Merus Announces First Patient Dosed in LiGeR-HN1, a Phase 3 Trial Evaluating Petosemtamab in Combination with Pembrolizumab in 1L r/m HNSCC
Merus N.V. (Nasdaq: MRUS) has announced the dosing of the first patient in its phase 3 trial called LiGeR-HN1. This trial evaluates the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab alone as first-line therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).
The company has received confirmation from 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. Merus' CEO, Bill Lundberg, expressed confidence in petosemtamab's potential to become a new standard of care across r/m HNSCC and possibly beyond, based on strong phase 2 clinical data.
Merus N.V. (Nasdaq: MRUS) ha annunciato la somministrazione della prima dose al paziente nel suo studio di fase 3 chiamato LiGeR-HN1. Questo studio valuta l'efficacia e la sicurezza di petosemtamab, una Biclonics® che mira a EGFR e LGR5, in combinazione con pembrolizumab, rispetto alla somministrazione di pembrolizumab da solo come terapia di prima linea per pazienti con carcinoma a cellule squamose della testa e del collo ricorrente/metastatico (r/m HNSCC) PD-L1 positivo.
La compagnia ha ricevuto conferma dalla Food and Drug Administration (FDA) degli Stati Uniti che petosemtamab 1500 mg ogni due settimane è appropriato per ulteriore sviluppo nell'HNSCC sia come monoterapia che in combinazione con pembrolizumab. Il CEO di Merus, Bill Lundberg, ha espresso fiducia nel potenziale di petosemtamab di diventare un nuovo standard di cura per r/m HNSCC e possibilmente oltre, basandosi su forti dati clinici di fase 2.
Merus N.V. (Nasdaq: MRUS) ha anunciado la dosificación del primer paciente en su ensayo de fase 3 denominado LiGeR-HN1. Este ensayo evalúa la eficacia y seguridad de petosemtamab, un Biclonics® que se dirige a EGFR y LGR5, en combinación con pembrolizumab, en comparación con pembrolizumab solo como terapia de primera línea para pacientes con carcinoma de células escamosas de cabeza y cuello recurrente/metastásico (r/m HNSCC) positivo para PD-L1.
La compañía ha recibido la confirmación de la Administración de Alimentos y Medicamentos de EE. UU. (FDA) de que 1500 mg de petosemtamab cada dos semanas es apropiado para el desarrollo adicional en HNSCC como monoterapia y en combinación con pembrolizumab. El CEO de Merus, Bill Lundberg, expresó confianza en el potencial de petosemtamab para convertirse en un nuevo estándar de atención para r/m HNSCC y posiblemente más allá, basándose en los sólidos datos clínicos de fase 2.
Merus N.V. (Nasdaq: MRUS)는 LiGeR-HN1이라는 3상 시험에서 첫 번째 환자에게 투여를 시작했다고 발표했습니다. 이 시험은 EGFR 및 LGR5를 표적하는 Biclonics®인 petosemtamab와 pembrolizumab의 조합의 효능과 안전성을 평가하며, PD-L1+ 재발/전이성 두경부 편평세포암(r/m HNSCC) 환자를 대상으로 pembrolizumab 단독 요법과 비교합니다.
회사는 미국 식품의약국(FDA)로부터 petosemtamab 1500 mg을 2주마다 투여하는 것이 HNSCC에 대한 단독 요법 및 pembrolizumab과의 조합 요법으로 추가 개발에 적합하다는 확인을 받았습니다. Merus의 CEO인 Bill Lundberg는 petosemtamab이 r/m HNSCC 전반에 걸쳐 새로운 치료 표준이 될 잠재력이 있다는 데 자신감을 표명했으며, 이는 강력한 2상 임상 데이터에 기반하고 있습니다.
Merus N.V. (Nasdaq: MRUS) a annoncé l'administration de la première dose au patient dans son essai de phase 3 appelé LiGeR-HN1. Cet essai évalue l'efficacité et la sécurité de petosemtamab, un Biclonics® ciblant EGFR et LGR5, en combinaison avec pembrolizumab, par rapport à pembrolizumab seul en tant que thérapie de première ligne pour les patients atteints de carcinome épidermoïde récurrent/métastatique de la tête et du cou (r/m HNSCC) positif pour PD-L1.
L'entreprise a reçu la confirmation de la Food and Drug Administration (FDA) des États-Unis que 1500 mg de petosemtamab toutes les deux semaines est approprié pour un développement supplémentaire dans le HNSCC en tant que monothérapie et en combinaison avec pembrolizumab. Le CEO de Merus, Bill Lundberg, a exprimé sa confiance dans le potentiel de petosemtamab pour devenir une nouvelle norme de soins pour r/m HNSCC et éventuellement au-delà, sur la base de fortes données cliniques de phase 2.
Merus N.V. (Nasdaq: MRUS) hat die Dosisvergabe an den ersten Patienten in seiner Phase 3 Studie namens LiGeR-HN1 bekannt gegeben. Diese Studie untersucht die Wirksamkeit und Sicherheit von petosemtamab, einem Biclonics®-Medikament, das auf EGFR und LGR5 abzielt, in Kombination mit Pembrolizumab, verglichen mit Pembrolizumab allein als Erstlinientherapie für Patienten mit PD-L1+ rezidivierenden/metastatischen Plattenepithelkarzinomen des Kopfes und Halses (r/m HNSCC).
Das Unternehmen hat von der U.S. Food and Drug Administration (FDA) die Bestätigung erhalten, dass 1500 mg petosemtamab alle zwei Wochen für die Weiterentwicklung bei HNSCC sowohl als Monotherapie als auch in Kombination mit Pembrolizumab geeignet ist. Der CEO von Merus, Bill Lundberg, äußerte sein Vertrauen in das Potenzial von petosemtamab, ein neuer Standard in der Behandlung von r/m HNSCC und möglicherweise darüber hinaus zu werden, basierend auf starken klinischen Daten der Phase 2.
- First patient dosed in phase 3 trial (LiGeR-HN1) for petosemtamab in combination with pembrolizumab
- FDA confirmation of appropriate dosage for further development
- Strong phase 2 clinical data reported for petosemtamab in HNSCC
- Potential for petosemtamab to become a new standard of care in r/m HNSCC
- None.
Insights
The initiation of the LiGeR-HN1 phase 3 trial for petosemtamab in combination with pembrolizumab is a significant milestone for Merus. This study targets first-line treatment of PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), a challenging cancer with treatment options.
Key points to consider:
- The FDA's confirmation of the 1500 mg every two weeks dosing regimen for petosemtamab validates the company's development strategy.
- Previous phase 2 data showing efficacy both as monotherapy and in combination with pembrolizumab suggests strong potential for this Biclonics® antibody.
- The rapid progression to phase 3 trials in both 1L and 2/3L HNSCC indicates confidence in the drug's potential and efficient execution by Merus.
If successful, petosemtamab could become a new standard of care in r/m HNSCC, potentially expanding Merus's market presence and revenue streams. However, investors should be aware that phase 3 trials are lengthy and costly, with no guarantee of success. The outcome will be important for Merus's long-term prospects in the competitive oncology space.
This news represents a significant advancement in Merus's clinical pipeline, potentially accelerating their path to market. Key considerations for investors include:
- Market opportunity: Head and neck cancer is a substantial market, with over 650,000 new cases worldwide annually. A successful treatment could capture a significant portion of this market.
- Competitive landscape: While pembrolizumab is already approved for HNSCC, the combination with petosemtamab could offer improved efficacy, potentially disrupting the current treatment paradigm.
- Financial implications: Phase 3 trials are expensive, likely increasing Merus's burn rate. However, with a market cap of
$3.26 billion , the company appears well-positioned to fund this pivotal study. - Partnership potential: Success in this trial could attract potential partners or acquirers, particularly given the novel Biclonics® platform.
Investors should monitor trial progress closely, as positive interim results could significantly impact Merus's valuation. However, it's important to remember that final results are likely years away and the biotech sector is inherently risky.
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Sept. 30, 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, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 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.
“Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC.”
More details of the trial can be found at clinicaltrials.gov.
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 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 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, 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 design and execution of the LiGeR-HN1 trial, 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; our belief that petosemtamab has the potential to become a new standard of care across r/m HNSCC; and our belief in alignment with the FDA on dose; 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.
FAQ
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