FDA Grants Priority Review for Zanidatamab to Treat HER2-Positive Metastatic Biliary Tract Cancer

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If approved, zanidatamab will be the first HER2-targeted treatment indicated for individuals with this type of biliary tract cancer.

The FDA has accepted and granted priority review of the biologics license application (BLA) for zanidatamab — the human epidermal growth factor receptor 2 (HER2)- targeted bispecific antibody. The drug is aimed to treat individuals that were previously treated for unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).1

Illustration of the digestive system emphasizing the pancreas and gallbladder. Concept Human Anatomy, Digestive System, Physiology, Pancreas, Gallbladder - Image credit: Ян Заболотний | stock.adobe.com

Image credit: Ян Заболотний | stock.adobe.com

"The priority review designation for zanidatamab underscores the critical need for new treatment options for patients with locally advanced or metastatic HER2-positive BTC, a devastating disease with a poor prognosis,” said Rob Iannone, MD, MSCE, executive vice president and global head of research and development of Jazz Pharmaceuticals, in a news release. "Upon approval, zanidatamab will be the first HER2-targeted treatment specifically indicated for these patients, and we look forward to the opportunity to deliver this new treatment option to the BTC community.”1

In April 2024, Jazz Pharmaceuticals announced a submission to the FDA for a BLA, seeking accelerated approval for zanidatamab to treat BTC among individuals that were previously treated.2 Additionally, in December 2020, the FDA granted a breakthrough therapy designation to zanidatamab for the same treatment population.3

BTC accounts for more than 1% for all adult cancers, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma—all of which relate to a poor prognosis, according to study authors.1,2

Zanidatamab can aid patient outcomes as an investigational bispecific antibody that can bind 2 non-overlapping epitopes of HER2. The study authors noted that the process of biparatopic binding results in multiple mechanisms of action.1,2

The submission from Jazz Pharmaceuticals was based on results from the Phase 2b HERIZON-BTC-01 clinical trial (NCT04466891) that assessed zanidatamab among individuals with unresectable, locally advanced, or metastatic HER2-positive BTC. The study authors noted that the trial displayed a primary endpoint of 41.3% confirmed objective response rate by independent central review.1

In a previous phase 2 HERIZON-GEA-01 trial released in January 2023, researchers announced positive results of overall survival (OS) among individuals that received zanidatamab to treat HER2-expressing metastatic gastroesophageal adenocarcinoma. The results displayed that individuals treated with zanidatamab demonstrated 84% OS at 18 months, highlighting the multiple uses of zanidatamab.4

About The HERIZON-BTC-302

Trial Name: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

ClinicalTrials.gov ID: NCT06282575

Sponsor: Jazz Pharmaceuticals

Completion Date (Estimated): November 2029

The researchers are currently assessing the global, open-label, randomized HERIZON-BTC-302 Phase 3 trial (NCT06282575) that will evaluate the efficacy and safety of zanidatamab with standard-of-care therapy compared with standard-of-care therapy alone for first line of treatment for advanced or metastatic HER2-positive BTC. The study authors noted that the trial is ongoing and is open for enrollment.1

“Second-line (2L) BTC represents the first of multiple indications we are evaluating and we are excited about zanidatamab's potential as a new option for multiple HER2-expressing cancers, with ongoing Phase 3 trials in first line BTC, first line gastroesophageal adenocarcinoma, and previously treated breast cancer," Rob Iannone, MD, MSCE, executive vice president and global head of research and development of Jazz Pharmaceuticals, said in a news release.2

References
1. Zanidatamab Granted Priority Review for HER2-Positive Metastatic Biliary Tract Cancer. Jazz Pharmaceuticals. News release. May 29, 2024. Accessed May 29, 2024. https://investor.jazzpharma.com/news-releases/news-release-details/zanidatamab-granted-priority-review-her2-positive-metastatic
2. Jazz Pharmaceuticals Submits Biologics License Application for Zanidatamab to Treat Biliary Tract Cancer. Pharmacy Times. News release. April 3, 2024. Accessed May 29, 2024. https://www.pharmacytimes.com/view/jazz-pharmaceuticals-submits-biologics-license-application-for-zanidatamab-to-treat-biliary-tract-cancer
3. Zanidatamab Gets FDA Breakthrough Designation for HER2 Gene–Amplified Biliary Tract Cancer. Pharmacy Times. News release. December 1, 2020. Accessed May 29, 2024. https://www.pharmacytimes.com/view/zanidatamab-gets-fda-breakthrough-designation-for-her2-geneamplified-biliary-tract-cancer
4. Trial Results Demonstrate Significant Overall Survival With Zanidatamab in Adenocarcinoma. Pharmacy Times. News release. January 25, 2023. Accessed May 29, 2024. https://www.pharmacytimes.com/view/trial-results-demonstrate-significant-overall-survival-with-zanidatamab-in-adenocarcinoma
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