Merus Announces Abstract Accepted for Presentation at the 2025 ASCO® Annual Meeting
Merus N.V. (Nasdaq: MRUS) announced the acceptance of an abstract for presentation at the 2025 ASCO Annual Meeting in Chicago. The presentation will feature updated interim clinical data from their phase 2 trial of petosemtamab with pembrolizumab as first-line treatment for PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The poster presentation will include data on the complete 45-patient dataset, building upon previously presented early clinical efficacy and safety data from ASCO 2024. According to CEO Bill Lundberg, petosemtamab shows potential as a first and best-in-class treatment for r/m HNSCC, demonstrating substantial clinical activity superior to historical controls across ORR, PFS, and OS metrics.
The presentation is scheduled for June 2, 2025, and Merus will host an investor conference call on May 22, 2025, to discuss the full data set.
Merus N.V. (Nasdaq: MRUS) ha annunciato l'accettazione di un abstract per la presentazione al 2025 ASCO Annual Meeting di Chicago. La presentazione includerà dati clinici intermedi aggiornati del loro studio di fase 2 su petosemtamab con pembrolizumab come trattamento di prima linea per il carcinoma squamoso della testa e del collo ricorrente/metastatico PD-L1+ (HNSCC).
La presentazione poster comprenderà i dati completi di un dataset di 45 pazienti, ampliando i dati preliminari sull'efficacia clinica e la sicurezza già presentati all'ASCO 2024. Secondo il CEO Bill Lundberg, petosemtamab mostra potenzialità come trattamento di prima scelta e best-in-class per r/m HNSCC, evidenziando un'attività clinica significativa superiore ai controlli storici nei parametri ORR, PFS e OS.
La presentazione è prevista per il 2 giugno 2025, mentre Merus terrà una conference call con gli investitori il 22 maggio 2025 per discutere l'intero dataset.
Merus N.V. (Nasdaq: MRUS) anunció la aceptación de un resumen para presentación en la Reunión Anual ASCO 2025 en Chicago. La presentación incluirá datos clínicos interinos actualizados de su ensayo de fase 2 con petosemtamab y pembrolizumab como tratamiento de primera línea para carcinoma escamoso recurrente/metastásico de cabeza y cuello PD-L1+ (HNSCC).
La presentación en póster incluirá datos completos de un conjunto de 45 pacientes, ampliando los datos preliminares de eficacia clínica y seguridad presentados en ASCO 2024. Según el CEO Bill Lundberg, petosemtamab muestra potencial como tratamiento de primera línea y best-in-class para r/m HNSCC, demostrando una actividad clínica sustancial superior a los controles históricos en las métricas ORR, PFS y OS.
La presentación está programada para el 2 de junio de 2025 y Merus realizará una llamada con inversores el 22 de mayo de 2025 para discutir el conjunto completo de datos.
Merus N.V. (나스닥: MRUS)는 시카고에서 열리는 2025 ASCO 연례회의에서 발표할 초록이 승인되었다고 발표했습니다. 이번 발표에서는 PD-L1+ 재발/전이성 두경부 편평세포암(HNSCC)에 대한 1차 치료제로서 페토셈타맙과 펨브롤리주맙 병용의 2상 임상시험 중간 업데이트 데이터를 소개할 예정입니다.
포스터 발표에는 총 45명의 환자 데이터를 포함하며, ASCO 2024에서 발표된 초기 임상 효능 및 안전성 데이터를 확장한 내용입니다. CEO 빌 런드버그에 따르면, 페토셈타맙은 r/m HNSCC에 대해 1차 치료제이자 최고 수준(best-in-class) 치료제로서 잠재력을 보이며, ORR, PFS, OS 지표에서 과거 대비 우수한 임상 활동성을 입증했다고 합니다.
발표는 2025년 6월 2일로 예정되어 있으며, Merus는 2025년 5월 22일 투자자 컨퍼런스 콜을 열어 전체 데이터 세트를 논의할 계획입니다.
Merus N.V. (Nasdaq : MRUS) a annoncé l'acceptation d'un résumé pour une présentation lors du 2025 ASCO Annual Meeting à Chicago. La présentation portera sur des données cliniques intermédiaires mises à jour de leur essai de phase 2 sur le petosemtamab en association avec le pembrolizumab en traitement de première ligne du carcinome épidermoïde récurrent/métastatique de la tête et du cou PD-L1+ (HNSCC).
