First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations | NEJM

In a phase 3 international randomized trial, 324 patients with advanced nonsquamous NSCLC and EGFR exon 20 insertions received sunvozertinib (163) or carboplatin-pemetrexed (161) in a 1:1 allocation. Progression-free survival by blinded independent central review was longer with sunvozertinib at 10.3 versus 7.5 months (hazard ratio 0.65, 95% CI 0.50–0.85; P<0.001). At 12 months, progression-free survival was 46.1% with sunvozertinib versus 26.7% with chemotherapy, while overall survival data were immature with 38.9% maturity. Objective response rates were 58.9% versus 31.1%, with median best tumor size change of −42.1% versus −24.7% and median duration of response of 11.2 versus 7.1 months. Grade 3 or higher adverse events occurred in 75.5% versus 56.7% of patients, respectively, and crossover to sunvozertinib was permitted after confirmed progression.

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