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5% (4/74, 95% CI: 1.513.3) with placebo (p=0.011) 86% of responders in the selumetinib arm had a duration of response of at least 6 months Chronic pain score improvement was observed in the selumetinib arm, though the difference did not reach statistical significance (p=0.070) in patients with baseline pain scores 3 The safety profile was consistent with selumetinibs established profile from pediatric use, including manageable toxicities such as gastrointestinal effects, skin toxicity, and elevated creatine phosphokinase An ORR of 20% in a placebo-controlled PN trial, against a 5% placebo response rate, with durable responses in the majority of responders, constitutes the most robust efficacy evidence ever generated in adult NF1-PN, a population in which the prior standard of care was surgical debulking, pain management, and watchful waiting

Liang, J

DjokoKYPhanMDPetersKMWalkerMJSchembriMAMcEwanAGet al

63 , ciw506 (2016)