La présentation sous forme d'affiche comprendra les données complètes d'un ensemble de 45 patients, s'appuyant sur les données initiales d'efficacité clinique et de sécurité présentées lors de l'ASCO 2024. Selon le PDG Bill Lundberg, le petosemtamab montre un potentiel en tant que traitement de première ligne et best-in-class pour le r/m HNSCC, démontrant une activité clinique significative supérieure aux contrôles historiques sur les critères ORR, PFS et OS.
La présentation est prévue pour le 2 juin 2025, et Merus organisera une conférence téléphonique avec les investisseurs le 22 mai 2025 pour discuter de l'intégralité des données.
Merus N.V. (Nasdaq: MRUS) gab die Annahme eines Abstracts für eine Präsentation auf dem 2025 ASCO Annual Meeting in Chicago bekannt. Die Präsentation wird aktualisierte Zwischenberichte aus der Phase-2-Studie von Petosemtamab mit Pembrolizumab als Erstlinientherapie für PD-L1+ rezidivierende/metastasierende Plattenepithelkarzinome des Kopf- und Halsbereichs (HNSCC) enthalten.
Die Posterpräsentation wird Daten des vollständigen Datensatzes von 45 Patienten umfassen und baut auf zuvor auf der ASCO 2024 vorgestellten frühen Daten zur klinischen Wirksamkeit und Sicherheit auf. Laut CEO Bill Lundberg zeigt Petosemtamab Potenzial als erstklassige Erstlinientherapie für r/m HNSCC und demonstriert eine deutlich bessere klinische Aktivität im Vergleich zu historischen Kontrollen bei den Kennzahlen ORR, PFS und OS.
Die Präsentation ist für den 2. Juni 2025 geplant, und Merus wird am 22. Mai 2025 eine Telefonkonferenz für Investoren abhalten, um den vollständigen Datensatz zu besprechen.
- Phase 2 trial demonstrates substantial clinical activity superior to historical controls
- Strong performance across multiple metrics (ORR, PFS, OS) in overall population and key subgroups
- Potential to become new standard of care for r/m HNSCC treatment
- Abstract presentation downgraded to poster session due to initial data
Insights
Merus's petosemtamab shows promising phase 2 results in head/neck cancer; full data pending ASCO presentation with potential practice-changing implications.
The upcoming ASCO presentation represents a critical milestone for Merus's lead candidate petosemtamab. The abstract acceptance for their 45-patient dataset combining petosemtamab with pembrolizumab in first-line recurrent/metastatic HNSCC signals progression of this promising program.
What's particularly noteworthy is management's emphasis on efficacy demonstrated across multiple endpoints (ORR, PFS, OS) both in the overall population and in key subgroups stratified by HPV status and PD-L1 expression. This consistency across endpoints suggests robust activity rather than isolated positive signals.
Head and neck cancer represents a challenging therapeutic area with effective options, particularly for recurrent/metastatic disease. Current first-line standards typically involve pembrolizumab either as monotherapy or combined with chemotherapy based on PD-L1 status. The development of a bispecific antibody approach that potentially enhances pembrolizumab efficacy could address significant unmet needs.
The advancement to phase 3 trials indicates internal confidence in the data generated thus far. While the poster (rather than oral) presentation format might initially raise questions, the CEO's explanation attributes this to data in the original abstract submission rather than concerns about efficacy signals in the complete dataset.
This interim phase 2 data will provide crucial insights regarding the potential positioning of petosemtamab in the treatment landscape. If the data supports management's characterization, this could indeed represent a meaningful advancement for patients with this aggressive malignancy.
Merus's encouraging phase 2 data for petosemtamab advancing to phase 3 signals potential pipeline validation and market opportunity in head/neck cancer.
This abstract acceptance represents both a clinical and strategic milestone for Merus's development program. The company's confidence in petosemtamab's efficacy data is evident in their decision to host an investor call immediately following the abstract release - typically a signal that management believes the data warrants immediate discussion.
The characterization of results as showing "substantial clinical activity superior to historical controls" across multiple endpoints suggests meaningful efficacy signals, though investors should await the actual data presentation for independent verification of these claims. The consistency reported across both the overall population and subgroups is particularly encouraging as it suggests broad applicability.
