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Association details:
| Biomarker: | HER-2 mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Clinical Study of the Effcacy and Safety of Pyrotinib Combined with Chemotherapy in the First-Line Treatment of Patients with HER2-Mutant Advanced Non-Small Cell Lung Cancer
Excerpt:
...Definition of HER2-mutant NSCLC: insertion mutation and point mutation of HER2 gene were confirmed by gene detection of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other samples; 6. ...
Trial ID:
Source:
Title:
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
Excerpt:
...- HER2 insertion mutation-positive...
Trial ID:
More C2 evidence
Source:
Title:
Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
Excerpt:
...- Before enrollment, a documented confirmed presence of activating mutations in exon 20 of the HER2 gene must be provided....
Trial ID:
Source:
Title:
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
Excerpt:
...HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;...
Trial ID:
Source:
Title:
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
Excerpt:
...HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology....
Trial ID:
Source:
Title:
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Excerpt:
...- have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH, HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene mutation....
Trial ID:
Source:
Title:
Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation
Excerpt:
...Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive advanced Non-small cell lung cancer who failed prior therapies....
Trial ID:
Source:
Title:
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Excerpt:
...Confirmed HER2 mutation by Central Laboratory。 7....
Trial ID:
Source:
Title:
A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation
Excerpt:
...Confirmed HER2 mutation by Central Laboratoryincluded PCRFISH, NGS; 5. ...
Trial ID:
Less C2 evidence
Source:
Title:
Pyrotinib plus antiangiogenic agents for HER2-altered advanced non-small cell lung cancer: A retrospective real-world study
Published date:
09/23/2023
Excerpt:
In this study, pyrotinib plus antiangiogenic agents demonstrated promising efficacy and were tolerable in HER2-altered NSCLC patients.
Secondary therapy:
Angiogenesis inhibitor
DOI:
https://doi.org/10.1111/1759-7714.15118
Source:
Title:
First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial
Published date:
07/24/2023
Excerpt:
...we present efficacy and safety data from 48 patients with treatment-naive, advanced HER2-mutant NSCLC treated with the pan-HER receptor tyrosine kinase inhibitor pyrotinib (CF and CU cohorts) or physician’s therapy of choice (RWS cohort). In the phase 2 trial CF cohort (n = 28), the primary endpoint was reached with an objective response rate of 35.7% after pyrotinib treatment. Secondary endpoints included disease control rate (89.3%), median progression-free survival (PFS) (7.3 months), median overall survival (OS) (14.3 months
DOI:
https://doi.org/10.1038/s41591-023-02461-x
Source:
Title:
Pyrotinib plus antiangiogenic agents for HER2-altered advanced non-small cell lung cancer: A retrospective real-world study.
Published date:
05/25/2023
Excerpt:
In this retrospective real-world study, patients with HER2-altered NSCLC who received pyrotinib plus antiangiogenic agents as second or later-line treatment between November 2015 and January 2022 were reviewed….the ORR, DCR, median PFS, and median OS were 19.6% (21/107), 94.4% (101/107), 7.13 months (95% confidence interval [CI]: 6.26-8.01), and 19.50 months (95%CI: 12.83-26.17), respectively....Pyrotinib plus antiangiogenic agents demonstrated promising antitumor activity and a manageable safety profile in HER2-altered NSCLC patients.
Secondary therapy:
Angiogenesis inhibitor
DOI:
10.1200/JCO.2023.41.16_suppl.e21141
Source:
Title:
Outcome comparison of pyrotinib with current standard of care in the second/third line setting in advanced non-small cell lung cancer patients with HER2 mutation
Published date:
04/05/2023
Excerpt:
...we identified 182 patients with HER2 mutations….A total of 34, 27, and 9 patients received pyrotinib, chemotherapy alone, and ICI-based immunotherapy, respectively….Patients treated with pyrotinib had a significantly higher ORR (35.3% [12/34] vs. 8.3% [3/36], P = 0.006) and disease control rate (85.3% [29/34] vs. 52.8% [19/36], P = 0.003) than those treated with SoC. The best changes in tumor size from baseline are presented in Supplementary Figure 2B....Patients treated with pyrotinib showed significantly longer PFS (median, 7.0 vs. 3.6 months, P = 0.036 [Supplementary Figure 2C, https://links.lww.com/CM9/B291]; hazard ratio [HR] = 0.558, 95% confidence interval [CI]: 0.320–0.972, P = 0.039) and numerically longer OS... pyrotinib showed superior ORR, PFS, and OS compared with SoC as a second- or third-line treatment in patients with HER2-mutant advanced NSCLC.
DOI:
10.1097/CM9.0000000000002453
Source:
Title:
385P - Efficacy and safety of pyrotinib in untreated, advanced non-small cell lung cancer with HER2 mutations: A parallel, multi-center, multi-cohort patient-centric study (CTONG1702 and 1705)
Published date:
11/28/2022
Excerpt:
Pyrotinib exhibited promising efficacy and acceptable safety in untreated NSCLC patients with HER2 mutations. Benefits were also observed from the compassionate use of pyrotinib.
Source:
Title:
Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial
Published date:
02/01/2022
Excerpt:
In this multicenter, single-arm, phase II trial, stage IIIB-IV NSCLC patients harboring HER2 mutations….Patients with exon 20 and non-exon 20 HER2 mutations had ORRs of 17.7% and 25.0%, respectively….Pyrotinib exhibited promising efficacy and acceptable safety in NSCLC patients carrying exon 20 and non-exon 20 HER2 mutations and is worth further investigation.
DOI:
10.1186/s12916-022-02245-z
Source:
Title:
Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label, Single-Arm, Phase II Study
Published date:
07/02/2020
Excerpt:
Pyrotinib showed promising antitumor activity and an acceptable safety profile in chemotherapy-treated patients with HER2-mutant NSCLC.
DOI:
10.1200/JCO.20.00297
Source:
Title:
Safety and efficacy of pyrotinib in patients with NSCLC and other advanced solid tumors with activating HER2 alterations: A phase I basket trial.
Published date:
05/13/2020
Excerpt:
Pyrotinib demonstrated a manageable safety profile and encouraging efficacy in pts with heavily pre-treated HER2-mutant NSCLC.
DOI:
10.1200/JCO.2020.38.15_suppl.3510
Trial ID:
