– 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
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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
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7.2 months median duration of response
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5.1 months median progression free survival
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12.5 months median overall survival
As of a March 6, 2024 data cutoff date, 42 pts were randomized to the 1500 mg vs. 1100 mg dose comparison cohort
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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)
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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
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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 30% to more than 1 million new cases annually by 2030.² HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.
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.