Merus Announces First Patient Dosed in LiGeR-HN2, a Phase 3 Trial Evaluating Petosemtamab in 2/3L r/m HNSCC
Merus N.V. (Nasdaq: MRUS) has announced the dosing of the first patient in its phase 3 trial (LiGeR-HN2) evaluating petosemtamab in previously treated recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). The trial will compare petosemtamab to investigator's choice of single agent chemotherapy or cetuximab. The FDA has confirmed that the 1500 mg every two weeks dosage is appropriate for further development in HNSCC as monotherapy and in combination with pembrolizumab. This dosage will be used in both the 2/3L phase 3 trial (LiGeR-HN2) and the 1L trial (LiGeR-HN1) in r/m HNSCC. Merus believes petosemtamab has the potential to become the new standard of care across r/m HNSCC.
Merus N.V. (Nasdaq: MRUS) ha annunciato la somministrazione del primo paziente nel suo trial di fase 3 (LiGeR-HN2) che valuta petosemtamab in pazienti precedentemente trattati per carcinoma squamoso della testa e del collo ricorrente/metastatico (r/m HNSCC). Lo studio confronterà petosemtamab con la scelta dell'investigatore di chemioterapia con un singolo agente o cetuximab. La FDA ha confermato che il dosaggio di 1500 mg ogni due settimane è appropriato per ulteriore sviluppo in HNSCC sia come monoterapia che in combinazione con pembrolizumab. Questo dosaggio sarà utilizzato sia nel trial di fase 3 2/3L (LiGeR-HN2) che nel trial di fase 1 (LiGeR-HN1) in r/m HNSCC. Merus crede che petosemtamab abbia il potenziale per diventare il nuovo standard di cura per il r/m HNSCC.
Merus N.V. (Nasdaq: MRUS) ha anunciado la dosificación del primer paciente en su ensayo de fase 3 (LiGeR-HN2) que evalúa petosemtamab en carcinoma de células escamosas de cabeza y cuello recurrente/metastásico (r/m HNSCC) previamente tratado. El ensayo comparará petosemtamab con la elección del investigador entre quimioterapia de un solo agente o cetuximab. La FDA ha confirmado que la dosis de 1500 mg cada dos semanas es apropiada para un desarrollo posterior en HNSCC como monoterapia y en combinación con pembrolizumab. Esta dosis se utilizará tanto en el ensayo de fase 3 2/3L (LiGeR-HN2) como en el ensayo de fase 1 (LiGeR-HN1) en r/m HNSCC. Merus cree que petosemtamab tiene el potencial de convertirse en el nuevo estándar de atención en el r/m HNSCC.
Merus N.V. (Nasdaq: MRUS)가 사전에 치료받은 재발/전이성 두경부 편평세포 암종(r/m HNSCC)에서 petosemtamab를 평가하는 3상 시험 (LiGeR-HN2)에서 첫 번째 환자의 투약을 발표했습니다. 이 시험은 petosemtamab와 연구자가 선택한 단일 화학요법제 또는 cetuximab과 비교할 것입니다. FDA는 1500 mg을 2주마다 투여하는 용량이 HNSCC에서 단독 요법 및 pembrolizumab과의 병용 요법으로 추가 개발에 적합하다고 확인했습니다. 이 용량은 재발/전이성 두경부 편평세포 암종(r/m HNSCC)에서 2/3L 3상 시험(LiGeR-HN2)과 1상 시험(LiGeR-HN1) 모두에 사용될 것입니다. Merus는 petosemtamab이 r/m HNSCC에서 새로운 치료 표준이 될 잠재력이 있다고 믿고 있습니다.
Merus N.V. (Nasdaq: MRUS) a annoncé le dosage du premier patient dans son essai de phase 3 (LiGeR-HN2) évaluant petosemtamab chez des patients précédemment traités pour un carcinome épidermoïde récidivant / métastatique de la tête et du cou (r/m HNSCC). L’essai comparera le petosemtamab au choix de l’investigateur entre une chimiothérapie à agent unique ou le cetuximab. La FDA a confirmé que la dose de 1500 mg tous les deux semaines est appropriée pour un développement ultérieur dans le HNSCC en tant que monothérapie et en combinaison avec le pembrolizumab. Cette dose sera utilisée dans l’essai de phase 3 2/3L (LiGeR-HN2) ainsi que dans l’essai de phase 1 (LiGeR-HN1) pour les r/m HNSCC. Merus est convaincu que le petosemtamab a le potentiel de devenir le nouveau standard de soins dans le r/m HNSCC.
