Kelun claims a saci-T win in first-line lung
Kelun is pushing deeper into the lung cancer space after announcing that its Merck & Co-partnered TROP2-targeting ADC sacituzumab tirumotecan has succeeded in the OptiTROP-Lung05 study in first-line NSCLC. The Chinese phase 3 trial, in patients with PD-L1 expression ≥1%, met its primary endpoint of progression-free survival with saci-T plus Keytruda, versus Keytruda alone. The company also reported a positive trend in overall survival, though details remain limited for now. Still, the study's control arm does not reflect the most used standard of care in this setting; that is Keytruda plus chemotherapy. Notably, Kelun is also running the OptiTROP-Lung06 trial, testing saci-T plus Keytruda, versus Keytruda plus chemo, which is expected to read out next year. Kelun's partner Merck has a slew of global registrational saci-T trials under way, but none in the first-line PD-L1 ≥1% NSCLC setting, according to OncologyPipeline. However, Merck is running the TroFuse-007 trial in patients with PD-L1 expression ≥50%. Gilead is exploring the same indication in the Evoke-03 trial of its TROP2 ADC Trodelvy, but AstraZeneca is taking a different approach, testing its rival Datroway in PD-L1 <50% expressers in Tropion-Lung07, and in ≥50% expressers in Tropion-Lung08.
Selected Keytruda + saci-t trials
| Trial | Setting | Regimen | Note |
|---|---|---|---|
| OptiTROP-Lung05 | 1st-line PD-L1 ≥1% NSCLC | + Keytruda, vs Keytruda | Toplined positive on PFS Nov 2025, plus positive OS trend |
| OptiTROP-Lung06 | 1st-line PD-L1 ≥1% NSCLC | + Keytruda, vs Keytruda + chemotherapy | Primary completion Dec 2026 |
| TroFuse-007 | 1st-line PD-L1 ≥50% NSCLC | + Keytruda, vs Keytruda | Primary completion Jan 2028 |
Source: OncologyPipeline.
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