Group 1 - The core point of the article is that the first patient has successfully received treatment with the drug Opalizumab (LBL-024) in a Phase Ib/II clinical trial for recurrent or metastatic triple-negative breast cancer (TNBC) [1] - The clinical trial is an open-label, multi-center study led by Professor Yin Yongmei from Jiangsu Provincial People's Hospital, aiming to evaluate the efficacy and safety of Opalizumab alone or in combination with albumin-bound paclitaxel for TNBC patients [1] - The drug Opalizumab is a bispecific antibody targeting both PD-L1 and 4-1BB, and it is the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage for extra-pulmonary neuroendocrine carcinoma [2] Group 2 - In two clinical trials in China, Opalizumab has shown encouraging efficacy signals and good safety profiles, whether used as a monotherapy or in combination with chemotherapy for advanced extra-pulmonary neuroendocrine carcinoma [3] - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial and obtained breakthrough therapy designation (BTD) in October 2024 for treating advanced extra-pulmonary neuroendocrine carcinoma [3] - Cancer is a leading cause of morbidity and mortality globally, with breast cancer being the second most common cancer after lung cancer, and TNBC represents a subtype with high malignancy and poor prognosis, accounting for about 15% to 20% of all breast cancer cases [4]
维立志博-B(09887)：维利信?于复发性或转移性三阴性乳腺癌IB/II期试验的首例患者用药