China-based Sino Biopharmaceutical Ltd (HKG: 1177) presented data from its Phase II clinical trial (TQB2868-ALTN-II-01) for the PD-1/TGF-β bispecific fusion protein TQB2868 at the 2025 ASCO Annual Meeting. The study evaluated the efficacy and safety of TQB2868 in combination with anlotinib and AG chemotherapy (gemcitabine + nab-paclitaxel) as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC).
Impressive Clinical Results
The trial results demonstrated a significant improvement in treatment outcomes compared to historical data for AG chemotherapy alone. The objective response rate (ORR) for TQB2868 combined with anlotinib and AG chemotherapy was 63.9%, 2-3 times higher than the historical ORR range of 23%-36% for AG chemotherapy. The disease control rate (DCR) reached 100%, which is 1.6 times higher than the 62.3% DCR for AG chemotherapy alone. The median progression-free survival (mPFS) has not yet been reached, with a 6-month PFS rate of 86%, twice as high as the 43.2% for AG chemotherapy. Median overall survival (mOS) has not yet been achieved but is expected to exceed one year.
Potential Impact on Pancreatic Cancer Treatment
These findings highlight the potential of TQB2868 to significantly improve outcomes for patients with metastatic pancreatic ductal adenocarcinoma, a challenging cancer with limited treatment options. The combination therapy’s high response rates and disease control underscore its promise as a new first-line treatment approach, potentially offering substantial benefits over existing therapies.-Fineline Info & Tech