Merus N.V. (Nasdaq: MRUS) hat die Dosierung des ersten Patienten in seiner Phase-3-Studie (LiGeR-HN2) angekündigt, die petosemtamab bei zuvor behandelten Patienten mit rezidivierenden/metastatischen Plattenepithelkarzinomen im Kopf-Hals-Bereich (r/m HNSCC) bewertet. Die Studie wird petosemtamab mit der Wahl des Prüfarztes zwischen einer Einzeltherapie mit Chemotherapeutika oder Cetuximab vergleichen. Die FDA hat bestätigt, dass die Dosierung von 1500 mg alle zwei Wochen für die weitere Entwicklung in HNSCC sowohl als Monotherapie als auch in Kombination mit Pembrolizumab geeignet ist. Diese Dosierung wird sowohl in der 2/3L Phase-3-Studie (LiGeR-HN2) als auch in der 1L-Studie (LiGeR-HN1) für r/m HNSCC verwendet. Merus glaubt, dass petosemtamab das Potenzial hat, der neue Standard der Versorgung im Bereich r/m HNSCC zu werden.
- First patient dosed in phase 3 trial for petosemtamab in r/m HNSCC
- FDA confirmed 1500 mg Q2W dosage for petosemtamab in HNSCC
- Potential for petosemtamab to become new standard of care in r/m HNSCC
- None.
The initiation of the LiGeR-HN2 Phase 3 trial for petosemtamab represents a significant milestone in the treatment landscape for recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). Petosemtamab, targeting EGFR and LGR5, focuses on pathways known to drive cancer proliferation and resistance. The confirmation of the dosing regimen from the FDA further underscores the potential of this therapy. If the trial yields positive results, petosemtamab could offer a new treatment avenue beyond current standards like chemotherapy and cetuximab, potentially improving survival rates and quality of life for these patients.
Merus's initiation of this Phase 3 trial for petosemtamab can be seen as a positive indicator for the company's future financial health. The FDA's feedback on the appropriate dosing regimen helps de-risk the development pathway, improving investor confidence. Successful outcomes from this trial could lead to commercial approval, opening up a substantial market opportunity in the multi-billion-dollar oncology space, specifically for r/m HNSCC treatment. Moreover, this advancement aligns with Merus's strategic goal to establish itself as a leader in the multispecific antibody domain, potentially driving up the company's valuation and stock price.
The announcement that Merus has dosed the first patient in the LiGeR-HN2 trial is encouraging for the market. The firm’s innovative approach, utilizing Biclonics® technology that targets multiple cancer pathways, sets it apart in the crowded oncology space. By confirming a viable dosing schedule through FDA feedback, Merus has positioned itself advantageously for potential market entry upon successful trial completion. This could catalyze broader acceptance and integration of multispecific antibody therapies, indicating a shift towards more targeted and effective treatments in oncology.
Petosemtamab 1500 mg Q2W confirmed for both 2/3L phase 3 trial (LiGeR-HN2) and 1L trial (LiGeR-HN1) in r/m HNSCC following FDA feedback
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 24, 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 that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, compared to investigator’s choice of single agent chemotherapy or cetuximab in previously treated (2/3L) patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) referred to as the LiGeR-HN2 trial.
Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.
“With petosemtamab’s strong clinical data in HNSCC and alignment with the FDA on dose, we are excited to have treated our first patient in the 2/3L phase 3 trial,” said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. “We believe petosemtamab has the potential to become the new standard of care across r/m HNSCC.”
More details of the trial can be found at clinicaltrials.gov.
About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab compared to investigator’s choice of methotrexate, docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is open to adult patients that have progressed on or after anti-PD-1 therapy and platinum-containing therapy. 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 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, 92 (2020)
About Merus
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, X 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 evaluation of petosemtamab in patients with HNSCC in monotherapy and in combination with pembrolizumab, our belief, through feedback with the U.S. FDA, that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab; and our belief in alignment with the FDA on dose, our excitement to having treated our first patient in the 2/3L phase 3 trial; and belief that petosemtamab has the potential to become a new standard of care treatment for r/m HNSCC; and that the incidence of HNSCC continues to rise and is anticipated to increase by
Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.
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FAQ
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