Ziihera: A New Hope For HER2-Positive Biliary Tract Cancer Patients

In November 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Ziihera® (zanidatamab-hrii), marking a significant advancement in the treatment of previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).

Breakthrough In Targeted Therapy

Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. It binds to two extracellular domains of the HER2 receptor, leading to receptor internalization and degradation.

This mechanism induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP), resulting in tumor growth inhibition and cell death.

Clinical Trial Results

The FDA’s accelerated approval was based on data from the HERIZON-BTC-01 trial, an open-label, multicenter, single-arm study involving 62 patients with unresectable or metastatic HER2-positive BTC. Patients had received at least one prior gemcitabine-containing regimen.

The study demonstrated an objective response rate (ORR) of 52% and a median duration of response (DOR) of 14.9 months, as determined by independent central review.

Ziihera Safety Profile

In the HERIZON-BTC-01 trial, serious adverse reactions occurred in 53% of patients treated with Ziihera. The most common adverse reactions (≥20%) included diarrhea, infusion-related reactions, abdominal pain, and fatigue.

A fatal adverse reaction of hepatic failure occurred in one patient. Permanent discontinuation due to an adverse reaction occurred in 2.5% of patients.

Collaborative Development And Future Prospects

Ziihera was developed through a collaboration between Jazz Pharmaceuticals and Zymeworks Inc., with BeiGene contributing in certain Asia Pacific territories.

Jazz acquired exclusive development and commercialization rights for zanidatamab in the U.S., Europe, Japan, and other territories in late 2022.

The approval of Ziihera represents the first FDA-approved therapy in Zymeworks’ pipeline and validates the company’s novel Azymetric™ bispecific platform technology.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.

Patient And Expert Perspectives

“BTC is a devastating disease with a poor prognosis and five-year survival rates under five percent in the metastatic setting,” said Dr. Rob Iannone, Executive Vice President and Chief Medical Officer of Jazz Pharmaceuticals.

“The approval of Ziihera offers the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for patients living with BTC.”

Stacie Lindsey, CEO and founder of the Cholangiocarcinoma Foundation, added, “The approval of Ziihera offers a promising treatment option. It provides patients and their loved ones the possibility of more time together and an improved quality of life, which is invaluable for the entire BTC community.”

The FDA approval of Ziihera marks a significant milestone in the treatment of HER2-positive BTC, offering a new targeted therapy option for patients with limited alternatives.

Ongoing clinical trials and collaborations aim to further explore the potential of zanidatamab in other HER2-expressing cancers, potentially broadening its impact in oncology.

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