23P SHR-A2009, a HER3-targeted ADC, plus bevacizumab (Bev) for pretreated EGFR-mutated non-squamous (EGFRm nsq) NSCLC: A phase Ib/II study

with EGFR-mutated advanced NSCLC who progressed on or after standard EGFR TKI treatment.Methods: Pts received pumitamig + carboplatin + pemetrexed for 4 cycles, then pumitamig + pemetrexed maintenance.ORR and PFS were primary endpoints; OS and safety were secondary.Analysis by PD-L1 expression was determined by immunohistochemistry and classified based on tumor proportion score as negative (< 1%), low (1%-49%), or high ( 50%).Results: As of Oct 18, 2025, 64 pts were enrolled.Median age was 59 years and 89.1% had ECOG PS 1.All pts were evaluable for safety, efficacy, and PD-L1 expression.With a median follow-up of 20.4 mo, median PFS was 9.6 mo with a 42.4% 12-mo PFS rate and median OS was NR with a 79.7% 12-mo OS rate.Activity was observed across all PD-L1 levels (Table ).Treatment-related adverse events (TRAE, related to any drug) were reported in all pts, and were Grade 3 in 68.8% (44/64).Main TRAEs included hematological AEs, elevated transaminases and proteinuria.TRAEs led to treatment discontinuation in 12 pts and to death in 1 pt due to pneumonia.Any-grade immune-related AEs (irAEs) occurred in 31.3%(20/64) and grade 3 irAEs in 7.8% (5/64) of pts.Conclusions: Pumitamig + chemo showed encouraging PFS and OS across PD-L1 levels including PD-L1 < 1% with a safety profile consistent with previous reports in pts with EGFR-mutated NSCLC who progressed on or after EGFR-TKI therapy.Greatest benefit was seen in pts with high PD-L1 expression.