Zai Lab To Present Updated Data From Phase 1b/2 Trial Of Zocilurtatug Pelitecan Showing Clinically Meaningful, Durable Anti-Tumor Responses In Patients With Previously Treated Advanced Extrapulmonary Neuroendocrine Carcinomas At The North American Neuroendocrine Tumor Society Symposium

In the Phase 1b/2 trial, zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, demonstrated clinically meaningful responses in patients with previously treated advanced extrapulmonary neuroendocrine carcinomas (epNECs), with a confirmed objective response rate (ORR) of 40.0% and a median duration of response (mDOR) of 5.6 months
Results indicate responses to zoci monotherapy treatment among multiple epNEC subtypes, including gastroenteropancreatic NEC (GEP-NEC) and other epNEC subgroups, with confirmed ORRs of 35.9% and 47.6%, respectively; deepening anti-tumor activity was observed over time
Zoci demonstrated a manageable safety profile, with a treatment-related discontinuation rate of less than 1%, no treatment-related deaths, and a low rate of interstitial lung disease (ILD)/pneumonitis (1.5%, 2 cases, both Grade 2)
Zai will pursue a potential accelerated approval pathway for zoci in previously treated advanced epNECs based on results from Phase 1/2 trial, with topline data of the full epNEC population expected in 2027
Global Phase 3 first-line maintenance trial of zoci monotherapy in epNECs expected to initiate in 2027