Kelun-Biotech unveils promising drug trial results at ESMO 2025

Kelun-Biotech announced positive clinical trial results for several innovative drugs, including sac-TMT, trastuzumab deruxtecan, and SKB315, at the 2025 ESMO Congress in Berlin. Two sac-TMT studies were featured as Late Breaking Abstract oral presentations. OptiTROP-Lung04 showed sac-TMT significantly improved PFS to 8.3 months versus 4.3 months for chemotherapy in EGFR-mutated NSCLC, reducing disease progression or death risk by 51% (HR 0.49; P<0.0001). OptiTROP-Breast02 demonstrated sac-TMT extended median PFS to 8.3 months compared to 4.1 months for ICC in HR+/HER2- BC patients (HR 0.35; P<0.0001).

Additionally, trastuzumab deruxtecan was presented as a Late Breaking Abstract oral report, showing a median PFS of 11.1 months versus 4.4 months for T-DM1 in HER2+ metastatic BC (HR 0.39; P<0.0001), with an ORR of 76.9% compared to 53.0%. SKB315, for advanced solid tumors, presented one-year results with an ORR of 37.5% and DCR of 84.4%, a median PFS of 8.2 months, and a median OS of 12.4 months.

These positive findings underscore Kelun-Biotech's progress in oncology, with sac-TMT having received NMPA approval for three indications and trastuzumab deruxtecan for one. SKB315 is in phase 1 trials for advanced solid tumors, including gastric and gastroesophageal junction cancers.