Overview

• In the 2.5 mg/kg D1D8 Q3W cohort (n=40), the regimen achieved a 100% ORR with a 95.0% confirmed ORR, a 12-month PFS rate of 92.1%, and median DOR and PFS not yet reached at a 12.8-month follow-up.
• Across all 154 patients treated in the combination study, the ORR was 84.4% with a confirmed ORR of 80.5%, the 12-month PFS rate was 86.5%, and the 12-month OS rate was 95.9%.
• Hematologic toxicities were frequent (anemia 91.9%, neutropenia 91.1%, leukopenia 91.1%, thrombocytopenia 75.6%), higher-grade events were managed with dose modification and supportive care, treatment discontinuation due to TRAEs was 13.0%, and two cases of interstitial lung disease were reported.
• In a separate 2.5 mg/kg monotherapy subgroup of 50 previously TKI-treated, chemo-naive patients, the ORR was 66.0% with a 56.0% confirmed ORR, mPFS reached 12.5 months, mDOR reached 13.7 months, discontinuation for TRAEs was 1.2%, and no treatment-related deaths occurred.
• Further evaluation is underway in China with a registrational phase 3 monotherapy trial after third-generation TKI progression and a randomized first-line phase 3 trial testing the combination at 2.5 mg/kg.