MRUS - Merus Announces Business Update Conference Call | Benzinga

• Zeno interim clinical data continues to show robust efficacy in NRG1+ NSCLC and PDAC: Sufficient clinical data expected in 1H24 to support potential BLA submissions

• Petosemtamab 2L+ HNSCC phase 3 trial design supported by INTERLINK-1 control arm
• Clinical data update on petosemtamab monotherapy in 2L+ HNSCC planned 2024
• MCLA-129 abstracts accepted at ESMO Asia
• Investor call on Monday, October 16 at 7:30 a.m. ET

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Oct. 15, 2023 (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 it will host a conference call to discuss a business update on Monday, October 16, 2023 at 7:30 a.m. ET.

Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics^®): NRG1 fusion (NRG1+) cancer and other solid tumors

Today two abstracts were published on the European Society for Medical Oncology Congress (ESMO) 2023 website. The abstracts highlight updated interim clinical data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer. The Principal Investigator of the eNRGy trial, Dr. Alison Schram of Memorial Sloan-Kettering Cancer Center will present a mini oral session on NRG1+ NSCLC. The ESMO Congress 2023 will take place in Madrid, Spain October 20-24, 2023. 

"Zeno continues to show remarkably consistent efficacy over time, with robust and durable responses in these difficult-to-treat indications," said Dr. Andrew Joe, Chief Medical Officer at Merus. "We recently met with the FDA in the context of our two breakthrough therapy designations and based on these productive and collaborative discussions, we believe we will have sufficient data for both NRG1+ NSCLC and NRG1+ PDAC in the first half of 2024 to support biologics license application submissions." 

Interim data included in the abstracts are from the phase 1/2 eNRGy trial and EAP which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. Updated data will be provided in the presentations to include additional patients as well as follow-up on safety and efficacy for the patients presented in the abstracts: 

Mini Oral Presentation Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC) 

• Observations in the abstract include:
  
  • As of a February 1, 2023 data cutoff date, 85 patients (pts) with NRG1+ NSCLC were enrolled. 64 pts with measurable disease were treated as of August 1, 2022 allowing for the potential for ? 6 months follow up and were evaluable for response  
    
    • 34% overall response rate (ORR) (95% CI, 23-47) by RECIST v1.1. per investigator assessment 
    • 78% of pts had target lesion reduction  
    • 12.9 months median duration of response (DOR), with responses ongoing in 50% of pts 
    • Among the 85 pts enrolled, Grade ? 3 adverse events (AEs) irrespective of causality occurred in < 4% pts 

Presentation Details:
Session Category: Mini oral session 1 
Session: NSCLC, metastatic 
Date: Saturday, October 21, 2023  
Time: 9:35-9:40 CEST 
Presentation #: 1315MO 

Poster Presentation Title: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC) 

• Observations in the abstract include:
  
  • As of a February 1, 2023 data cutoff date, 38 pts with NRG1+ PDAC were enrolled. 27 pts with measurable disease were treated as of August 1, 2022 allowing for the potential for ? 6 months follow-up and were evaluable for response  
    
    • 44% ORR (95% CI, 26-65) by RECIST v1.1. per investigator ...

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