LEADS BIOLABS-B (09887) has announced that its independently developed PD-L1/4-1BB bispecific antibody, Opatsosumimab (Vilitis™), has successfully completed the safety run-in assessment in a Phase II clinical study for first-line treatment of hepatocellular carcinoma (HCC). This milestone, confirmed by expert review, allows the study to proceed into the expansion phase. The research is led by Professor Zhou Jian, President of Zhongshan Hospital affiliated with Fudan University and an academician of the Chinese Academy of Sciences.
Preliminary data from the study indicate that Opatsosumimab combined with bevacizumab demonstrates clear and positive efficacy signals in HCC patients, with a favorable overall safety and tolerability profile. HCC ranks as the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China, with approximately 368,000 new cases and 317,000 deaths annually. The disease often presents asymptomatically, and fewer than 30% of patients are eligible for curative treatment at initial diagnosis, underscoring the critical role of systemic anti-tumor therapy in managing intermediate to advanced stages.
Currently, PD-1/PD-L1 inhibitors combined with bevacizumab are a standard first-line treatment for advanced HCC globally. However, patients achieve a median overall survival of only 19 to 20 months, a median progression-free survival of less than 7 months, and an objective response rate below 30%, highlighting the urgent need for more effective therapies. Opatsosumimab has already demonstrated strong efficacy signals and breakthrough therapeutic potential across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC).
Leveraging the conditional activation design of the X-body™ platform, the drug has validated its favorable safety profile in nearly 800 patients. This latest validation in HCC further strengthens the safety foundation for Opatsosumimab as a potential IO2.0 pan-tumor backbone therapy.
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