Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, presentations on new and updated data from trials of zanidatamab at the European Society for Medical Oncology (ESMO) Congress 2024 from September 13-17, 2024, in Barcelona, Spain.
New and updated data with longer follow-up, including overall survival findings, will be presented from an ongoing Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA). Additional data from a Phase 2 study evaluating zanidatamab in combination with chemotherapy and bevacizumab as first-line treatment in HER2-positive metastatic colorectal cancer demonstrating encouraging antitumor activity will be presented as a mini-oral presentation at the congress.
“We look forward to presenting new and more mature data from our oncology solid tumor clinical development program at this year’s ESMO congress, in particular for zanidatamab in HER2-positive metastatic gastroesophageal adenocarcinoma,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “We look forward to continuing to advance our clinical development program for zanidatamab in GEA, including the Phase 3 clinical trial expected to read out in the second quarter of 2025 that could support global regulatory submissions.”
The full ESMO abstracts for posters are available at:
https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation
The full ESMO abstracts for presentations are available at: ESMO Congress 2024 – Conference Calendar – ESMO Congress 2024 (ctimeetingtech.com)
The list of partner-supported presentations at the 2024 ESMO Congress includes:
Zanidatamab Presentations
| Topic | Author | Presentation Details |
| Zanidatamab + Chemotherapy for First-Line (1L) Treatment of HER2+Advanced or Metastatic Gastro-oesophageal Adenocarcinoma(mGEA): New and Updated Data Froma Phase 2 Trial | Elena Elimova, et al. | Type: Poster Date: Monday, September 16 Presentation #: 1432P |
| Zanidatamab (Zani) + Chemotherapy(CT) in First-Line (1L) HumanEpidermal Growth Factor Receptor 2-Positive (HER2+) Advanced/MetastaticColorectal Cancer (mCRC) | Sun Young Rha, et al. | Type: Mini Oral session Date: Saturday, September 14, 2:50-2:55 p.m. CEST Presentation #: 516MO |
| HERIZON-BTC-02: A Phase 3 Study ofZanidatamab With Standard-of-Care(SOC) Therapy vs SOC Alone ForFirst-Line (1L) Treatment of HumanEpidermal Growth Factor Receptor 2(HER2)-Positive Advanced/MetastaticBiliary Tract Cancer (BTC) | TescaMacarulla, et al. | Type: Poster Date: Monday, September 16 Presentation #: 62TiP |
About Zanidatamab
Zanidatamab is an investigational dual HER2-targeted bispecific antibody that simultaneously binds to two distinct sites on HER2, known as biparatopic binding. This unique design and enhanced binding results in multiple mechanisms of action, including HER2 and HER3 signal inhibition, removal of HER2 protein from the cell surface and enhanced immune effector functions, such as complement-dependent cytotoxicity (CDC), which leads to encouraging antitumor activity. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The U.S. Food and Drug Administration (FDA) has granted priority review for the Biologics License Application (BLA) for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) with a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.
