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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations (SUMMIT)

Excerpt:
...Documented HER2 or EGFR exon 18 mutation...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

559P - Neratinib in HER2-mutant, recurrent/metastatic cervical cancer (R/M CC): Updated findings from the phase 2 SUMMIT basket trial

Published date:
09/05/2022
Excerpt:
We describe updated findings from the HER2-mutant R/M CC cohort from SUMMIT…Median duration of neratinib therapy was 3.7 months...ORR was 18% (95% CI 5–40%) and CBR was 46% (95% CI 24–68%). Median PFS was 5.1 months (95% CI 1.7–7.2 months)….These encouraging results support the clinical benefit of neratinib in this patient population
Secondary therapy:
loperamide
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial

Published date:
07/27/2020
Excerpt:
"Neratinib monotherapy showed evidence of activity in heavily pretreated patients with HER2-mutant cervical cancer, with no new safety signals"
DOI:
10.1016/j.ygyno.2020.07.025
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial

Published date:
07/25/2020
Excerpt:
Neratinib monotherapy showed evidence of activity in heavily pretreated patients with HER2-mutant cervical cancer, with no new safety signals.
DOI:
10.1016/j.ygyno.2020.07.025
Evidence Level:
Sensitive: D – Preclinical
Title:

Establishment of a high-fidelity patient-derived xenograft model for cervical cancer enables the evaluation of patient's response to conventional and novel therapies

Published date:
09/09/2023
Excerpt:
In a PDX model, a novel therapeutic strategy, the combination of ACT and neratinib, was shown to effectively inhibit the growth of PDX tumors derived from CC patients with HER2-mutation.
DOI:
10.1186/s12967-023-04444-5
Evidence Level:
Sensitive: D – Preclinical
Title:

Whole-exome sequencing of cervical carcinomas identifies activating ERBB2 and PIK3CA mutations as targets for combination therapy

Published date:
10/19/2019
Excerpt:
Finally, we found afatinib and neratinib to be highly active against human HER2 mutant cervical cancer xenografts. Indeed, as shown in Fig. 3C, daily oral administration of afatinib at 25 mg/kg or neratinib at 40 mg/kg showed a significant tumor growth inhibition in the treated group after 30 d of treatment (P = 0.001 and P = 0.0002, respectively) and significantly improved the overall survival when compared to the control group (P = 0.0001 and P = 0.0001, respectively) (Fig. 3D).
DOI:
10.1073/pnas.1911385116