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Association details:
| Biomarker: | HER-2 overexpression |
|---|---|
| Cancer: | Gastroesophageal Junction Adenocarcinoma |
| Drug: | Her-VAXX (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of IMU-131(HER-Vaxx) and Chemotherapy Compared to Chemotherapy Only in Patients With HER2 Positive Advanced Gastric Cancer
Excerpt:
...HER2/neu overexpression (3+ by immunohistochemistry (IHC) or if IHC 2+ confirmed by fluorescent in situ hybridization [FISH] or chromogenic in situ hybridization [CISH])....
Trial ID:
Source:
Title:
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/Neu Over-Expressing Gastric Cancer (nextHERIZON)
Excerpt:
...Age ≥ 18 years with confirmed diagnosis of advanced or metastatic HER2/neu overexpressing gastric or GEJ adenocarcinoma; 2....
Trial ID:
Less C2 evidence
Source:
Title:
HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma— Overall survival analysis.
Published date:
01/17/2023
Excerpt:
Analysis showed a 42% survival benefit for patients treated with HER-Vaxx plus chemotherapy compared to chemotherapy alone. This translated into an OS HR of 0.580 (80% 2-sided CI: 0.362, 0.927) with a statistically significant p-value of 0.066. The median OS for patients receiving HER-Vaxx plus chemotherapy was 13.9 (7.5, 14.3) months, compared to 8.3 (6.0, 9.6) months in patients treated with chemotherapy alone....These data demonstrate that in patients with HER2 over-expressing gastric/GEJ cancer active HER2 immunization with HER-Vaxx is safe and provides relevant clinical benefit over standard of care chemotherapy.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2023.41.3_suppl.289
Trial ID:
Source:
Title:
74MO - HERIZON overall survival results: A study of IMU-131, a HER2 targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2 overexpressing metastatic or advanced gastric/GEJ cancer
Published date:
11/28/2022
Excerpt:
...patients with HER2/neu overexpressing metastatic or advanced gastric/GEJ cancer who were naïve to HER2 therapy...Analysis showed a 42% survival benefit for patients treated with IMU-131 plus chemotherapy compared to chemotherapy alone….The median OS for patients receiving IMU-131 plus chemotherapy was 13.9 months, compared to 8.3 months in patients treated with chemotherapy alone....These results demonstrate that active immunization with the B-lymphocyte stimulating HER2 vaccine, IMU-131 (HER-Vaxx), may provide treatment benefits consistent with traditional monoclonal antibodies with a corresponding adaptive immune response without added toxicity.
Trial ID:
Source:
Title:
CT107 - A PHASE 1B/2 OPEN-LABEL STUDY WITH RANDOMIZATION IN PHASE 2 OF IMU-131 HER2/NEU PEPTIDE VACCINE PLUS STANDARD OF CARE CHEMOTHERAPY IN PATIENTS WITH HER2/NEU OVEREXPRESSING METASTATIC OR ADVANCED ADENOCARCINOMA OF THE STOMACH OR GASTROESOPHAGEAL JUNCTION
Published date:
03/10/2021
Excerpt:
Fourteen patients with HER2/neu overexpressing GEA were enrolled...One patient showed complete response, 5 showed partial response and 4 stable disease as their best response...IMU-131 was well tolerated and safe.
Trial ID:
