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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | Biliary Tract Cancer |
| Drug: | zanidatamab (ZW25) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
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:
Exploratory clinical study of ZW25 in the treatment of advanced biliary tract tumors
Excerpt:
...In the central laboratory, the amplification of HER2 in the new biopsy or archive tissues of the subjects was detected by central in situ hybridization (ISH), and the results must be positive. ...
Trial ID:
More C2 evidence
Source:
Title:
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
Excerpt:
...- Subjects must test positive for HER2 amplification by ISH-assay at a central laboratory on a new biopsy or archival tissue....
Trial ID:
Less C2 evidence
Source:
Title:
132MO - Zanidatamab (ZW25; Zani) in patients (pts) with previously treated advanced human epidermal growth factor receptor 2 (HER2)-amplified biliary tract cancer (BTC): Asia subgroup analysis of the phase IIb HERIZON-BTC-01 study
Published date:
11/27/2023
Excerpt:
Objective response ratea, % (95% CI)...42 (28, 57)...Zani demonstrated durable tumor responses and a tolerable and manageable safety profile in pts in the Asia subgroup with Tx-refractory HER2-amplified advanced BTC…
Trial ID:
Source:
Title:
Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study
Published date:
06/02/2023
Excerpt:
Confirmed objective responses by independent central review were observed in 33 patients in cohort 1 (41·3% [95% CI 30·4-52·8])….Zanidatamab demonstrated meaningful clinical benefit with a manageable safety profile in patients with treatment-refractory, HER2-positive biliary tract cancer.
DOI:
10.1016/S1470-2045(23)00242-5
Trial ID:
Source:
Title:
Results from the pivotal phase (Ph) 2b HERIZON-BTC-01 study: Zanidatamab in previously-treated HER2‑amplified biliary tract cancer (BTC).
Published date:
05/25/2023
Excerpt:
...zani (20 mg/kg IV every 2 wks) in pts with HER2-amplified, locally advanced unresectable or metastatic BTC...In Cohort 1, cORR was 41% with median duration of response (DOR) of 12.9 months...Results of the pivotal HERIZON-BTC-01 study indicate that the HER2 bispecific antibody zani demonstrates rapid, durable responses with a manageable safety profile in pts with tx-refractory HER2-positive BTC.
DOI:
10.1200/JCO.2023.41.16_suppl.4008
Trial ID:
Source:
Title:
Zymeworks Announces Positive Topline Data In The Pivotal HERIZON-BTC-01 Trial Of Zanidatamab
Published date:
12/19/2022
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).
