China’s NMPA accepted the NDA for opamtistomig (LBL-024) as monotherapy for previously treated advanced extrapulmonary neuroendocrine carcinoma. The agency’s Center for Drug Evaluation granted priority review, with the filing supported by a registrational study led by Lin Shen, MD, of Peking University Cancer Hospital. The program targets PD-L1 and 4-1BB via a bispecific antibody designed to conditionally activate 4-1BB signaling while blocking PD-1/PD-L1 immune suppression. Opamtistomig has previously received breakthrough therapy designation, and earlier reported results cited an ORR of 33.3% in EP-NEC. If approved, it would represent the first marketed therapy directly targeting 4-1BB, adding another immuno-oncology mechanism for a disease area described as lacking approved options globally.
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