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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Aidixi (disitamab vedotin) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
Excerpt:
...Core cohort: standard treatment is ineffective (the disease progresses or has no remission after treatment) or cannot tolerate standard treatment, or HER2 positive...
Trial ID:
Source:
Title:
Efficacy and safety of the recombinant humanized anti-HER2 monoclonal antibodyMMAE conjugate RC48-ADC in patients with HER2-positive or HER2-low expressing, metastatic breast cancer: a single-arm phase II study
Published date:
12/02/2023
Excerpt:
The median PFS was 5.7 months (95% CI: 4.6-6.9 months). The DCR was 64.2% (95% CI: 54.9%-72.6%). In the HER2-positive subgroup, the ORR and mPFS were 42.7% (95% CI: 32.0%-54.1%) and 6.3 months (95% CI: 4.9-7.6 months). In the HER2-low expressing subgroup, the ORR and mPFS were 29.0% (95% CI: 16.0%-46.1%) and 3.6 months (95% CI: 2.0-5.3 months)....RC48-ADC showed consistent efficacy in HER2-positive and HER2-low expressing subgroups.
Source:
Title:
71P - Efficacy and safety of disitamab vedotin after trastuzumab for HER2 -positive breast cancer: A real-world data of retrospective study
Published date:
11/27/2023
Excerpt:
Patients who received RC48 in ≤3 lines of treatment had significantly longer PFS than those who received it in ≥4 lines of treatment. The median PFS of RC48 in patients with trastuzumab resistance and refractoriness was 6.5 months and 5.6 months, respectively...RC48 exhibited promising efficacy in HER2-positive MBC with manageable toxicity...
Source:
Title:
397P - Efficacy and safety of the recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate RC48-ADC in patients with HER2-positive or HER2-low expressing, locally advanced or metastatic breast cancer: A single-arm phase II study
Published date:
10/16/2023
Excerpt:
The median PFS was 5.7 months. The DCR was 57.9%. In the HER2-positive subgroup, the ORR and mPFS were 34.5% and 6.3 months. In the HER2-low expressing subgroup, the ORR and mPFS were 22.2% and 3.6 months. In addition, the mPFS in the dual drug combination-treated group was longer than that in the single drug treatment group, with mPFS of 7.1 months and 4.6 months, respectively....RC48-ADC showed consistent efficacy in HER2-positive and HER2-low expressing subgroups.
Source:
Title:
A HER2 target antibody drug conjugate combined with anti-PD-(L)1 treatment eliminates hHER2+ tumors in hPD-1 transgenic mouse model and contributes immune memory formation
Published date:
10/16/2021
Excerpt:
The combination of RC48 and PD-1/PD-L1 immune checkpoint inhibition significantly enhanced tumor suppression and antitumor immunity. A novel HER2-targeting ADC combined with immune checkpoint inhibitors can achieve remarkable effects in mice and elicit long-lasting immune protection in a hHER2+ murine breast cancer model.
Secondary therapy:
PD1 inhibitor
DOI:
10.1007/s10549-021-06384-4
Source:
Title:
An open-label, multicenter, phase Ib study to evaluate RC48-ADC in patients with HER2-positive metastatic breast cancer.
Published date:
05/16/2018
Excerpt:
RC48-ADC has showed manageable safety and encouraging efficacy profiles in pts with HER2-positive MBC.
DOI:
10.1200/JCO.2018.36.15_suppl.1028
Trial ID:
