Mersana Therapeutics Announces Upcoming Emi-Le Oral and Poster Presentations at ASCO 2025 Annual Meeting
Mersana Therapeutics (NASDAQ: MRSN) announced upcoming presentations of their B7-H4-directed Dolasynthen ADC, emiltatug ledadotin (Emi-Le), at the ASCO 2025 Annual Meeting from May 30-June 3, 2025. The presentations include:
1. An oral presentation on Phase 1 dose escalation data across tumor types by Dr. Erika Hamilton on June 2, 2025
2. A poster presentation on the ongoing Phase 1 dose expansion trial in triple negative breast cancer (TNBC) patients by Dr. Hyo Han
Initial clinical data from December 2024 showed Emi-Le was generally well tolerated with confirmed objective responses across all enrolled tumor types. The FDA has granted two Fast Track designations for Emi-Le: one for advanced/metastatic TNBC and another for HER2 low/negative breast cancer patients who received prior topo-1 ADC treatment.
Mersana Therapeutics (NASDAQ: MRSN) ha annunciato le prossime presentazioni del loro ADC Dolasynthen diretto contro B7-H4, emiltatug ledadotin (Emi-Le), al ASCO 2025 Annual Meeting che si terrà dal 30 maggio al 3 giugno 2025. Le presentazioni includono:
1. Una presentazione orale sui dati di escalation della dose in Fase 1 su diversi tipi di tumore a cura della Dott.ssa Erika Hamilton il 2 giugno 2025
2. Una presentazione poster sullo studio in corso di espansione della dose in Fase 1 su pazienti con carcinoma mammario triplo negativo (TNBC) a cura del Dott. Hyo Han
I dati clinici iniziali di dicembre 2024 hanno mostrato che Emi-Le è generalmente ben tollerato, con risposte obiettive confermate in tutti i tipi di tumore arruolati. La FDA ha concesso due designazioni Fast Track per Emi-Le: una per il TNBC avanzato/metastatico e un'altra per pazienti con carcinoma mammario HER2 basso/negativo che hanno ricevuto precedentemente un trattamento ADC topo-1.
Mersana Therapeutics (NASDAQ: MRSN) anunció próximas presentaciones de su ADC Dolasynthen dirigido contra B7-H4, emiltatug ledadotin (Emi-Le), en el ASCO 2025 Annual Meeting que se realizará del 30 de mayo al 3 de junio de 2025. Las presentaciones incluyen:
1. Una presentación oral sobre datos de escalada de dosis en fase 1 en distintos tipos de tumores por la Dra. Erika Hamilton el 2 de junio de 2025
2. Una presentación en póster sobre el ensayo en curso de expansión de dosis en fase 1 en pacientes con cáncer de mama triple negativo (TNBC) por el Dr. Hyo Han
Los datos clínicos iniciales de diciembre de 2024 mostraron que Emi-Le fue generalmente bien tolerado, con respuestas objetivas confirmadas en todos los tipos de tumores incluidos. La FDA otorgó dos designaciones Fast Track para Emi-Le: una para TNBC avanzado/metastásico y otra para pacientes con cáncer de mama HER2 bajo/negativo que recibieron tratamiento previo con ADC topo-1.
Mersana Therapeutics (NASDAQ: MRSN)는 2025년 5월 30일부터 6월 3일까지 개최되는 ASCO 2025 연례 회의에서 B7-H4를 표적하는 Dolasynthen ADC, emiltatug ledadotin (Emi-Le)의 발표 일정을 발표했습니다. 발표 내용은 다음과 같습니다:
1. 2025년 6월 2일 Dr. Erika Hamilton이 진행하는 다양한 종양 유형에 대한 1상 용량 증량 데이터 구두 발표
2. Dr. Hyo Han이 진행하는 삼중음성유방암(TNBC) 환자를 대상으로 한 1상 용량 확장 임상시험 포스터 발표
2024년 12월 초기 임상 데이터에 따르면 Emi-Le는 전반적으로 내약성이 우수하며 등록된 모든 종양 유형에서 객관적 반응이 확인되었습니다. FDA는 Emi-Le에 대해 두 가지 Fast Track 지정을 부여했습니다: 진행성/전이성 TNBC와 이전에 topo-1 ADC 치료를 받은 HER2 낮음/음성 유방암 환자 대상입니다.
