Merus Announces the Acceptance of Six Abstracts at Upcoming Medical Conferences and Provides Program Updates - Seite 2

Zenocutuzumab (MCLA-128: HER3 x HER2 Biclonics)

NRG1+ Cancers

Merus provided an update in October 2019 on the eNRGy trial and reported encouraging early clinical activity from the administration of Zeno (monotherapy) in several patients with pancreatic or non-small cell lung cancer (NSCLC) harboring NRG1 gene fusions (NRG1+) including tumor shrinkage, symptomatic improvement and durability up to the then most recent clinical assessments. 

The NRG1 gene fusion is a rare, powerful driver of cancer cell growth found in lung, pancreatic and other solid tumor types. Zeno, through its unique mechanism of binding to HER2 and blocking NRG1 fusion protein interaction with HER3, has the potential to be particularly effective against NRG1+ cancers.

Merus continues to enroll patients on 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. The majority of global clinical trial sites for are now open and enrolling patients. 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.

The Company expects to present updated data from the Phase 1/2 eNRGy trial at a medical conference by the end of 2020.

At the upcoming American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, the following Merus abstracts and poster presentations will be reported:

      -   NRG1 Fusion-Drive Cancers: A Systemic Literature Review and Meta-Analysis. Abstract # e15605
A robust epidemiologic methodology based on a meta-analysis of literature by an independent organization engaged by Merus found the prevalence of NRG1 fusion cancers to be 3.3% in pancreatic ductal adenocarcinoma (95% confidence intervals (CI): 0.3-28.7%) and 9.8% in the invasive mucinous adenocarcinoma subtype of NSCLC  (95% CI: 4.7-19.6%), reaffirming the clinical and commercial potential of Zeno in this patient population.

      -    A phase 2 basket study of MCLA-128, a bispecific antibody targeting the HER3 pathway, in NRG1 fusion-positive advanced solid tumors. Abstract # TPS3654
A Trials in Progress abstract describes the ongoing eNRGy clinical trial for zenocutuzumab in NRG1 fusion cancers.

Metastatic Breast Cancer

Merus has now completed enrollment in two Phase 2 trials of Zeno in metastatic breast cancer. The consistent safety results across both trials strongly supports the excellent safety profile of Zeno for patients with cancer. The Phase 2 results show that Zeno in combination with trastuzumab and vinorelbine is active in heavily pretreated HER2+ metastatic breast cancer patients who have progressed on multiple lines of anti-HER2 therapies Following from the Phase 2 interim analysis reported in October 2019, Merus has previously disclosed that it plans to only advance development in metastatic breast cancer with a partner and intends to focus efforts on the eNRGy trial of Zeno in NRG1 fusion cancers.