Eli Lilly has launched Phase III FRAmework-01 trial evaluating FRα antibody-drug conjugate (ADC) LY4170156 in platinum-resistant and platinum-sensitive ovarian cancer patients. The asset acquired through the purchase of Mablink Bioscience demonstrates 45% objective response rate (ORR) in 58 evaluable patients with high-grade serous ovarian cancer across 2-6mg/kg dosing in Phase I studies. The ADC utilises an exatecan topoisomerase I inhibitor payload with drug-to-antibody ratio (DAR) of eight, showing manageable toxicity profile without neurotoxicity or ocular adverse events observed.
The two-part trial compares LY4170156 monotherapy against chemotherapy or mirvetuximab soravtansine in platinum-resistant disease, as well as combined with bevacizumab versus platinum-based chemotherapy in platinum-sensitive setting, with progression-free survival (PFS) as primary endpoint. LY4170156 represents next-generation approach targeting FRα overexpression in ovarian cancer with potential improved therapeutic window over first-generation agents.
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