Movement Alert|Kelun-Biotech Rises 10.8% in Regular Trading, Core TROP2 ADC Achieves Phase III Primary Endpoint in PD-L1 Negative NSCLC

Market Focus
Jul 15

On July 15, Kelun-Biotech (06990.HK) rose 10.8% in regular trading to HK$552.0, with turnover of HK$465 million.

The rally was driven by the company announcing that its core product sacituzumab tirumotecan (sac-TMT) combined with pembrolizumab achieved the primary endpoint of progression-free survival (PFS) in the Phase III OptiTROP-Lung06 study for first-line treatment of PD-L1 negative locally advanced or metastatic non-squamous NSCLC. This marks the first global Phase III study where an ADC combined with an immune checkpoint inhibitor achieved a primary endpoint in first-line treatment of driver-gene negative, PD-L1 negative non-squamous NSCLC. The study also showed an OS benefit trend, with safety consistent with prior reports and no new signals observed.

This result expands coverage beyond the previously reported PD-L1 positive population from the OptiTROP-Lung05 study presented at ASCO. The company plans to communicate with NMPA regarding regulatory next steps and currently has nine registrational studies underway in China.

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