Nanjing Leads Biolabs Co., Ltd. announced that China’s Center for Drug Evaluation has approved a randomized, double-blind, multi-centre Phase III study of Opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, in combination with platinum-based chemotherapy as first-line therapy for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC).
The forthcoming trial, led by Professor Shen Lin of Beijing Cancer Hospital and spanning multiple Chinese hospitals, builds on positive efficacy and safety signals from a completed Phase Ib/II proof-of-concept study whose detailed data will be presented at the 2026 ESMO Congress. Opamtistomig previously secured CDE clearance for a single-arm pivotal study in third-line and later EP-NEC; the new approval expands the candidate’s reach to first-line treatment settings.
Company strategy outlines: • Planned biologics licence application for Opamtistomig monotherapy in third-line and beyond EP-NEC during 3Q 2026. • At least two additional Phase III studies under preparation, covering up to 13 solid-tumour indications, including first-line non-small-cell lung cancer, biliary tract cancer, small-cell lung cancer and ovarian cancer. • Demonstrated first-in-class or best-in-class potential across four tumour types—EP-NEC, NSCLC, SCLC and BTC—in ongoing registrational or Phase II trials.
EP-NEC represents a high-unmet-need segment of neuroendocrine carcinoma, with current first-line platinum regimens delivering objective response rates of 30%–50% and median overall survival near one year. No standard regimens exist after progression, and second-line therapies achieve only 10%–25% response rates and median overall survival of roughly eight months.
Opamtistomig leverages Leads Biolabs’ proprietary X-body™ platform to provide conditional 4-1BB activation while blocking PD-L1, aiming to enhance T-cell responses against “cold” tumours. The molecule is the first 4-1BB agonist to reach pivotal single-arm registration globally and has received Breakthrough Therapy Designation from China’s NMPA (October 2024), U.S. FDA Fast Track Designation (January 2026) and EU Orphan Drug status for EP-NEC.
Leads Biolabs cautions that successful development and commercialisation of LBL-024 remain subject to further clinical and regulatory outcomes.
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