Petosemtamab

Petosemtamab in combination with pembrolizumab in 1L r/m PD-L1 expressing HNSCC ongoing with clinical data update planned for 2025 Petosemtamab in mCRC evaluation expanded to include 1L and 3L+; initial clinical data planned for 2025 – Conference Call on Saturday, December 7th at 9:00 a.m. ET Dec. 07, 2024 -- 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 interim clinical data as of a July 5, 2024 data cutoff from the ongoing phase 1/2 trial of petosemtamab, a Biclonics® targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC). These data were presented by Christophe Le Tourneau MD, Ph.D., Institut Curie, Paris, France at the European Society for Medical Oncology (ESMO®) Asia Congress on Saturday, Dec. 7 in Singapore. “Petosemtamab clinical data in r/m HNSCC continues to demonstrate potentially practice changing efficacy and safety, both as monotherapy in 2L+ and in combination with pembrolizumab in 1L PD-L1 expressing HNSCC," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. “Further, the monotherapy durability of petosemtamab thus far compares favorably to current standard of care, which we believe is another positive indicator for the likelihood of success of our phase 3 investigation of petosemtamab and pembrolizumab in 1L PD-L1 expressing HNSCC.” “Head and neck squamous cell carcinoma remains a deadly disease with limited treatment options,” added Dr. Le Tourneau. “With its strong clinical outcomes across a large dataset of patients, regardless of HPV status and EGFR expression, petosemtamab has the potential to become a new standard of care for patients with recurrent/metastatic head and neck cancer.” 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 presentation include: As of a July 5, 2024 data cutoff date, 82 pts were treated with petosemtamab 1500 mg Q2W The efficacy population consists of 75 pts who had the opportunity for 4 or more months follow up and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death Seven pts were not efficacy evaluable: 6 pts were previously described at AACR 2023 and one additional patient withdrew due to infusion related reaction (IRRs) on Day 1 Confirmed overall response rate (ORR): 36% (90% CI: 27–46; 27/75) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including 4 complete responses (CRs), with one CR continuing on treatment for more than 3 years as of the data cutoff; and 13% (2/15) ORR in HPV associated cancer with another 5 patients achieving stable disease At the time of data cutoff, 10 pts remain on treatment including 8 responders and 2 pts with stable disease Median duration of response (DOR), progression free survival (PFS) and overall survival (OS) were 6.2, 4.9 and 11.4 months For the most mature data set, the single arm cohort previously presented at AACR 2023, as of a July 5, 2024 data cutoff, for all 54 patients, the median DOR, PFS and OS were 6.7, 5.1, and 12.0 months, respectively; among the 48 treatment evaluable subset, they were 6.7, 5.2, and 12.5 months, respectively Petosemtamab 1500 mg Q2W continues to be well tolerated with a manageable safety profile with no new safety signals observed (82 pts) Infusion related reactions (IRRs) were predominantly seen on day 1 of cycle 1; a clinically meaningful reduction in the incidence and severity of IRR was observed with an updated administration regimen As of a July 5, 2024 data cutoff date, 28 pts were treated with petosemtamab 1100 mg Q2W The efficacy population consists of 27 pts who had the opportunity for 4 or more months follow up and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death One pt was not evaluable for efficacy due to withdrawing consent with ORR: 19% (90% CI: 8–35; 5/27), including 2 CRs, by RECIST v1.1. per investigator assessment r/m HNSCC: LiGeR-HN1 phase 3 trial in 1L and LiGeR-HN2 phase 3 trial in 2/3L enrolling; phase 2 trial of petosemtamab in combination with pembrolizumab in PD-L1+ 1L HNSCC ongoing with a clinical data update planned for 2025 mCRC: Phase 2 trial of petosemtamab in combination with standard chemotherapy in 2L metastatic colorectal cancer (mCRC) enrolling; phase 2 trial in 1L mCRC in combination with standard chemotherapy planned to initiate in 2025, and phase 2 trial in 3L+ monotherapy planned to initiate in 2025; mCRC initial clinical data planned for 2025 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 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) 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. 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. The content above comes from the network. if any infringement, please contact us to modify.

The Dutch biotech Merus received the first-ever FDA accelerated approval for a systemic treatment targeting a specific genetic fusion in patients with either non-small cell lung cancer or pancreatic cancer. The approval, disclosed Wednesday evening , is Merus’ first, and the drug will be sold as Bizengri. It’s a bispecific antibody targeting HER2 and HER3, and is approved for patients with advanced, unresectable, or metastatic non-small cell lung cancer or pancreatic adenocarcinoma who have an NRG1 gene fusion. Bizengri, also known as zenocutuzumab, was tested in an open label trial among 64 patients with NSCLC and 30 with pancreatic cancer. The overall response rate in the lung cancer cohort was 33%, and 40% in the pancreatic cancer group. The label includes a black box warning for pregnant women. Merus won’t actually spearhead commercialization of the drug in the US, after selling off rights earlier this week to Partner Therapeutics in exchange for an undisclosed upfront fee and $130 million in potential milestone payments. Merus’ development efforts have centered on another late-stage bispecific, petosemtamab, with new data giving the company optimism that it could be the standard-of-care in second-line head and neck cancer. Phase 2 results for petosemtamab released Sunday found that among 12 evaluable patients receiving the 1,500 mg dose of petosemtamab, one had a complete response, three had a partial response and another had an unconfirmed partial response. The data came from a dose comparison cohort that has so far randomized 42 patients to receive the 1,500 mg dose or the 1,100 mg dose.