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Association details:
| Biomarker: | HER-2 exon 20 insertion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Pozenveo (poziotinib) (HER2 inhibitor, HER4 inhibitor, pan-EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Excerpt:
...- Cohort 2: Documented HER2 exon 20 insertion mutation (including duplication mutations) 7....
Trial ID:
Source:
Title:
Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC
Excerpt:
......
Trial ID:
More C2 evidence
Source:
Title:
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
Excerpt:
...- Cohort 2 and 4: Documented HER2 exon 20 insertion mutation...
Trial ID:
Source:
Title:
Study of Poziotinib in Japanese Patients With NSCLC
Excerpt:
...- Phase 2: Documented EGFR or HER2 exon 20 insertion mutations (including duplication mutations) in NSCLC patients -...
Trial ID:
Less C2 evidence
Source:
Title:
Real-World Clinical Outcomes for Patients with EGFR and HER2 Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer
Published date:
07/25/2023
Excerpt:
Among HER2 ex20ins patients, 41/47 had stage IV disease….Of the seven patients who received poziotinib, two had a partial response and five had stable disease, and the one patient who received mobocertinib had stable disease, whereas one of the four patients who received afatinib had stable disease.
DOI:
https://doi.org/10.3390/curroncol30080515
Source:
Title:
Poziotinib in Treatment-Naïve Non-Small-Cell Lung Cancer Harboring HER2 Exon 20 Mutations: ZENITH20-4, A Multicenter, Multicohort, Open-label Phase 2 Trial (Cohort 4)
Published date:
03/21/2023
Excerpt:
Poziotinib demonstrated clinically meaningful efficacy with a manageable toxicity profile for treatment-naïve NSCLC patients harboring HER2 exon 20 mutations.
DOI:
https://doi.org/10.1016/j.jtho.2023.03.016
Trial ID:
Source:
Title:
3400 / 6 - Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations
Published date:
03/09/2022
Excerpt:
23 patients with tumor tissue confirmed NSCLC harboring HER2 exon 20 insertion mutations were studied….15 of the 16 (94%) patients demonstrated a decrease in mVAF at C3D1 compared to the mVAF at baseline. 12 of 15 patients demonstrated an >50% reduction in mVAF at C3D1, with 7 of the 12 patients showing >95% reduction in mVAF at C3D1 with clinical outcomes of 5 PRs, 1 non-CR/non-PD and 1 SD....Baseline plasma ctDNA genotyping correlated with tumor tissue based NGS in an NSCLC patient population with HER2 mutations. Poziotinib treatment resulted in mVAF reduction, which correlated with clinical response per RECIST1.1.
Source:
Title:
Spectrum Pharmaceuticals Presents Positive Data for Poziotinib in First-line NSCLC Patients with HER2 Exon 20 Insertion Mutations
Published date:
03/07/2022
Excerpt:
...Spectrum Pharmaceuticals...today announced the presentation of safety and efficacy results from Cohort 4 of the ZENITH20 clinical trial. This data is from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib. These results showed a confirmed objective response rate (ORR) of 41% (95% CI:30%-54%), as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the TKI class.
Trial ID:
