^
Association details:
| Biomarker: | NRG1 fusion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | zenocutuzumab (MCLA-128) (HER2 inhibitor, HER3 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC
Published date:
05/06/2024
Excerpt:
...the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer.
Source:
Title:
Zenocutuzumab (Zeno) granted second Breakthrough Therapy Designation by the U.S. Food & Drug Administration
Published date:
07/05/2023
Excerpt:
Merus N.V...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) non-small cell lung cancer (NSCLC), following progression with prior systemic therapy.
Source:
Title:
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
Excerpt:
...Have histologically confirmed locally advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion detected by DNA- or RNA-based next generation sequencing in a tumor sample or in plasma-cell free DNA....
Trial ID:
Source:
Title:
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Excerpt:
...- Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories....
Trial ID:
More C2 evidence
Source:
Title:
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
Excerpt:
...- Patient with advanced metastatic solid tumor with documented NRG1 fusion determined in a qualified local laboratory by molecular profiling using methods such as next generation sequencing [DNA or RNA] or FISH as routinely performed at CLIA or other similarly-certified laboratories....
Trial ID:
Less C2 evidence
Source:
Title:
595P - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Published date:
11/27/2023
Excerpt:
In this updated analysis, Zeno provides robust and durable efficacy in advanced NRG1+ NSCLC, with a well-tolerated safety profile.
Trial ID:
Source:
Title:
1315MO - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Published date:
10/16/2023
Excerpt:
In this updated analysis, Zeno provides robust and durable efficacy in advanced NRG1+ NSCLC, with a well-tolerated safety profile.
Trial ID:
Source:
Title:
Efficacy and safety of zenocutuzumab, a HER2 x HER3 bispecific antibody, across advanced NRG1 fusion (NRG1+) cancers.
Published date:
05/26/2022
Excerpt:
Among the 71 pts with measurable disease, the INV-assessed confirmed ORR was 34% (90% CI, 25;44), including responses in NSCLC (35%; 14/40 pts), pancreas cancer (39%; 7/18 pts), breast cancer (2/4 pts), and cholangiocarcinoma (1/3 pts). Responses occurred at the first tumor assessment in 20/24 responders, and are ongoing in 13 pts....Zeno demonstrated robust and durable efficacy in pts with advanced NRG1+ cancer regardless of tumor histology.
DOI:
10.1200/JCO.2022.40.16_suppl.105
Trial ID:
