On May 19, 2021 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 interim data, as of a January 12, 2021 cutoff, from the phase 1/2 eNRGY trial and Early Access Program (EAP) of bispecific antibody zenocutuzumab (Zeno) in patients with NRG1+ cancers, on the ASCO (Free ASCO Whitepaper) website (Press release, Merus, MAY 19, 2021, View Source [SID1234580372]). An oral presentation containing an updated interim analysis with a data cutoff date of April 13, 2021 will be presented virtually by Lead Author, Dr. Alison Schram of Memorial Sloan Kettering Cancer Center (MSKCC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting on Friday, June 4, 2021 from 11:00 AM -2:00 PM ET.
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Dr. Andrew Joe, Chief Medical Officer at Merus stated, "We continue to be encouraged by the observed clinical activity and safety profile of Zeno in the ongoing eNRGy trial, especially in previously treated patients with pancreatic cancer. The clinical activity and durability data continue to mature, and we look forward to Dr. Schram’s presentation of an updated interim analysis of 45 evaluable patients with multiple tumor types at the ASCO (Free ASCO Whitepaper) Annual Meeting on June 4."
The reported data are from the ongoing phase 1/2 eNRGy trial and EAP, which are investigating the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and NRG1+ other solid tumors.
Key findings in the abstract include:
As of January 12, 2021, 51 patients were treated with Zeno, of whom 33 were evaluable for response. Tumor regression was observed in 25 out of 33 patients, with confirmed partial responses in 9 of 33 (27% ORR), including 4 of 10 patients (40% ORR) with pancreatic cancer.
Zeno continues to be well tolerated with the majority of adverse events of mild or moderate (Grade 1 or 2) severity, regardless of causality.
Presentation Details:
Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Lead Author: Alison Schram, MD, Memorial Sloan Kettering Cancer Center, NY
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT
Presentation Time: 12:00-12:12 PM EDT
Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Sunday, June 6, 2021 at 6:00 pm ET to discuss the Zeno clinical data and provide a program update. A replay will be available after the completion of the call on the Investors and Media section of our website.
Date: Sunday, June 6, 6:00 pm ET
Webcast link: available on our website
Dial-in: Toll-Free: 1-877-260-1463 / International: 1-706-643-5907
Conference ID: 9678617
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+ cancers. 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+). 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+ cancers. In preclinical studies, Zeno also potently inhibits HER2/HER3 heterodimer formation and tumor growth in models harboring NRG1 fusions.