- 51 patients with NRG1+ cancer have been treated, including 33 patients evaluable for response, as of the January 12, 2021, data cutoff date
- Encouraging early clinical activity observed, with confirmed partial responses in 4 of 10 patients with pancreatic cancer (40%) and in 9 of 33 patients across all NRG1+ tumor types (27%)
- Zenocutuzumab observed to be well tolerated with most adverse events being mild or moderate (Grade 1 or 2)
- Oral presentation of an updated interim analysis of 45 evaluable patients to be presented at ASCO on June 4, 11 AM-2 PM ET
- Company to host investor call to discuss clinical results and provide a program update on Sunday, June 6 at 6:00 PM ET
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 19, 2021. 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 Annual Meeting on Friday, June 4, 2021 from 11:00 AM -2:00 PM ET.
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 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 Mediasection 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.govand Merus' trial website at www.nrg1.comor by calling 1-833-NRG-1234.
About Zeno
Zenois 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.
About Merus N.V.
Merusis 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, http://www.merus.nland https://twitter.com/MerusNV.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the clinical development of zenocutuzumab, future clinical trial results, clinical activity and safety profile of Zeno in the on-going eNRGy trial and EAP, including in previously treated pancreatic cancer, and each cohort of the eNRGy trial. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or Biclonics, Triclonics and multispecific antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; and our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 filed with the Securities and Exchange Commission, or SEC, on May 6, 2021, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Biclonics and Triclonics is a registered trademark of Merus N.V.
