On April 2, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that Phase 1 dose escalation and backfill cohort clinical data for emiltatug ledadotin (Emi-Le; XMT-1660) will be presented in an oral session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress, which is being held from May 14-17, 2025, in Munich, Germany (Press release, Mersana Therapeutics, APR 1, 2025, View Source [SID1234651761]).
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Oral Presentation Details
Title: Clinical Activity of Emiltatug Ledadotin (Emi-Le), a B7-H4-Directed ADC, in Patients with TNBC who Received at Least One Prior Topoisomerase-1 Inhibitor (Topo-1) ADC
Session Title: Mini Oral Session 1
Date and Time: Thursday, May 15, 2025 from 8:30-10:00 a.m. CEST
Abstract Number: 298MO
Presenter: Erika Hamilton, M.D., Director Breast Cancer Research, Sarah Cannon Research Institute in Nashville, Tennessee
About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in a Phase 1 dose escalation and expansion trial in patients with solid tumors, including breast, endometrial and ovarian cancers as well as adenoid cystic carcinoma type 1. In the initial clinical data that were reported as of a December 13, 2024 data cutoff, Emi-Le was observed to be generally well tolerated with differentiated safety and tolerability profile. Additionally, confirmed objective responses were observed across all enrolled tumor types, including in patients with triple negative breast cancer (TNBC) who had previously been treated with a topoisomerase-1 inhibitor (topo-1) ADC.
The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including TNBC, who have received a prior topo-1 ADC. For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).