Kelun-Biotech's sacituzumab tirumotecan (sac-TMT), combined with Merck's Keytruda, improved progression-free survival in the Phase III OptiTROP-Lung05 trial for advanced NSCLCthe first ADC-checkpoint inhibitor combo to do so.
Why It Matters To Oncology
▪ First late-stage data showing an ADC and checkpoint inhibitor combo outperforms immunotherapy alone in previously untreated NSCLC.
▪ Supports broader use of TROP2-targeting ADCs beyond breast cancer and sets a precedent for combination regimens in solid tumors.
▪ OptiTROP-Lung05 and Lung04 trials highlight sac-TMT's efficacy across multiple NSCLC subtypes, including EGFR-mutant disease.
The Financials
▪ Merck holds ex-China rights to sac-TMT and recently secured $700M from Blackstone Life Sciences to fuel its global program.
▪ Sac-TMT is already approved in China for two NSCLC indications and triple-negative breast cancer.
▪ Development includes 15 Phase III trials across six tumor types.
What They're Saying
▪ Kelun says the combo achieved statistically significant and clinically meaningful PFS improvement, with a positive OS trend.
▪ Recent ESMO data showed sac-TMT monotherapy reduced risk of progression or death by 51% versus chemo in EGFR-mutated NSCLC.
What's Next
▪ Kelun plans to discuss regulatory filing for sac-TMT in frontline NSCLC with Chinese authorities.
▪ Continued expansion of sac-TMT's clinical program; Merck and Kelun's evolving partnership is tracked closely by analysts.