Table 1.
Nelipepimut-S dosing regimens for breast cancer node-positive and node-negative patient groups by trial design
| Patient group | No. of patients | Months vaccinated |
|---|---|---|
| Node-positive | ||
| 100.250.6a | 4b | 0, 1, 2, 3, 4, 5 |
| 500.250.4 | 6 | 0, 1, 2, 5 |
| 500.250.6 | 5 | 0, 1, 2, 3, 4, 5 |
| 1000.250.4 | 11 | 0, 1, 2, 5 |
| 1000.250.6 | 27c | 0, 1, 2, 3, 4, 5 |
| Node-negative | ||
| 500.125.3 | 10 | 0, 1, 5 |
| 500.125.4 | 9 | 0, 1, 2, 5 |
| 500.250.4 | 12 | 0, 1, 2, 5 |
| 500.250.6 | 13 | 0, 1, 2, 3, 4, 5 |
| 1000.250.6 | 11 | 0, 1, 2, 3, 4, 5 |
| Total | 108 | |
aNomenclature signifies peptide dose, granulocyte–macrophage colony-stimulating factor (GM-CSF) dose, and number of inoculations (i.e. 100.250.6 describes 100 µg of nelipepimut-S mixed with 250 µg of GM-CSF administered in 6 monthly inoculations).
bOne patient assigned to the 100.250.6 group withdrew before completing the primary vaccination series. She was monitored in the vaccine arm on an intention-to-treat basis.
cOne patient assigned to the optimal dose group received only a single inoculation secondary to a hepatitis C infection. She was monitored in the vaccine arm on an intention-to-treat basis for the overall disease-free survival analysis but was not included in subsequent analyses evaluating optimal dosing.