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Association details:
| Biomarker: | HR negative |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | QL1209 (pertuzumab biosimilar) (HER2 dimerization inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
245P - Neoadjuvant QL1209 (a pertuzumab biosimilar) compared with pertuzumab plus trastuzumab and docetaxel in early or locally advanced, HER2-positive, ER(-)/PR(-) breast cancer: A multicenter, randomized, double-blind, equivalence, phase III study
Published date:
10/16/2023
Excerpt:
Here we present the results of the phase 3 study comparing the efficacy, safety, immunogenicity of QL1209 with P in the neoadjuvant setting for early HER2-positive breast cancer....tpCR (by IRC) was observed in 109 (42.7%) pts with QL1209 and 117 (45.2%) pts with P; ratio of tpCR (QL1209:P) 0.946 (90% CI: 0.8-1.11), p=0.014….QL1209 demonstrated equivalence to P in efficacy and showed comparable safety profile and immunogenicity in patients with early or locally advanced HER2-positive breast cancer.
Trial ID:
