Zanidatamab Data Highlight Durable Antitumor Activity in
HER2-Expressing Biliary Tract and Gastroesophageal Cancers at ASCO Gastrointestinal Cancers Symposium
Durable Responses Observed in Refractory Biliary Tract Cancer (BTC) and Gastroesophageal (GEA) Cancers
Enrollment Continues for Zanidatamab Global Pivotal Trial in BTC; Global Pivotal Trial in First-Line GEA
Slated to Open in Mid-2021
Vancouver, British Columbia (January 15,
2021) Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced new and updated clinical data for the HER2-targeted bispecific antibody zanidatamab, in
both HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA). The data are being presented today at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, taking place virtually
January 15 17, 2021.
Data presented today at ASCO GI continue to demonstrate the potential of zanidatamab in advanced HER2-expressing
cancers with high unmet need. The response rates and median duration of response in refractory BTC and GEA compare favorably to current standard of care and emerging treatments, said Diana Hausman, M.D., Chief Medical Officer at
Zymeworks. The BTC data were the basis of the recent Breakthrough Therapy designation granted by the FDA, a key step in helping zanidatamab become the first potential HER2-targeted therapy approved in
this indication. Furthermore, the activity in GEA supports our goal of establishing zanidatamab as the foundational HER2-targeted therapy for GEA and other HER2-positive cancers, not only in later stage disease, but also in earlier lines of
The following presentations are available to conference registrants on the ASCO conference website as well as to the general public at
Monotherapy and Chemotherapy Combinations in HER2-Expressing Gastroesophageal Cancer Clinical Results Abstract #164
(ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA): Results from a Phase 1 study (Presenter: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX; Rapid Abstract oral presentation on Friday, January 15, 11:30 am-12:15 pm ET)
HER2 is overexpressed in approximately 20% of GEA patients. For these patients, trastuzumab in
combination with chemotherapy is the only approved HER2-targeted therapy. Treatment options are currently limited if disease progression occurs after trastuzumab in combination with chemotherapy.
Findings from an ongoing Phase 1 study of zanidatamab in HER2-positive GEA were last presented in July 2020. New and updated results are being presented in a
Rapid Abstract oral presentation today, January 15th, at 11:30 am ET at the ASCO Gastrointestinal Cancers Symposium followed by a webcast at 5:00 pm ET to discuss the data, led by
zanidatamab study investigator Dr. Funda Meric-Bernstam, MD.