Skip to main content

Advertisement

Table 4 Mean ANC values for planned sampling days in cycle 1 (FAS-As Randomized and FAS-As Treated)

From: Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

Characteristics Proposed biosimilar pegfilgrastim (APO-Peg) N = 294 US-licensed pegfilgrastim reference product (US-Neulasta®) N = 148 EU-approved pegfilgrastim reference product (EU-Neulasta®) N = 147 Total N = 589
FAS-As Randomized
 Day on which the peak ANC value was reached
  N 294 148 147 589
  Mean (SD) 3.4 (2.3) 3.1 (0.6) 3.1 (1.4) 3.2 (1.8)
  Median 3.0 3.0 3.0 3.0
  Minimum–maximum 1–24 3–9 1–18 1–24
  95% CIs of mean 3.1–3.6 3.0–3.2 2.9–3.4 3.1–3.4
 Peak ANC value (× 109/L)
  N 294 148 147 589
  Mean (SD) 28.4 (9.5) 29.9 (10.2) 28.7 (9.3) 28.9 (9.6)
  Median 27.7 29.4 27.9 28.0
  Minimum–maximum 3.9–60.5 11.3–88.0 5.8–55.9 3.9–88.0
  95% CIs of mean 27.3–29.5 28.3–31.6 27.2–30.2 28.1–29.7
 Day on which the depth of ANC nadir was reached
  N 294 148 147 589
  Mean (SD) 7.1 (1.8) 7.1 (0.6) 7.3 (2.1) 7.1 (1.7)
  Median 7.0 7.0 7.0 7.0
  Minimum–maximum 1–21 6–11 6–21 1–21
  95% CIs of mean 6.9–7.3 7.0–7.2 7.0–7.7 7.0–7.3
 Depth of ANC nadir (× 109/L)
  N 294 148 147 589
  Mean (SD) 0.6 (1.1) 0.4 (0.6) 0.4 (0.7) 0.5 (0.9)
  Median 0.2 0.2 0.1 0.2
  Minimum–maximum 0.0–9.8 0.0–3.4 0.0–6.0 0.0–9.8
  95% CIs of mean 0.4–0.7 0.3–0.5 0.3–0.5 0.4–0.6
 Day on which recovery of ANC was reached
  N 267 136 137 540
  Mean (SD) 9.4 (2.0) 9.5 (2.1) 9.2 (1.0) 9.4 (1.8)
  Median 9.0 9.0 9.0 9.0
  Minimum–maximum 6–25 8–22 8–13 6–25
  95% CIs of mean 9.2–9.7 9.1–9.8 9.0–9.4 9.2–9.5
Characteristics Proposed biosimilar pegfilgrastim (APO-Peg) N = 298 US-licensed pegfilgrastim reference product (US-Neulasta®) N = 147 EU-approved pegfilgrastim reference product (EU-Neulasta®) N = 147 Total
N = 589
FAS-As Treated
 Day on which the peak ANC value was reached
  N 298 147 144 589
  Mean (SD) 3.4 (2.3) 3.1 (0.5) 3.1 (1.4) 3.2 (1.8)
  Median 3.0 3.0 3.0 3.0
  Minimum–maximum 1–24 3–9 1–18 1–24
  95% CIs of mean 3.1–3.6 3.0–3.2 2.9–3.4 3.1–3.4
Peak ANC value (× 109/L)
  N 298 147 144 589
  Mean (SD) 28.5 (9.6) 29.7 (10.2) 28.8 (9.2) 28.9 (9.6)
  Median 27.7 28.6 28.3 28.0
  Minimum–maximum 3.9–60.5 11.3–88.0 5.8–55.9 3.9–88.0
  95% CIs of mean 27.4–29.6 28.1–31.4 27.3–30.4 28.1–29.7
Day on which the depth of ANC nadir was reached
  N 298 147 144 589
  Mean (SD) 7.1 (2.0) 7.1 (0.6) 7.2 (1.8) 7.1 (1.7)
  Median 7.0 7.0 7.0 7.0
  Minimum–maximum 1–21 6–11 6–21 1–21
  95% CIs of mean 6.9–7.4 7.0–7.2 6.9–7.5 7.0–7.3
Depth of ANC nadir (× 109/L)     
  N 298 147 144 589
  Mean (SD) 0.6 (1.1) 0.4 (0.6) 0.4 (0.7) 0.5 (0.9)
  Median 0.2 0.2 0.1 0.2
  Minimum–maximum 0.0–9.8 0.0–3.4 0.0–6.0 0.0–9.8
  95% CIs of mean 0.4–0.7 0.3–0.5 0.3–0.5 0.4–0.6
 Day on which recovery of ANC was reached
  N 270 135 135 540
  Mean (SD) 9.4 (2) 9.4 (2.1) 9.2 (1.0) 9.4 (1.8)
  Median 9.0 9.0 9.0 9.0
  Minimum–maximum 6–25 8–22 8–13 6–25
  95% CIs of mean 9.2–9.7 9.1–9.8 9.0–9.4 9.2–9.5