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Association details:
| Biomarker: | HER-2 underexpression |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | trastuzumab mafodotin (IKS014) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.
Excerpt:
...HER2 low expression: IHC1+, IHC2+/FISH- Phase Ib dose-expanded study: Histologically or cytologically confirmed breast cancer patients who have failed to prior trastuzumab treatment....
Source:
Title:
FS-1502, an anti-HER2 ADC, in Patients with HER2-Expressing Advanced Solid Tumors: A Phase 1a Dose-Escalation Study
Published date:
11/22/2022
Excerpt:
Patients with HER2-expresssing advanced solid tumors who had failed prior standard of care therapies were enrolled...ORRs were observed at doses at or above 1.0 mg/kg with an ORR of 66.7% (4/6) at the recommended phase 2 dose (RP2D) of 2.3 mg/kg. Median duration of response (DoR) across all dose levels was 9.2 months (95%CI 5.6-NR)...FS-1502 was well-tolerated and demonstrated encouraging antitumor activity in both HER2-high and -low patients.
Trial ID:
