SKB BIO (06990.HK): ESMO Data for Sac-TMT in Two Phase III Lung Cancer Studies

NewTimeSpace News: On 25 October 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (stock code: 6990) announced that it presented multiple clinical study results at the 2026 ESMO Congress, held in Madrid, Spain from 23 to 27 October, covering its TROP2-directed antibody-drug conjugate (ADC) sac-TMT (佳泰莱) and the B7-H3-directed ADC SKB500.

OptiTROP-Lung06 enrolled 455 patients and evaluated sac-TMT plus pembrolizumab versus platinum doublet chemotherapy plus pembrolizumab in the first-line treatment of PD-L1-negative advanced nonsquamous non-small cell lung cancer (NSCLC); the results were published simultaneously in the New England Journal of Medicine. As at the data cut-off of 9 June 2026, with a median follow-up of 9.7 months, the combination achieved a median progression-free survival of 15.0 months by blinded independent central review versus 5.7 months, reducing the risk of disease progression or death by 51% (HR 0.49; 95% CI 0.36-0.65; P<0.0001). Median duration of response was 13.6 versus 6.8 months, the objective response rate was 50.2% versus 47.3% and the deep response rate 28.8% versus 17.3%; the overall survival hazard ratio was 0.58, with median OS not reached in either arm. The Company said this is the world's first Phase III study of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in first-line driver-negative, PD-L1-negative nonsquamous NSCLC.

OptiTROP-Lung04 enrolled 376 patients and compared sac-TMT monotherapy with platinum doublet chemotherapy in EGFR-mutant nonsquamous NSCLC that had progressed after EGFR tyrosine kinase inhibitor therapy. The prespecified final OS analysis, as at the data cut-off of 6 August 2026 and a median follow-up of 32.3 months, showed median OS of 25.9 versus 17.4 months, an 8.5-month improvement and a 31% reduction in the risk of death (HR 0.69; 95% CI 0.54-0.89; one-sided P=0.0021); the two-year survival rate was 54.1% versus 37.2%.

The congress also featured the final OS analysis of OptiTROP-Breast01 in triple-negative breast cancer, Phase I results of SKB500 in extensive-stage small cell lung cancer, and Phase II results of sac-TMT plus pembrolizumab in urothelial carcinoma and pMMR endometrial cancer. The Company cautioned that the drugs have not been approved for other indications and may not ultimately be successfully developed or commercialised.