Table 1 Patient characteristics
Parameter | 50 mg/m2 (N = 4) | 100 mg/m2 (N = 5) | 200 mg/m2 (N = 3) | 300 mg/m2 (N = 3) | 400 mg/m2 (N = 3) | 500 mg/m2 (N = 7) | 600 mg/m2 (N = 1) | Total (N = 26) | % |
|---|---|---|---|---|---|---|---|---|---|
Gender | |||||||||
 Male | 3 | 3 | 2 | 1 | 3 | 6 | 0 | 18 | 69 |
 Female | 1 | 2 | 1 | 2 | 0 | 1 | 1 | 8 | 31 |
Race | |||||||||
 Caucasian | 3 | 4 | 3 | 3 | 2 | 6 | 1 | 23 | 89 |
 Black | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 3 | 11 |
Age (years, at screening) | |||||||||
 Mean (SD) | 64.645 (11.7737) | 60.716 (13.5373) | 62.387 (20.6538) | 68.227 (15.4956) | 74.25 (11.0807) | 67.104 (9.5240) | 65.92 (NA) | 65.9 (12.14) |  |
 Median | 66.92 | 59.43 | 61.370 | 70.500 | 69.00 | 66.98 | 65.92 | 66.9 |  |
 Range | 49.84–74.9 | 41.0–77.3 | 42.26–83.53 | 51.72–82.76 | 66.77–86.98 | 53.65–79.69 | 65.92 | 41–87 |  |
Type of malignancy | |||||||||
 CLL | 4 | 4 | 4 | 3 | 3 | 5 | 0 | 23 | 89 |
 Multiple Myeloma | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 11 |
Time from diagnosis to first samalizumab dose (days) | |||||||||
 Mean (SD) | 3672.3 (3323.28) | 1556.6 (1571.86) | 3017.0 (912.22) | 1577.3 (1010.13) | 3371.0 (2045.69) | 1850.4 (1190.99) | 1451.0 (NA) | 233 (1817.1) |  |
 Median | 2510.5 | 813.0 | 2922.0 | 1264.0 | 3061.0 | 1649.0 | 1451.0 | 1887 |  |
 Range | 1148–8520 | 43–4200 | 2156–3973 | 761–2707 | 1498–5554 | 154–3123 | 1451–1451 | 154–8520 |  |
 Patients with previous chemotherapy | 3 | 3 | 3 | 3 | 2 | 7 | 1 | 22 | 85 |
 Patients with previous radiation | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 8 |
 Patients without prior chemotherapy or radiation treatments | 1 | 2 | 0 | 0 | 1 | 0 | 0 | 4 | 15 |
Study completion | |||||||||
 Yes | 2 | 3 | 0 | 1 | 1 | 2 | 0 | 9 | 34.6 |
 No | 2 | 2 | 3 | 2 | 2 | 5 | 1 | 17 | 65.4 |
Reason for non-completion | |||||||||
 Treatment-emergent adverse event | 1 | 0 | 1 | 2 | 1 | 0 | 0 | 5 | 19.2 |
 Patient requested to withdraw | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 4 | 15.4 |
 Lack of efficacy | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 3 | 11.5 |
 Investigator considered it advisable/in the patient’s best interest | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 7.7 |
 Patient did not complete follow up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 3.8 |
 Death (not related to study drug) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 3.8 |
 Positive antidrug antibody serology | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 3.8 |