Mersana Therapeutics (NASDAQ : MRSN) a annoncé les prochaines présentations de leur ADC Dolasynthen dirigé contre B7-H4, emiltatug ledadotin (Emi-Le), lors du ASCO 2025 Annual Meeting qui se tiendra du 30 mai au 3 juin 2025. Les présentations comprennent :
1. Une présentation orale sur les données d’escalade de dose en phase 1 à travers différents types de tumeurs par le Dr Erika Hamilton le 2 juin 2025
2. Une présentation par poster sur l’essai en cours d’expansion de dose en phase 1 chez des patientes atteintes de cancer du sein triple négatif (TNBC) par le Dr Hyo Han
Les données cliniques initiales de décembre 2024 ont montré qu’Emi-Le était généralement bien toléré, avec des réponses objectives confirmées dans tous les types de tumeurs inclus. La FDA a accordé deux désignations Fast Track à Emi-Le : une pour le TNBC avancé/métastatique et une autre pour les patientes atteintes de cancer du sein HER2 bas/négatif ayant reçu un traitement antérieur par ADC topo-1.
Mersana Therapeutics (NASDAQ: MRSN) kündigte bevorstehende Präsentationen ihres B7-H4-gerichteten Dolasynthen-ADC, emiltatug ledadotin (Emi-Le), auf dem ASCO 2025 Annual Meeting vom 30. Mai bis 3. Juni 2025 an. Die Präsentationen umfassen:
1. Eine mündliche Präsentation zu Phase-1-Dosiseskalationsdaten über verschiedene Tumortypen von Dr. Erika Hamilton am 2. Juni 2025
2. Eine Posterpräsentation zur laufenden Phase-1-Dosis-Erweiterungsstudie bei Patientinnen mit triple-negativem Brustkrebs (TNBC) von Dr. Hyo Han
Erste klinische Daten aus Dezember 2024 zeigten, dass Emi-Le allgemein gut verträglich ist und bestätigte objektive Ansprechraten bei allen eingeschlossenen Tumortypen vorliegen. Die FDA hat Emi-Le zwei Fast-Track-Designationen gewährt: eine für fortgeschrittenen/metastasierten TNBC und eine weitere für HER2-niedrig/negativ Brustkrebspatientinnen, die zuvor eine topo-1-ADC-Behandlung erhalten haben.
- FDA granted two Fast Track designations for Emi-Le, potentially accelerating approval process
- Initial clinical data showed confirmed objective responses across all enrolled tumor types
- Demonstrated efficacy in TNBC patients previously treated with topo-1 ADC, indicating potential for second-line treatment
- Still in early Phase 1 clinical trials, indicating long path to potential commercialization
- Multiple competitors in the ADC space for breast cancer treatment
CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- 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, today announced that the following presentations related to emiltatug ledadotin (Emi-Le; XMT-1660), Mersana’s B7-H4-directed Dolasynthen ADC, will be given at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30-June 3, 2025 at McCormick Place, Chicago, IL:
Oral Presentation Details
- Title: Initial Phase 1 Dose Escalation Data for Emiltatug Ledadotin (Emi-Le), a Novel B7-H4-Directed Dolasynthen Antibody-Drug Conjugate
- Rapid Oral Session Title: Developmental Therapeutics
- Date and Time: Monday, June 2, 2025 from 8:00-9:30 a.m. CT
- Abstract Number: 3009
- Presenter: Erika Hamilton, M.D., Director Breast Cancer Research Program, Sarah Cannon Research Institute in Nashville, Tennessee
This presentation will include clinical data from dose escalation and backfill cohorts across tumor types from the ongoing Phase 1 clinical trial of Emi-Le.
Poster Presentation Details
- Title: Emiltatug Ledadotin (Emi-Le): A B7-H4-Directed Dolasynthen Antibody-Drug Conjugate (ADC) Being Investigated in Phase 1 Dose Expansion in Patients with Triple Negative Breast Cancer Who Received at Least One Prior Topoisomerase-1 Inhibitor ADC
- Poster Session Title: Breast Cancer - Metastatic
- Date and Time: Monday, June 2, 2025 from 9:00-12:00 p.m. CT
- Abstract Number: TPS1141
- Presenter: Hyo Han, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
This “trial-in-progress” presentation will focus on the design of the ongoing expansion portion of Mersana’s Phase 1 clinical trial of Emi-Le that is actively enrolling patients with triple negative breast cancer (TNBC) who have received one to four prior treatment lines, including at least one topoisomerase-1 inhibitor ADC.
Additionally, as previously announced, an oral presentation regarding Emi-Le will be given at the ESMO Breast Cancer 2025 Annual Congress in Munich, Germany on Thursday, May 15, 2025. This presentation will focus on TNBC clinical data from dose escalation and backfill cohorts from the Phase 1 clinical trial of Emi-Le.
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).
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes Emi-Le (emiltatug ledadotin; XMT-1660), a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.
Contact:
Jason Fredette
617-498-0020
jason.fredette@mersana.com
FAQ
What are the key findings from Mersana's (MRSN) Emi-Le Phase 1 trial as of December 2024?
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