafinlar + Mekinist at all time points
The safety profile was consistent with established safety observed in prior studies, patients had fewer grades ≥3 AEs (47% vs 94%), and discontinuations due to AEs (4% vs 18%). In a separate cohort, Tafinlar + Mekinist showed an independently assessed ORR (56.1%)
Ref: Globenewswire| Image: Novartis
