Table 1.
Studies to date of trastuzumab biosimilars.
| Biosimilar [Reference] |
Population (N) | Primary Outcome |
Primary Outcome Results | PFS |
|---|---|---|---|---|
| SB3 [25] |
NA + A (800) |
bpCR | SB3 51.7% vs. TRZ 42.0% RR 1.26 (95% CI 1.09–1.46) |
- |
| ABP-980 [18] |
NA + A (725) |
tpCR | ABP-980 48% vs. TRZ 41% RR 1.19 (90% CI 1.03–1.37) |
- |
| PF-05280014 [22] |
MET (707) |
ORR | PF-05280014 62.5% vs. TRZ 66.5% RR: 0.94 (95% CI 0.84–1.05) |
PF-05280014 12.16 vs. TRZ 12.06 months RR: 1.00 (95% CI 0.80–1.26) |
| NA (226) |
Cycle 5 trough > 20 ug/mL | PF-05280014 92.1% vs. TRZ 93.3% | - | |
| CT-P6 [24] |
NA + A (549) |
tpCR | CT-P6 46.8% vs. TRZ 50.4% RR: 0.93 (95% CI 0.78–1.11) |
- |
| MET (475) |
ORR | CT-P6 57% vs. TRZ 62% | CT-P6 11.07 vs. TRZ 15.52 months | |
| BCD-022 [26] |
MET (126) |
ORR | BCD-022 49.6 vs. TRZ 43.6% | - |
| MYL-1401O [16] |
MET (500) |
ORR | MYL-1401O 69.6% vs. TRZ 64.0% RR: 1.09 (90% CI 0.97–1.21) |
At 48 weeks: MYL-1401O 44.3% vs. TRZ 44.7% RR: 0.95 (95% CI 0.71–1.25) |
| TX05 [20] |
NA (674) |
tpCR | TX05 48.8% vs. TRZ 45.3% RR: 1.08 (95% CI 0.92–1.27) |
- |
| EG 12014 [19] |
NA + A (807) |
tpCR | tpCR rates n/a in abstract RR: 0.99 (90% CI 0.88–1.12) |
- |
| HLX02 [27] |
MET (649) |
ORR | HLX02 71.3% vs. TRZ 71.4% | HLX02 11.7 vs. TRZ 10.6 months HR: 0.83 (p = 0.09) |
| HD201 [17] |
NA + A (502) |
tpCR | HD201 49.8% vs. TRZ 51.9% | - |
NA (neoadjuvant), A (adjuvant), MET (metastatic), bpCR (breast pathological complete response), tpCR (total pathological complete response), ORR (overall response rate), TRZ (reference trastuzumab), RR (relative risk), PFS (progression free survival).