LEADS BIOLABS-B (09887) announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the initiation of a confirmatory Phase 3 clinical study. This study will evaluate VELIXIN™ (the PD-L1/4-1BB bispecific antibody Opatumilab, LBL-024) in combination with platinum-based chemotherapy as a first-line treatment for patients with advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). This approval marks the successful advancement of Opatumilab's clinical development in EP-NEC from later-line monotherapy to first-line combination therapy. Previously, Opatumilab had received CDE approval for a single-arm pivotal registration study for third-line and above EP-NEC patients. The approval of this first-line Phase 3 study now expands Opatumilab's applicable patient population in the EP-NEC field, fundamentally reshaping the treatment landscape for this cancer type.
The upcoming randomized, double-blind, multicenter Phase 3 study will be led by Professor Shen Lin from Beijing Cancer Hospital and is being rolled out simultaneously across multiple hospitals nationwide. The approval of this study is based on the breakthrough efficacy and favorable safety profile demonstrated by Opatumilab in its Phase 1b/II proof-of-concept study. This proof-of-concept trial has been successfully completed, with detailed results planned for presentation at this year's ESMO congress.
As a key component of Opatumilab's overall development strategy for EP-NEC, the single-arm pivotal registration clinical study of Opatumilab monotherapy for third-line and above advanced EP-NEC patients is on track to submit its Biologics License Application (BLA) in the third quarter of 2026. Concurrently, the company is advancing multiple proof-of-concept studies for Opatumilab and planning at least two additional Phase 3 clinical trials. These efforts aim to explore its application across 13 solid tumor indications, including first-line non-small cell lung cancer, first-line biliary tract cancer, small cell lung cancer, and ovarian cancer, forming a comprehensive R&D layout covering multiple tumor types and stages. Opatumilab has already demonstrated first-in-class (FIC) or best-in-class (BIC) potential in registration or Phase II clinical trials for four indications: extrapulmonary neuroendocrine carcinoma, non-small cell lung cancer, small cell lung cancer, and biliary tract cancer.
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