On May 26, 2022 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), reported the publication of the abstract highlighting updated interim data from the ongoing phase 1/2 eNRGY trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with NRG1 fusion (NRG1+) cancer, on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website (Press release, Merus, MAY 26, 2022, View Source [SID1234615191]). The abstract includes data as of a January 12, 2022 data cutoff date. As of that time, 99 patients with NRG1+ cancer had been treated and efficacy was assessed in 73 patients with the opportunity to have ≥ 6 month follow-up, and that met the criteria for the primary efficacy population. The oral presentation will include updated interim data and will be presented by the Principal Investigator of the eNRGy trial, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC), at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5, 2022, 9:45-11:15 a.m. CT.
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"We are excited to provide a more mature, interim clinical dataset from the Zeno program and are thrilled that Zeno continues to demonstrate activity across different tumor types," said Dr. Andrew Joe, Chief Medical Officer at Merus. "We continue to be encouraged by the potential of Zeno to help patients with NRG1+ cancer."
The reported data 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.
Key findings of the abstract include:
As of January 12, 2022, 99 patients were treated with Zeno. 73 pts who were treated as of July 12, 2021 were evaluable for response and had the opportunity for ≥ 6 months follow-up and met the criteria for the primary efficacy population
The investigator-assessed overall responses rate (ORR) by RECIST 1.1. criteria was 34% (90%CI, 25;44)
The median duration of response (DOR) was 9.1 months (95% CI, 5.2-12.0) and Kaplan-Meier estimate of DOR rate at 6 month was 70%.
Responses were observed in patients with multiple types of NRG1+ cancer
Zeno continues to be well-tolerated
Oral Presentation Details:
Title: Efficacy and safety of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) cancers
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 105
Session Title: Clinical Science Symposium/ Bispecifics: Are Two Better Than One?
Session Date and Time: June 5, 2022, 9:45-11:15 a.m. CT
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Sunday, June 5, 2022 at 6:00 p.m. CT to discuss the Zeno clinical data and provide a program update. 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: Sunday, June 5, 6:00 p.m. CT
Webcast link: available on our website
Dial-in: Toll-free: 18772601463/ International: 17066435907
Conference ID: 7194538
About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.
About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 gene fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.