Table 3 Rates of FN by cycle following treatment (FAS—As Randomized)
Cycle | Proposed biosimilar pegfilgrastim (APO-Peg) | US-licensed pegfilgrastim reference product (US-Neulasta®) | EU-approved pegfilgrastim reference product (EU-Neulasta®) | Total |
|---|---|---|---|---|
Cycle 1 | ||||
n/N (%) | 15/294 (5.1) | 6/148 (4.1) | 5/147 (3.4) | 26/589 (4.4) |
95% CI | 2.9–8.3 | 1.5–8.6 | 1.1–7.8 | 2.9–6.4 |
Cycle 2 | ||||
n/N (%) | 0/288 (0.0) | 1/146 (0.7) | 0/144 (0.0) | 1/578 (0.2) |
95% CI | 0.0–1.3 | 0.0–3.8 | 0.0–2.5 | 0.0–1.0 |
Cycle 3 | ||||
n/N (%) | 0/285 (0.0) | 0/146 (0.0) | 1/144 (0.7) | 1/575 (0.2) |
95% CI | 0.0–1.3 | 0.0–2.5 | 0.0–3.8 | 0.0–1.0 |
Cycle 4 | ||||
n/N (%) | 0/284 (0.0) | 0/144 (0.0) | 0/144 (0.0) | 0/572 (0.0) |
95% CI | 0.0–1.3 | 0.0–2.5 | 0.0–2.5 | 0.0–0.6 |
Cycle 5 | ||||
n/N (%) | 2/276 (0.7) | 0/143 (0.0) | 0/142 (0.0) | 2/561 (0.4) |
95% CI | 0.1–2.6 | 0.0–2.5 | 0.0–2.6 | 0.0–1.3 |
Cycle 6 | ||||
n/N (%) | 0/270 (0.0) | 0/143 (0.0) | 0/139 (0.0) | 0/552 (0.0) |
95% CI | 0.0–1.4 | 0.0–2.5 | 0.0–2.6 | 0.0–0.7 |
Overall | ||||
n/N (%) | 17/294 (5.8) | 7/148 (4.7) | 5/147 (3.4) | 29/589 (4.9) |
95% CI | 3.4–9.1 | 1.9–9.5 | 1.1–7.8 | 3.3–7.0 |