Merus Announces Publication of an Abstract on Petosemtamab as 2L+ treatment of r/m HNSCC at the ESMO Asia Congress 2024
Merus (MRUS) announced updated clinical data for petosemtamab in treating recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). As of November 2023, among 54 patients treated with 1500mg Q2W, 47 were evaluable showing a 40.4% response rate with 7.2 months median duration of response and 12.5 months median overall survival. In a dose comparison study as of March 2024, the 1500mg dose showed stronger efficacy with 5 responses (including 1 complete response) in 12 evaluable patients, compared to 1 confirmed response in 10 patients at 1100mg. The treatment was well-tolerated at both doses with no grade 5 adverse events reported.
Merus (MRUS) ha annunciato dati clinici aggiornati per il petosemtamab nel trattamento del carcinoma a cellule squamose della testa e del collo ricorrente/metastatico (r/m HNSCC). A novembre 2023, tra 54 pazienti trattati con 1500mg ogni due settimane, 47 erano valutabili, mostrando un tasso di risposta del 40,4% con una durata mediana della risposta di 7,2 mesi e una sopravvivenza mediana globale di 12,5 mesi. In uno studio di comparazione delle dosi, a marzo 2024, la dose da 1500mg ha mostrato un'efficacia maggiore con 5 risposte (inclusa 1 risposta completa) in 12 pazienti valutabili, rispetto a 1 risposta confermata in 10 pazienti con 1100mg. Il trattamento è stato ben tollerato a entrambe le dosi senza eventi avversi di grado 5 riportati.
Merus (MRUS) anunció datos clínicos actualizados para el petosemtamab en el tratamiento del carcinoma de células escamosas de cabeza y cuello recurrente/metastásico (r/m HNSCC). Hasta noviembre de 2023, entre 54 pacientes tratados con 1500mg cada 2 semanas, 47 fueron evaluables, mostrando una tasa de respuesta del 40,4% con una duración mediana de respuesta de 7,2 meses y una supervivencia global mediana de 12,5 meses. En un estudio de comparación de dosis a marzo de 2024, la dosis de 1500mg mostró una eficacia más fuerte con 5 respuestas (incluyendo 1 respuesta completa) en 12 pacientes evaluables, en comparación con 1 respuesta confirmada en 10 pacientes a 1100mg. El tratamiento fue bien tolerado en ambas dosis sin eventos adversos de grado 5 reportados.
Merus (MRUS)는 재발성/전이성 두경부 편평세포암(r/m HNSCC) 치료를 위한 페토세멘타맙의 업데이트된 임상 데이터를 발표했습니다. 2023년 11월 현재, 1500mg(2주에 한 번)으로 치료받은 54명의 환자 중 47명이 평가 가능했으며, 응답률은 40.4%로 나타났고, 응답의 중앙 지속 기간은 7.2개월, 전체 생존 기간의 중앙값은 12.5개월이었습니다. 2024년 3월 기준의 용량 비교 연구에서 1500mg의 용량은 12명의 평가 가능한 환자 중 5명에서 반응(1명의 완전 반응 포함)을 나타내어 1100mg에서 10명의 환자 중 1명의 확인된 반응과 비교하여 더 강력한 효능을 보였습니다. 두 용량 모두에서 치료는 잘 견뎌졌으며, 5등급의 부작용은 보고되지 않았습니다.
Merus (MRUS) a annoncé des données cliniques mises à jour pour le petosemtamab dans le traitement du carcinome à cellules squameuses de la tête et du cou récurrent/métastatique (r/m HNSCC). En novembre 2023, parmi 54 patients traités avec 1500mg toutes les deux semaines, 47 étaient évaluables, montrant un taux de réponse de 40,4% avec une durée médiane de réponse de 7,2 mois et une survie globale médiane de 12,5 mois. Dans une étude de comparaison de doses en mars 2024, la dose de 1500mg a montré une efficacité plus forte avec 5 réponses (dont 1 réponse complète) chez 12 patients évaluables, comparé à 1 réponse confirmée chez 10 patients à 1100mg. Le traitement a été bien toléré aux deux doses sans événements indésirables de grade 5 rapportés.
Merus (MRUS) gab aktualisierte klinische Daten zu Petosemtamab bei der Behandlung von wiederkehrendem/metastasiertem Plattenepithelkarzinom der Kopf- und Halsregion (r/m HNSCC) bekannt. Stand November 2023 waren von 54 Patienten, die mit 1500mg alle zwei Wochen behandelt wurden, 47 evaluierbar, was eine Antwortquote von 40,4% zeigte, mit einer medianen Ansprechdauer von 7,2 Monaten und einer medianen Gesamtüberlebenszeit von 12,5 Monaten. In einer Dosierungsvergleichsstudie im März 2024 zeigte die Dosis von 1500mg eine stärkere Wirksamkeit mit 5 Antworten (darunter 1 vollständige Antwort) bei 12 evaluierbaren Patienten im Vergleich zu 1 bestätigten Antwort bei 10 Patienten mit 1100mg. Die Behandlung wurde bei beiden Dosen gut vertragen, ohne dass schwere unerwünschte Ereignisse vom Grad 5 berichtet wurden.
