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Association details:
| Biomarker: | HER-2 expression |
|---|---|
| Cancer: | Biliary Tract Cancer |
| Drug: | Ziihera (zanidatamab-hrii) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Zymeworks Receives FDA Breakthrough Therapy Designation for HER2-Targeted Bispecific Antibody Zanidatamab in Patients with Biliary Tract Cancer
Published date:
11/30/2020
Excerpt:
Zymeworks Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab...This Breakthrough Therapy designation was based on an ongoing clinical trial of zanidatamab in patients with locally advanced (unresectable) and/or metastatic HER2-expressing tumors including BTC.
Source:
Title:
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Excerpt:
...Unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA (IHC 3+ or 2+ with or without gene amplification based upon local assessment or central assessment) -...
Trial ID:
Source:
Title:
Zymeworks Announces Positive Topline Data In The Pivotal HERIZON-BTC-01 Trial Of Zanidatamab
Published date:
12/12/2022
Excerpt:
Zymeworks Inc...announced positive topline results from the pivotal Phase 2b HERIZON-BTC-01 open-label, single-arm clinical trial investigating zanidatamab, a HER2-targeted bispecific antibody, as monotherapy in patients with previously treated HER2-amplified and expressing BTC....The positive topline results showed that 41.3% (95% CI: 30.4, 52.8) of enrolled patients with HER2-amplified and expressing (IHC2+ and 3+) disease achieved an objective response as assessed by independent central review. The median duration of response was 12.9 months (95% CI: 5.95 to not reached).
