On October 23, 2023 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 interim clinical data, as of a July 31, 2023 data cutoff date, from the phase 1/2 eNRGy trial and Early Access Program (EAP) of the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) cancer presented by Principal Investigator, Dr. Alison Schram* of Memorial Sloan Kettering Cancer Center at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 (Press release, Merus, OCT 23, 2023, View Source [SID1234636269]).
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"I’ve been impressed by the consistency of the Zeno clinical data and am convinced Zeno has the potential to be both a first and best in class treatment for NRG1+ cancer," said Dr. Andrew Joe, Chief Medical Officer at Merus. "I expect we will have the dataset in the first half of 2024 to support potential BLA submissions in both NRG1+ NSCLC and PDAC."
Dr. Schram added, "Currently, there are no approved therapies specifically for the treatment of NRG1+ cancer, resulting in patients being treated with standard of care by tumor type despite data suggesting NRG1+ cancers may respond poorly to chemoimmunotherapy. With Zeno’s durable efficacy and excellent safety profile reported at ESMO (Free ESMO Whitepaper), I believe Zeno could be an important, new standard of care for 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.
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 presentation include:
As of July 31, 2023 data cutoff date, 105 patients with NRG1+ NSCLC were treated with Zeno. 78 patients with measurable disease were treated by February 13, 2023, allowing for the potential for ≥ 24 week follow-up, and who met the criteria for the primary analysis population.
37.2% (29/78; 95% Cl: 26.5-48.9) overall response rate (ORR) per RECIST v1.1 by investigator assessment
61.5% (95% CI: 49.8 – 72.3) clinical benefit rate
14.9 months median duration of response (DOR) and 20 of patients were continuing treatment as of the data cutoff
Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
Observations in the presentation include:
As of July 31, 2023 data cutoff date, 44 patients with NRG1+ PDAC were treated with Zeno. 33 patients with measurable disease were treated by February 13, 2023, allowing for the potential for ≥ 24 weeks follow-up, and who met the criteria for the primary analysis population.
42.4% (95% CI, 25.5–60.8) ORR per RECIST v1.1 by investigator assessment; 1 (3%) patient achieved a complete response, and 13 (39%) patients achieved a partial response
72.7% (95% CI, 54-87) clinical benefit rate
82% experienced tumor reduction
Of 21 patients evaluable for CA 19-9 levels, 78% showed a ≥ 50% decrease in CA 19-9 values from baseline
9.1 months (95% CI, 5.5–12.0) median DOR; and 6 patients were continuing treatment as of the data cutoff
Safety findings from both presentations: Zeno demonstrated a well-tolerated safety profile among the 189 NRG1+ cancer patients who were treated with 750 mg Q2W monotherapy, with only 6% of patients experiencing related grade 3-4 toxicities.
The full presentations are available on the Publications page of our website.
*Dr. Schram has financial interests related to Merus.
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+ cancer. 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.