- Strong 40.4% response rate in evaluable patients at 1500mg dose
- Promising survival metrics with 12.5 months median overall survival
- Better efficacy demonstrated at 1500mg vs 1100mg dose
- Well-tolerated safety profile with no grade 5 adverse events
- Some patients (5) withdrew due to infusion-related reactions on Day 1
Insights
The interim Phase 2 data for petosemtamab shows promising results in treating head and neck cancer. The 40.4% overall response rate in previously treated patients is clinically significant, with
The dose comparison study between 1500mg and 1100mg demonstrates superior efficacy at the higher dose, with 5 responses out of 12 evaluable patients at 1500mg versus only 1 response out of 10 patients at 1100mg. The drug's tolerability profile remains favorable, with no grade 5 adverse events reported, supporting its potential as a second-line treatment option.
This data strengthens petosemtamab's position as a promising therapy in the
– Petosemtamab 1500 mg monotherapy phase 2 interim data continues to demonstrate clinically meaningful activity in 2L+ HNSCC
– Conference call on Saturday, Dec. 7 at 9:00 a.m. ET to discuss full data set
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 01, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced the publication of an abstract regarding petosemtamab, a Biclonics® targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) on the European Society for Medical Oncology (ESMO®) Asia Congress website. The abstract presents updated clinical data on petosemtamab from the initial expansion cohort (1500 mg) and a new dose-comparison cohort (1100 mg vs. 1500 mg) in 2L+ HNSCC for presentation at the ESMO® Asia Congress 2024 taking place in Singapore, Dec. 6-8, 2024.
The presentation will be discussed on a conference call on Saturday, December 7, at 9:00 a.m. ET. The presentation will include interim data from a later data cutoff date with additional patients evaluable for response and more mature duration of treatment information.
“Petosemtamab 1500 mg monotherapy continues to demonstrate consistent, durable, and clinically meaningful efficacy in 2L+ r/m HNSCC, underscoring its potential to become a new standard of care,” said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. “We are looking forward to our upcoming presentation which will include new information with updated efficacy and safety of the larger, combined 2L+ dataset.”
Presentation title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Observations in the abstract include:
- As of a November 6, 2023 data cutoff date 54 pts were treated with 1500 mg Q2W in the expansion cohort reported initially at AACR® 2023
- 47* pts were evaluable for response (≥4 months follow up prior to data cutoff date and ≥1 post baseline scan, or early progressive disease (PD)) and overall response rate was
40.4% (19/47 and 1 unconfirmed partial response (PR) that confirmed post cutoff, 20/47) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment - 7.2 months median duration of response
- 5.1 months median progression free survival
- 12.5 months median overall survival
- 47* pts were evaluable for response (≥4 months follow up prior to data cutoff date and ≥1 post baseline scan, or early progressive disease (PD)) and overall response rate was
- As of a March 6, 2024 data cutoff date, 42 pts were randomized to the 1500 mg vs. 1100 mg dose comparison cohort
- At 1500 mg, 12 pts were evaluable for response, 5 responses were observed including 1 complete response, 3 PRs, and 1 unconfirmed PR (confirmed post cutoff)
- At 1100 mg, 10 pts were evaluable for response with 1 confirmed PR observed
- Petosemtamab was well tolerated at both dose levels; no new safety signals observed
- No grade 5 treatment emergent adverse events were reported
*6 pts were excluded per protocol (as previously presented at AACR® 2023): 5 pts withdrew due to infusion related reactions on Day 1; 1 pt had exclusion criteria deviation; 1 pt had <4 months follow up at the data cutoff
Title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Abstract #: 411MO
Session Title: Mini Oral session: Head and Neck cancers
Session Date and Time: December 7, 2024; 14:30 - 16:10 p.m. SGT
Location Hall: 404
As the full presentation becomes available at the ESMO® Asia Congress 2024, it will contemporaneously be available on the Merus website.
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on December 7, 2024 at 9:00 a.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: Dec. 07, 2024 at 9:00 a.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871/ International: 1 (646) 307-1963
Conference ID: 1978503
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, 92 (2020)
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 Merus N.V.
Merus is a clinical-stage 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; and our belief that petosemtamab has the potential to become a new standard of care. These forward-looking statements are based on management’s current expectations. 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 period ended September 30, 2024, filed with the Securities and Exchange Commission, or SEC, on October 31, 2024, 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.
FAQ
What was the response rate for petosemtamab in HNSCC patients in Merus's (MRUS) Phase 2 trial?
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