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    Association details:
    Biomarker:HER-2 mutation
    Cancer:Cervical Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    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:
    SUMMIT
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2022
    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:
    SUMMIT
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Gynecol Oncol
    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:
    SUMMIT
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Gynecol Oncol
    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
    Source:
    J Transl Med
    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
    Source:
    Proc Natl Acad Sci U S A
    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