From a pipeline perspective, positive data would significantly de-risk the company's multispecific antibody platform technology. Petosemtamab represents one of Merus's most advanced clinical candidates, and successful demonstration of its efficacy could validate the company's technological approach and development strategy.
The advancement to phase 3 trials represents a crucial value inflection point. Head and neck cancer represents a substantial market opportunity with approximately 65,000 new cases diagnosed annually in the US alone. First-line therapy for recurrent/metastatic disease represents a significant commercial opportunity if efficacy data proves practice-changing.
While the company's commentary is decidedly positive, investors should note that the full efficacy data remains to be presented. The upcoming investor call on May 22nd will provide crucial insights into the complete dataset and potentially offer a clearer picture of petosemtamab's competitive positioning and market potential in the HNSCC treatment landscape.
- Petosemtamab in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC interim clinical data selected for poster presentation
- Conference call on Thursday, May 22 at 5:30 p.m. ET to discuss full ASCO® data set
UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today announced the acceptance of an abstract for presentation at the 2025 American Society of Clinical Oncology® (ASCO®) Annual Meeting, being held in Chicago, Illinois on May 30- June 3, 2025.
An updated analysis of the interim clinical data from the phase 2 trial of petosemtamab with pembrolizumab as 1L treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) will be presented in a poster at 2025 ASCO®. The presentation will include data on the entire 45 patient dataset and follows the early clinical efficacy and encouraging safety data previously presented at 2024 ASCO®.
“We continue to believe that petosemtamab has the potential to be a first and best-in-class, practice-changing medicine for the treatment of r/m HNSCC. While the decision to have a poster presentation at 2025 ASCO® was based on the limited data included in the submitted abstract, we are very much looking forward to sharing the robust updated interim phase 2 data, on the entire 45 patient data set, on the upcoming investor conference call and in our presentation at the conference,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “We believe petosemtamab continues to demonstrate substantial clinical activity superior to historical controls, based on the magnitude and consistency of efficacy, not just on one endpoint, but across ORR, PFS and OS in the overall population and within important subgroups of HPV disease and PD-L1 expression levels. On the back of these data, and the strong execution of our phase 3 trials, we believe petosemtamab has the potential to become a new standard of care for r/m HNSCC.”
Poster presentation:
Title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Abstract #: 6024
Poster Board: 432
Session Title: Head and Neck Cancer
Session Date and Time: June 2, 2025, 9:00-12:00 CT
The abstracts will be available on the ASCO® website on May 22, 2025 at 5:00 p.m. ET. The full presentation will be available on the Merus website at the start of the session.
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Thursday, May 22, 2025 at 5:30 p.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.
Date & Time: May 22, 2025 at 5:30 p.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: (800) 715-9871 / International: (646) 307-1963
Conference ID: 7517301 or Merus NV call
About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics® low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.
About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by
1 Sung et al. CA Cancer J Clin, 71:209-49, 2021; 2 Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6(1):92, 2020
About LiGeR-HN1
LiGeR-HN1, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab, compared to pembrolizumab in 1L PD-L1+ r/m HNSCC patients. The trial is open to adult patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.
About Merus N.V.
Merus is an oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding the clinical development of our clinical candidates, including petosemtamab, future clinical trial results or interim data, clinical activity and safety profile, and development plans in the on-going trials and described in forthcoming posters or presentations; our belief that petosemtamab has the potential to be a first and best-in-class, practice-changing medicine for the treatment of r/m HNSCC; our sharing the robust updated interim phase 2 data, on the entire 45 patient data set, on the upcoming investor conference call and in our presentation at the conference; our belief that petosemtamab continues to demonstrate substantial clinical activity superior to historical controls, based on the magnitude and consistency of efficacy, not just on one endpoint, but across ORR, PFS and OS in the overall population and within important subgroups of HPV disease and PD-L1 expression levels; our execution of our phase 3 trials; and our belief that petosemtamab has the potential to become a new standard of care for r/m HNSCC. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the volatility in the global economy, including global instability, including the ongoing conflicts in Europe and the Middle East; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2024, filed with the Securities and Exchange Commission, or SEC, on February 27, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
Investor and Media Inquiries: Sherri Spear Merus N.V. SVP Investor Relations and Strategic Communications 617-821-3246 s.spear@merus.nl Kathleen Farren Merus N.V. Director Investor Relations and Corporate Communications 617-230-4165 k.farren@merus.nl
FAQ
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