China-based Chia Tai Tianqing Pharmaceutical has launched a Phase III trial for its TGF-β/PD-1 bifunctional fusion protein TQB2868 in metastatic pancreatic ductal adenocarcinoma (mPDAC), marking the first global Phase III study for this mechanism. The randomised double-blind trial (n=568) will evaluate the first-in-class drug combined with anlotinib and chemotherapy versus placebo plus chemotherapy, with overall survival (OS) as the primary endpoint. Earlier Phase II data presented this year showed a 63.9% objective response rate (ORR) and 86% 6-month progression-free survival (PFS) in 36 evaluable patients, with TGF-β1 suppression exceeding 90% in most cases.

TQB2868 simultaneously blocks PD-1/PD-L1 immune checkpoint signalling and neutralises tumour microenvironment TGF-β, addressing pancreatic cancer's immunosuppressive milieu. Pancreatic cancer remains one of oncology's most lethal malignancies with 5-year survival below 10%, necessitating novel therapies beyond current chemotherapy standards. Chia Tai's candidate could establish a new first-line regimen if Phase III results confirm the promising efficacy and manageable safety (52.5% grade ≥3 adverse events) observed in earlier studies.

PharmCube's NextBiopharm® database shows that Chia Tai beat over 30 competitors in the TGF-β/PD-1/L1 race, including firms such as Hengrui, 3SBio and Merck. Click here to request a free trial for NextBiopharm®.