On 22 July, Qilu Pharma launched a Phase III trial (n=602) for QLS31905, the world's first CLDN18.2/CD3 bispecific antibody (BsAb) in late-stage development. The study evaluates QLS31905 combined with chemotherapy (nab-paclitaxel/gemcitabine) versus placebo in frontline CLDN18.2-positive pancreatic cancer, with 48-month progression-free survival (PFS) as the primary endpoint. Phase I data showed 18.2% objective response rate (ORR) and 87.9% disease control rate (DCR) in 33 solid tumour patients, including 25% ORR in pancreatic cancer subgroup.

QLS31905 demonstrated manageable safety with no dose-limiting toxicities up to 1200μg/kg. Grade ≥3 adverse events included lymphopenia (21.5%) and cytokine release syndrome (3.8%). The candidate leads 14 global CLDN18.2 BsAb programs in development.

According to PharmCube's NextBiopharm® database, is the most advanced among the 20 CLDN18.2/CD3 therapies currently under development, among which BsAbs are the most numerous modality. Click here to request a free trial for NextBiopharm®.