Merck (NYSE: MRK) and Kelun-Biotech (HKEX: 6990) report sac-TMT benefit in PD-L1-negative lung cancer
A Chinese Phase 3 study supports replacing chemotherapy with an ADC alongside Keytruda in a defined population.
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Merck and Kelun-Biotech's sacituzumab tirumotecan, or sac-TMT, produced a substantial progression-free survival improvement in the Chinese OptiTROP-Lung06 study. Patients had previously untreated non-small-cell lung cancer with PD-L1 expression below 1%.
Sac-TMT combined with Keytruda achieved median progression-free survival of 15 months, compared with 5.7 months for Keytruda plus chemotherapy. The hazard of progression or death was reduced by 51%.
Overall-survival data remained immature. A favourable numerical trend at this stage should not be presented as a confirmed survival advantage.
The result is relevant because the study directly tests a different treatment partner for immunotherapy in a biomarker-defined group. It gives the programme another potential use beyond later-line treatment.
For international commercial planning, the next questions concern the broader development package and regulatory requirements. Strong results from one regional trial can inform those discussions, but they do not by themselves establish worldwide approval or equivalent outcomes in every treatment setting.
Source: Fierce Pharma OptiTROP-Lung06 reporting, 25 October.