Kelun's sac-TMT scores win in first-line PD-L1-negative NSCLC population missing from Merck's KEYTRUDA phase 3 program

Kelun-Biotech's sacituzumab tirumotecan (sac-TMT) plus pembrolizumab met its primary endpoint of progression-free survival as first-line treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC in the Phase III OptiTROP-Lung06 trial.

The combination showed a statistically significant and clinically meaningful improvement in PFS versus pembrolizumab plus chemotherapy in PD-L1-negative patients.

This trial is the first Phase III success of an ADC combined with an immune checkpoint inhibitor in this PD-L1-negative, first-line NSCLC setting, addressing a population not covered by Merck’s existing KEYTRUDA-based phase 3 programs.

Meanwhile, Merck’s own KEYTRUDA Plus chemo and monotherapy regimens focus on other PD-L1 expressor groups, leaving a gap in definitive PD-L1-low/negative first-line NSCLC trials, which Kelun’s sac-TMT program now targets.