Jazz Pharmaceuticals and MD Anderson Announce Five-Year Collaboration to Evaluate Zanidatamab in HER2-Expressing Cancers

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Jazz Pharmaceuticals and the University of Texas MD Anderson Cancer Center have announced a five-year strategic research collaboration agreement to evaluate zanidatamab, Jazz's investigational human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, in multiple HER2-expressing cancers.

According to a company press release, the collaboration will combine MD Anderson's translational medicine and clinical research knowledge with Jazz's oncology drug development capabilities to investigate the potential of zanidatamab as a monotherapy and in combination with other treatments for patients with different tumor types and stages. This includes its possible applicability in early-stage breast cancer, treatment areas in which other HER2-directed therapies have failed, cancers with varying degrees of HER2-expression, and potentially rare, tissue-agnostic cancers.¹

In a study published in the Annals of Oncology on August 22, 2023, researchers from the MD Anderson Cancer Center evaluated HER2 expression by IHC in 4701 patients with different solid tumors. HER2-low expression was common across many solid tumors (41.1%). A significant number of patients without HER2 alterations (35.7%) had HER2 expression (≥1+). The findings suggest that many patients with HER2-low solid tumors might benefit from HER2-targeted therapies, according to the investigators.²

HER2-low is a newly defined category with HER2 1+ or 2+ expression by immunohistochemistry (IHC) and lack of HER2 gene amplification measured by in situ hybridization (ISH). Much remains unknown about the HER2-low status across tumor types and changes in HER2 status between primary and metastatic samples.²

"Current data indicates that zanidatamab has anti-tumor activity in multiple HER2-positive solid tumors, including positive results from a pivotal clinical trial for patients with HER2-amplified biliary tract cancers," said Funda Meric-Bernstam, MD, chair of investigational cancer therapeutics at MD Anderson, in a press release. "We are pleased to extend our research efforts with Jazz through this new collaboration, which aims to address significant unmet needs in HER2-expressing solid tumors and to look for safe and effective alternatives to chemotherapy in diseases like early-stage breast cancer."¹

MD Anderson was a key contributor to early investigations exploring the use of zanidatamab against an actionable target in the treatment of multiple tumor types and the subsequent Phase II HERIZON-BTC-01 trial, which evaluated zanidatamab for patients with treatment-refractory HER2-amplified biliary tract cancers.¹

Jazz and MD Anderson will establish a joint steering committee to oversee the collaboration, which will fund multiple studies over its five-year term. Research under the collaboration is expected to begin in late 2023 or early 2024. This effort builds upon a previous strategic collaboration between Jazz and MD Anderson focused on hematologic malignancies.¹

References

1. Jazz Pharmaceuticals. (n.d.). Jazz Pharmaceuticals and MD Anderson Announce Five-Year Collaboration to Evaluate Treatment Options for Hematologic Malignancies. Retrieved from https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-and-md-anderson-announce-five-year
2. Uzunparmak B, Haymaker C, Raso G, et al. HER2-low expression in patients with advanced or metastatic solid tumors. Annals of Oncology; Published online 22 August 2023. DOI: https://doi.org/10.1016/j.annonc.2023.08.005