Mersana Therapeutics Announces Upcoming Oral Presentation of Emi-Le Clinical Data at European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress
Mersana Therapeutics (NASDAQ: MRSN) announced upcoming presentation of Phase 1 clinical data for emiltatug ledadotin (Emi-Le) at ESMO Breast Cancer 2025 Annual Congress in Munich. The presentation will focus on clinical activity in patients with triple negative breast cancer (TNBC) who received prior topoisomerase-1 inhibitor ADC treatment.
Initial clinical data from December 13, 2024, showed Emi-Le was generally well-tolerated with a differentiated safety profile. The B7-H4-directed Dolasynthen ADC demonstrated 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 advanced/metastatic breast cancer in patients with HER2-low or HER2-negative disease who received prior topo-1 ADC.
Mersana Therapeutics (NASDAQ: MRSN) ha annunciato la prossima presentazione dei dati clinici di Fase 1 per emiltatug ledadotin (Emi-Le) al Congresso Annuale ESMO sul Cancro al Seno 2025 a Monaco. La presentazione si concentrerà sull'attività clinica in pazienti con carcinoma mammario triplo negativo (TNBC) che hanno ricevuto in precedenza un trattamento con ADC inibitore della topoisomerasi-1.
I dati clinici iniziali del 13 dicembre 2024 hanno mostrato che Emi-Le è stato generalmente ben tollerato con un profilo di sicurezza differenziato. L'ADC Dolasynthen diretto contro B7-H4 ha dimostrato 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 il carcinoma mammario avanzato/metastatico in pazienti con malattia HER2-bassa o HER2-negativa che hanno ricevuto in precedenza un ADC topo-1.
Mersana Therapeutics (NASDAQ: MRSN) anunció la próxima presentación de datos clínicos de Fase 1 para emiltatug ledadotin (Emi-Le) en el Congreso Anual ESMO sobre Cáncer de Mama 2025 en Múnich. La presentación se centrará en la actividad clínica en pacientes con cáncer de mama triple negativo (TNBC) que recibieron previamente tratamiento con ADC inhibidor de topoisomerasa-1.
Los datos clínicos iniciales del 13 de diciembre de 2024 mostraron que Emi-Le fue generalmente bien tolerado con un perfil de seguridad diferenciado. El ADC Dolasynthen dirigido a B7-H4 demostró respuestas objetivas confirmadas en todos los tipos de tumores inscritos. La FDA ha otorgado dos designaciones Fast Track para Emi-Le: una para TNBC avanzado/metastásico y otra para cáncer de mama avanzado/metastásico en pacientes con enfermedad HER2-baja o HER2-negativa que recibieron previamente un ADC topo-1.
Mersana Therapeutics (NASDAQ: MRSN)는 emiltatug ledadotin (Emi-Le)의 1상 임상 데이터 발표를 2025년 뮌헨에서 열리는 ESMO 유방암 연례 학술대회에서 예정하고 있다고 발표했습니다. 발표는 이전에 topoisomerase-1 억제제 ADC 치료를 받은 삼중 음성 유방암(TNBC) 환자에서의 임상 활동에 초점을 맞출 것입니다.
2024년 12월 13일의 초기 임상 데이터는 Emi-Le가 일반적으로 잘 견디며 차별화된 안전성 프로필을 가지고 있음을 보여주었습니다. B7-H4를 표적으로 하는 Dolasynthen ADC는 모든 등록된 종양 유형에서 확인된 객관적 반응을 나타냈습니다. FDA는 Emi-Le에 대해 두 가지 패스트 트랙 지정을 부여했습니다: 하나는 진행성/전이성 TNBC에 대한 것이고, 다른 하나는 이전에 topo-1 ADC 치료를 받은 HER2-저하 또는 HER2-음성 질환 환자의 진행성/전이성 유방암에 대한 것입니다.
Mersana Therapeutics (NASDAQ: MRSN) a annoncé la prochaine présentation des données cliniques de Phase 1 pour emiltatug ledadotin (Emi-Le) lors du Congrès Annuel ESMO sur le Cancer du Sein 2025 à Munich. La présentation se concentrera sur l'activité clinique chez les patients atteints de cancer du sein triple négatif (TNBC) ayant reçu un traitement antérieur par ADC inhibiteur de la topoisomérase-1.
Les données cliniques initiales du 13 décembre 2024 ont montré qu'Emi-Le était généralement bien toléré avec un profil de sécurité différencié. L'ADC Dolasynthen dirigé contre B7-H4 a démontré des réponses objectives confirmées dans tous les types de tumeurs inclus. La FDA a accordé deux désignations Fast Track pour Emi-Le : l'une pour le TNBC avancé/métastatique et l'autre pour le cancer du sein avancé/métastatique chez les patients présentant une maladie HER2-basse ou HER2-négative ayant reçu un ADC topo-1 antérieur.
Mersana Therapeutics (NASDAQ: MRSN) gab die bevorstehende Präsentation von Phase-1-Klinikdaten für emiltatug ledadotin (Emi-Le) beim ESMO-Jahreskongress für Brustkrebs 2025 in München bekannt. Die Präsentation wird sich auf die klinische Aktivität bei Patienten mit dreifach negativem Brustkrebs (TNBC) konzentrieren, die zuvor eine Behandlung mit einem Topoisomerase-1-Inhibitor-ADC erhalten haben.
Die ersten klinischen Daten vom 13. Dezember 2024 zeigten, dass Emi-Le im Allgemeinen gut vertragen wurde und ein differenziertes Sicherheitsprofil aufwies. Der auf B7-H4 gerichtete Dolasynthen-ADC zeigte bestätigte objektive Ansprechen über alle eingeschlossenen Tumorarten hinweg. Die FDA hat für Emi-Le zwei Fast-Track-Zulassungen erteilt: eine für fortgeschrittenes/metastatisches TNBC und eine weitere für fortgeschrittenen/metastatischen Brustkrebs bei Patienten mit HER2-niedriger oder HER2-negativer Erkrankung, die zuvor ein Topo-1-ADC erhalten hatten.
- FDA granted two Fast Track designations for Emi-Le, potentially accelerating approval process
- Phase 1 trial showed confirmed objective responses across all enrolled tumor types
- Demonstrated positive safety profile with differentiated tolerability
- Still in early Phase 1 stage of development
- Efficacy data details and response rates not disclosed
CAMBRIDGE, Mass., April 01, 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 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 Breast Cancer 2025 Annual Congress, which is being held from May 14-17, 2025, in Munich, Germany.
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).
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
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