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Chinese biopharmaceutical announced at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting the preliminary data of the Phase II clinical study of TQB2868 "PD-1/TGF- dual functional fusion protein" in combination with Anlotinib and first-line chemotherapy for metastatic pancreatic ductal adenocarcinoma (mPDAC). As of January 2025, 40 patients with stage IV mPDAC have been enrolled in the study, with 36 evaluable cases. Preliminary data showed that the objective response rate (ORR) of TQB2868 in combination with Anlotinib and AG chemotherapy reached 63.9%, which is 2-3 times that of historical data for AG chemotherapy regimens; the disease control rate (DCR) reached 100%, which is 1.6 times that of AG chemotherapy regimens; the median progression-free survival (PFS) has not reached 6 months yet, with a PFS rate of 86%, which is 2 times that of AG chemotherapy regimens; the median overall survival (OS) has not reached the expected level and is expected to exceed 1 year. In terms of safety, the combination of TQB2868 is well tolerated, with a rate of grade 3 or higher adverse reactions of 52.5%. The company is communicating with the China National Medical Products Administration Drug Evaluation Center (CDE) on the registration Phase III clinical trial of the TQB2868 combination regimen.
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