Kelun expands its saci-T efforts again

Merck & Co and Kelun’s TROP2-targeting ADC sacituzumab tirumotecan will begin another pivotal breast cancer study this month, according to a new listing on clinicaltrials.gov. The Chinese trial is sponsored by Kelun, taking that company’s total saci-T phase 3s to eight, in around 3,200 patients. The latest effort, SKB264-III-13, will enrol ER-positive, HER2-negative patients who previously failed on endocrine therapy, but haven’t received chemo. Notably, Kelun has already filed saci-T in China for ER-positive, HER2-negative breast cancer following endocrine “and other systemic treatments”, based on OptiTROP-Breast02; that trial enrolled post-chemo patients. In China the drug is approved for third-line triple-negative breast cancer (based on OptiTROP-Breast01) and EGFR-mutant non-squamous NSCLC, following an EGFR-TKI and platinum chemo (based on the phase 2 OptiTROP-Lung03). Kelun is trying to move saci-T up to the post-TKI setting, with a Chinese filing last year backed by OptiTROP-Lung04. Other trials could expand use into the front line. Still, Kelun’s efforts pale into insignificance beside Merck’s; that group has 14 saci-T phase 3s ongoing in a target 13,000 patients, according to OncologyPipeline. The most recent, TroFuse-032, in neoadjuvant breast cancer, will enrol 2,400 subjects alone.

Kelun-sponsored sacituzumab tirumotecan phase 3 trials

Source: OncologyPipeline & clinicaltrials.gov.