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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
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:
ZENITH20 is an open-label, multicohort, multicenter global phase 2 trial. ZENITH20-C4 enrolled treatment-naïve NSCLC patients with tumors harboring HER2 exon 20 insertions. Poziotinib was administered 16 mg once daily (QD) or 8 mg twice daily (BID)....Among all subtypes of HER2 exon 20 insertions, 7 patients (9%) harboring tumors with G778_P780dupGSP had the best clinical outcomes (ORR, 71%).
DOI:
https://doi.org/10.1016/j.jtho.2023.03.016
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1172P - High activity of poziotinib in G778_P780dup HER2 exon 20 insertion mutations in non-small cell lung cancer (NSCLC)

Published date:
09/05/2022
Excerpt:
ZENITH20 is a prospective global phase II study. Cohorts 2 and 4 (C2, C4) include adults with locally advanced or metastatic NSCLC harboring HER2 ex20ins....12/14 patients were evaluable and showed 100% partial response (PR) with a median DoR of 5.5 months (range 2.9-14.1; 3/12 patients had a DoR > 6 mo [C2: n=1; C4: n=2]). Median progression-free survival (PFS) was 7.8 mo (C2: 7.6; C4: 9.8)….Poziotinib is highly active in G778, a common HER2 ex20ins alteration, in both treatment-naïve and previously treated patients with NSCLC.
Trial ID: