Kelun-Biotech has reported Phase III OptiTROP-Lung04 results, showing TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan achieved statistically significant overall survival (OS) and progression-free survival (PFS) improvements versus platinum-based chemotherapy in EGFR-mutant non-small cell lung cancer (NSCLC) following tyrosine kinase inhibitor (TKI) failure. The study demonstrated 40% death risk reduction, with median OS not reached versus 17.4 months for chemotherapy, and 51% PFS improvement with 8.3 months versus 4.3 months in the control group. Objective response rate (ORR) reached 60.6% with a manageable safety profile and no interstitial lung disease cases reported.

The trial establishes the first ADC demonstrating dual survival benefit in second-line EGFR-mutant NSCLC, outperforming HER3-directed patritumab deruxtecan's neutral OS results and PD-1 inhibitors' limited efficacy in this population. TROP2 overexpression occurs in 64% of lung adenocarcinomas and 75% of squamous cell carcinomas (SCC), providing selective targeting advantage. Kelun-Biotech's candidate offers a non-chemotherapy monotherapy option with convenient biweekly dosing, addressing unmet needs in TKI-resistant disease where current options yield limited survival extension.

According to PharmCube's NextBiopharm® database, sacituzumab tirumotecan is the second most advanced TROP2 ADC in terms of development, only behind Pfizer and Gilead's sacituzumab govitecan. Click here to request a free trial for NextBiopharm®.