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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Pozenveo (poziotinib) (HER2 inhibitor, HER4 inhibitor, pan-EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
Excerpt:
...- Immunohistochemistry (IHC) HER2-positive BC that has progressed on trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) in the metastatic setting, unless there is recurrent disease within 12 months of adjuvant or neoadjuvant treatment....
Trial ID:
Source:
Title:
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
Excerpt:
...Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.`...
Trial ID:
Less C2 evidence
Source:
Title:
176P - Poziotinib for HER2-positive metastatic breast cancer (MBC): Final clinical efficacy and safety results for long-term follow-up of the phase II NOV120101-203 trial
Published date:
05/03/2022
Excerpt:
At the data cut-off, median PFS (95% CI) was 4.0 (3.0–4.4) months. Median OS (95% CI) was 17.7 (95% CI 12.4–20.8) months (68/102 events; 66.7%). OS rate (95% CI) at 36 and 60 months was 18 (10-28)% and 14 (7-24)%, respectively….Poziotinib showed clinically meaningful OS benefit for patients with HER2-positive mBC and the safety profile was as expected for tyrosine kinase inhibitors (TKIs). This encouraging result provide an important update on the clinical effectiveness and safety of poziotinib in HER2-positive mBC patients who were previously heavily treated.
Trial ID:
Source:
Title:
A Phase 2 study of poziotinib in patients with HER2-positive metastatic breast cancer heavily pre-treated with HER2-targeted therapy
Published date:
11/17/2020
Excerpt:
The ORRs were 27% and 26% with the corresponding median DORs of 5.6 and 13 months respectively. 3 patients in 16mg dose had a CR and another 2 patients had an unconfirmed CR. The DCRs were 50% and 70% in 2 cohorts along with median PFS of 4.1 and 5.8 months respectively....Poziotinib has demonstrated clinical activity in this dose-ranging study with tumor reduction shown in the majority of patients along with durable responses in this heavily pre-treated MBC patients.
