Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. reported median progression-free survival of 15.0 months with sacituzumab tirumotecan plus pembrolizumab, versus 5.7 months with the control regimen, in a Phase 3 trial for advanced lung cancer.
Kelun said the trial met its primary endpoint at a prespecified interim analysis. Researchers randomized patients with PD-L1-negative, non-squamous NSCLC to receive the combination or pembrolizumab plus pemetrexed and platinum chemotherapy; tumors with EGFR mutations or ALK alterations were excluded. Participants had a PD-L1 tumor proportion score below 1% and no EGFR mutations or ALK alterations. The control group received pembrolizumab with pemetrexed and platinum-based chemotherapy.
Blinded independent central review assessed progression-free survival at a hazard ratio of 0.49 (95% confidence interval, 0.36 to 0.65; P<0.0001), Kelun reported. The company described this as a 51% reduction in the risk of progression or death. Median duration of response was 13.6 months in the sac-TMT group and 6.8 months in the control group. Kelun also reported objective response rates of 50.2% and 47.3%, respectively, and deep response rates of 28.8% and 17.3%.
Overall-survival data were not mature at the interim analysis. Median overall survival had not been reached in either group, and the company reported an overall-survival hazard ratio of 0.58 (95% confidence interval, 0.38 to 0.88).
Kelun reported fewer grade 3 or higher treatment-emergent adverse events in the sac-TMT group, along with fewer events leading to dose reduction or permanent discontinuation. Rates of interstitial lung disease or pneumonitis were similar between groups, and the company said no new safety signals emerged.
Professor Caicun Zhou of Shanghai East Hospital, Tongji University, presented the results Sunday at the European Society for Medical Oncology Congress. Kelun said the findings were also published at the same time in The New England Journal of Medicine.
In July, Kelun said it planned to communicate about the results with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The company did not give a date for that communication.
