Lilly Says LY4170156 Shows Promising Safety And Anti-Tumor Activity In Phase 1 Ovarian Cancer Trial

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(RTTNews) - Drug major Eli Lilly and Co. (LLY) announced Monday new Phase 1 data showing that its investigational, next-generation folate receptor alpha or FRa antibody-drug conjugate or ADC, LY4170156, demonstrated an encouraging safety profile and anti-tumor activity in ovarian cancer trial.

The positive data was across dose and FRa expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine.

The company noted that a preliminary overall objective response rate or ORR of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg.

LY4170156 is an investigational, next-generation ADC targeting Fra, a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth. FRa is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.

Lilly's FRa targeting ADC is composed of an Fc-silent, FRa specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker.

LY4170156 is currently being studied in patients with ovarian cancer as well as other FRa-expressing solid tumors, NCT06400472.

As of the March 9 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 - 6 mg/kg). Patients received a median of five prior systemic regimens, and 15% were previously treated with mirvetuximab soravtansine.

David Hyman, Chief Medical Officer, Lilly, "We are excited to share these first clinical data for our FRa targeting ADC, demonstrating a promising tolerability and efficacy profile across all FRa expression levels. Based on these results, we believe there is the potential to significantly expand the number of ovarian cancer patients who could benefit from a FRa ADC. We are now focused on rapidly advancing this potential new medicine into registrational Phase 3 clinical trials."

The company plans to present these data in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting.

On the NYSE, Eli Lilly shares are currently trading at $738.63, up 0.10%.