Table 6.
Summary of phase III clinical trials evaluating the safety, efficacy, and pharmacokinetics of trastuzumab biosimilars under investigation in patients with HER2+ breast cancer.
| Ref. | Chemotherapy Regimens | Cohort Size | Phase | Settings | Endpoints | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| %ORR | AUC, μg × h/mL |
PFS, mo | %PR | %CR | Cmax, μg/mL | AEs/SAEs | |||||
| [52] Xu et al., 2021 |
HLX02 (n = 324) vs. TRZ (n =325) plus docetaxel |
649 | III (equivalence study) | Patients with HER2+ recurrent or metastatic BC | ORR24: 71.3 vs. 71.4% | 11.7 vs. 10.6 |
66 vs. 67.7 | 5.2 vs. 3.7 | Grade 3 or higher TEAEs: 85.8 vs. 86.4%; Serious TEAEs: 23.8 vs. 24.9%; Cardiac disorders of special interest: 4.9 vs. 5.2% |
||
| [55] Apsangikar et al., 2017 |
TRASTUREL vs. TRZ plus paclitaxel (1:1) | 148 | III | Patients with metastatic breast cancer | 48.44% vs. 44.44% | 24298.29 vs. 25809.33 | 229.02 vs. 210.68 | AEs: 68.29%vs. 59.09% | |||
| [58] Alexeev et al., 2020 |
BCD-022 (115) vs. TRZ (110) plus paclitaxel |
225 | III | Female patients with no previous treatment for metastatic HER2(+) breast cancer | 49.6% vs. 43.6% | AEs: 93.81% vs. 94.55% | |||||
TRZ: Trastuzumab, ORR: Objective Response Rate, PFS: Progression-Free Survival, PR: Partial Response, CR: Complete Response.