Merus’ Petosemtamab with Pembrolizumab Interim Data Demonstrates Robust Efficacy and Durability in 1L PD-L1+ r/m HNSCC
- 79% overall survival rate at 12 months - 9 months median progression-free survival - Responses observed across PD-L1 levels - 14 responding patients still on treatment
The treatment combination was generally well-tolerated, with Grade ≥3 treatment-emergent adverse events occurring in 60% of patients. Infusion-related reactions were reported in 38% of patients, mainly during first infusion. The data suggests potential superiority over pembrolizumab monotherapy, positioning petosemtamab as a possible future standard of care in head and neck cancer. Merus expects to share top-line interim readout of phase 3 trials in 2026.
- 79% di sopravvivenza globale a 12 mesi
- 9 mesi di sopravvivenza libera da progressione mediana
- Risposte osservate indipendentemente dai livelli di PD-L1
- 14 pazienti in risposta ancora in trattamento
La combinazione terapeutica è stata generalmente ben tollerata, con eventi avversi di grado ≥3 correlati al trattamento nel 60% dei pazienti. Reazioni correlate all'infusione sono state riportate nel 38% dei pazienti, principalmente durante la prima infusione. I dati suggeriscono una possibile superiorità rispetto alla monoterapia con pembrolizumab, posizionando petosemtamab come un potenziale futuro standard di cura nel cancro della testa e del collo. Merus prevede di condividere i risultati intermedi principali degli studi di fase 3 nel 2026.
- 79% de tasa de supervivencia global a 12 meses
- 9 meses de supervivencia libre de progresión mediana
- Respuestas observadas en todos los niveles de PD-L1
- 14 pacientes respondedores aún en tratamiento
La combinación de tratamiento fue generalmente bien tolerada, con eventos adversos relacionados con el tratamiento de grado ≥3 en el 60% de los pacientes. Las reacciones relacionadas con la infusión se reportaron en el 38% de los pacientes, principalmente durante la primera infusión. Los datos sugieren una posible superioridad sobre la monoterapia con pembrolizumab, posicionando a petosemtamab como un posible estándar de cuidado futuro en el cáncer de cabeza y cuello. Merus espera compartir los resultados interinos principales de los ensayos de fase 3 en 2026.
- 12개월 전체 생존율 79%
- 무진행 생존기간 중앙값 9개월
- PD-L1 수준과 관계없이 반응 관찰
- 14명의 반응 환자가 여전히 치료 중
치료 병용요법은 전반적으로 잘 견뎌졌으며, 60% 환자에서 3등급 이상 치료 관련 이상반응이 발생했습니다. 주입 관련 반응은 주로 첫 주입 시 38% 환자에서 보고되었습니다. 이 데이터는 pembrolizumab 단독요법 대비 우수성을 시사하며, petosemtamab이 두경부암의 미래 표준 치료가 될 가능성을 보여줍니다. Merus는 2026년에 3상 시험의 주요 중간 결과를 공유할 예정입니다.
- 79% de taux de survie globale à 12 mois
- Survie sans progression médiane de 9 mois
- Réponses observées quel que soit le niveau de PD-L1
- 14 patients en réponse encore sous traitement
La combinaison thérapeutique a été généralement bien tolérée, avec des événements indésirables liés au traitement de grade ≥3 chez 60% des patients. Des réactions liées à la perfusion ont été rapportées chez 38% des patients, principalement lors de la première perfusion. Ces données suggèrent une possible supériorité par rapport à la monothérapie par pembrolizumab, positionnant petosemtamab comme un futur standard de soins dans le cancer de la tête et du cou. Merus prévoit de communiquer les résultats intermédiaires principaux des essais de phase 3 en 2026.
- 79% Gesamtüberlebensrate nach 12 Monaten
- Medianes progressionsfreies Überleben von 9 Monaten
- Ansprechen über alle PD-L1-Level hinweg beobachtet
- 14 ansprechende Patienten noch in Behandlung
Die Behandlungskombination wurde insgesamt gut vertragen, mit therapiebedingten Nebenwirkungen ab Grad 3 bei 60% der Patienten. Infusionsbedingte Reaktionen traten bei 38% der Patienten auf, hauptsächlich während der ersten Infusion. Die Daten deuten auf eine mögliche Überlegenheit gegenüber Pembrolizumab-Monotherapie hin und positionieren petosemtamab als potenziellen zukünftigen Behandlungsstandard bei Kopf-Hals-Krebs. Merus plant, die wichtigsten Zwischenergebnisse der Phase-3-Studien im Jahr 2026 zu veröffentlichen.
- Strong 63% response rate in phase 2 trial, including 6 complete responses
- Impressive 79% overall survival rate at 12 months
- Robust 9-month median progression-free survival
- Treatment combination showed no significant overlapping toxicities with pembrolizumab
- Potential to become new standard of care in head and neck cancer
- Grade ≥3 adverse events occurred in 60% of patients
- Infusion-related reactions reported in 38% of patients
- Phase 3 trial results not expected until 2026
Insights
Petosemtamab with pembrolizumab shows impressive 63% response rate and 79% one-year survival in head/neck cancer, significantly outperforming standard treatment.
The interim data from Merus's phase 2 trial of petosemtamab (a bispecific EGFR x LGR5 antibody) combined with pembrolizumab in first-line PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) demonstrates remarkable efficacy. The confirmed overall response rate of
What's particularly impressive is the durability of these responses. With median follow-up of 14.3 months, median duration of response hasn't yet been reached, suggesting lasting benefit. The
The therapy shows efficacy across PD-L1 expression levels, though higher PD-L1 expressors (CPS ≥20) demonstrated better response rates (
Perhaps most telling is that 14 responders remained on treatment at data cutoff, indicating both tolerability and durability. The company's accelerated enrollment in phase 3 trials suggests confidence, with potential top-line readouts in 2026 that could position petosemtamab as a new standard of care in HNSCC - a difficult-to-treat cancer with poor prognosis where new options are desperately needed.
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- Conference Call on Thursday, May 22 at 5:30 p.m. ET
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 22, 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 interim clinical data as of a February 27, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab. These data will be presented by Dr. Carla M. L. van Herpen M.D. Ph.D., Radboud University Medical Center, Nijmegen, Netherlands at the 2025 American Society of Clinical Oncology® (ASCO®) Annual Meeting on Monday, June 2 at 9 a.m. - 12:00 p.m. CT.
“By essentially every metric, we believe these interim data are significantly better than pembrolizumab monotherapy, the control arm of our ongoing phase 3 trial, and underscores the opportunity petosemtamab holds to become a new standard of care, if approved, in head and neck cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Additionally, we believe our execution is outstanding with rapid site initiation. We are looking forward to potentially sharing top line interim readout of one or both of our phase 3 trials in 2026.”
“Head and neck squamous cell carcinoma is associated with a poor prognosis and high mortality rate, and there remains a need for new treatment options for patients,” added Dr. van Herpen. “In my clinic, I have witnessed firsthand profound tumor shrinkage with petosemtamab administration, and the efficacy results petosemtamab has shown thus far in combination with the current standard of care, pembrolizumab. I’m excited by the impressive ORR and durability of those responses, and what these results, if replicated more broadly could mean for the future of our practice in head and neck cancer.”
Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors
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
Observations in the presentation include as of a February 27, 2025 data cutoff date:
- 45 patients (pts) were treated
- The efficacy evaluable population consisted of 43 patients who were treated (with one or more doses) as of the data cutoff date and either ≥1 post-baseline tumor assessment, or discontinued early due to disease progression or death
- Median follow up of 14.3 months for the 45 patients
- In 43 evaluable patients:
- Confirmed overall response rate:
63% (27/43,95% CI: 49-75), including 6 complete responses, 21 partial responses by Response Evaluation Criteria in Solid Tumors v1.1. per investigator assessment, including:- 4 of 8 patients with HPV associated cancer responded
- Responses observed across PD-L1 levels (CPS 1-19:
47% [8/17]; CPS > 20:73% [19/26])
- Median progression-free survival was 9 months (
95% CI: 5.2-12.9) - Median duration of response and median overall survival (OS) were not reached
79% overall survival rate at 12-months (30/43 censored)
- Confirmed overall response rate:
- At the time of data cutoff, 14 patients, each of whom are responders, remained on treatment
- In 45 patients the combination was generally well tolerated and no significant overlapping toxicities with pembrolizumab were observed
- Treatment-emergent adverse events (TEAEs) were reported in 45 pts
- G≥3 TEAEs occurred in 27 (
60% ) patients, including 20 (44% ) patients who experienced treatment-related TEAEs - Infusion-related reactions (composite term) were reported in
38% of patients (all Gs) and7% (G3), no G4 or 5, mainly occurred during the first infusion and were resolved
Abstract #: 6024
Poster Board: 432
Session Title: Head and Neck Cancer
Session Date and Time: June 2, 2025, 9:00-12:00 CT
As full presentations become available at the 2025 ASCO® Annual Meeting, they will contemporaneously be available on the Merus website.
An analysis of the confirmed responses observed from administration of petosemtamab across the first line combination (as of the February 27, 2025 data cutoff date) and second-line plus monotherapy phase 2 cohorts (as of the July 5, 2024 data cutoff date), demonstrated that two-thirds of these responses with petosemtamab in HPV-associated p16+ oropharyngeal cancer occurred in never-smokers.
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 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, LinkedIn and Bluesky.
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 presentation; our belief that in this interim dataset, petosemtamab in combination with pembrolizumab are significantly better than the standard of care by essentially every metric; our belief that these data underscore the incredible opportunity petosemtamab holds to become a new standard of care in head and neck cancer; our statements regarding our future execution, including the rapidity of site initiation. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the Securities and Exchange Commission, or SEC, on May 7, 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®, Triclonics®, and ADClonics® 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
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