2025-06-02 11:09ZL-1310 Overview - ZL-1310 is a DLL3-targeted antibody-drug conjugate (ADC) showing promising clinical activity in relapsed/refractory (r/r) ES-SCLC patients[21] - The ADC has a drug-to-antibody ratio (DAR) of 8[20, 21] Safety Profile - ZL-1310 demonstrated a well-tolerated safety profile in the study[28] - In patients receiving doses < 2.0 mg/kg, Grade ≥3 TRAEs occurred in 6% of patients, and serious TRAEs occurred in 4% of patients, with no TRAEs leading to drug discontinuation or death[28] - At doses ≥2.0mg/kg, any TEAE occurred in 95% of patients, with Grade ≥3 in 44% of patients[27] Efficacy in SCLC - In the dose escalation cohort (N=28), the confirmed ORR was 68%[33] - In 2L SCLC (N=33), the ORR was 67% and the Disease Control Rate (DCR) was 97%[37] - For patients with 1 prior line of therapy (N=33), the ORR was 67% and the DCR was 97%[38] - In patients with brain metastases at baseline (N=22), the ORR was 68%, and in those without prior radiation (N=7), the ORR was 86%[55] Study Design and Future Plans - A Phase 3 pivotal trial assessing ZL-1310 in ES-SCLC patients who have progressed during or after platinum-based therapy is planned to start later this year[56] - A randomized, registrational trial is initiating in 2H'25 with primary endpoints of OS and ORR[62]