Table 1 Demographics and baseline disease characteristics of patients receiving FGF401 as single agent or with spartalizumab
Demographics | Phase 1 single agent | Phase 2 single agent | All patients N = 160 | Combination | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
50 mg; N = 11 Fasted | 80 mg; N = 6 Fasted | 80 mg; N = 5 Fed | 120 mg; N = 26 Fasted | 120 mg; N = 19 Fed | 150 mg; N = 7 Fasted | Group 1 N = 30 | Group 2 N = 36 | Group 3 N = 20 | FGF401 80 mg + spartalizumab 300 mg N = 6 | FGF401 120 mg + spartalizumab 300 mg N = 6 | All Patients N = 12 | ||
Age, median, years | 64.0 (38–76) | 59.0 (40–66) | 61.0 (24–75) | 61.5 (36–80) | 60.0 (23–85) | 63.0 (44–79) | 60.5 (37–81) | 65.5 (41–81) | 65.0 (21–79) | 62.0 (21–85) | 66.0 (53–78) | 65.0 (44–73) | 65.0 (44–78) |
Sex, male, n (%) | 7 (63.6) | 5 (83.3) | 4 (80.0) | 23 (88.5) | 13 (68.4) | 7 (100) | 22 (73.3) | 29 (80.6) | 8 (40.0) | 118 (73.8) | 5 (83.3) | 2 (33.3) | 7 (58.3) |
Race, n (%) | |||||||||||||
 Asian | 9 (81.8) | 2 (33.3) | 2 (40.0) | 14 (53.8) | 10 (52.6) | 4 (57.1) | 30 (100) | 0 | 2 (10.0) | 73 (45.6) | 3 (50.0) | 5 (83.3) | 8 (66.7) |
 Caucasian | 2 (18.2) | 4 (66.7) | 3 (60.0) | 12 (46.2) | 8 (42.1) | 1 (14.3) | 0 | 21 (58.3) | 11 (55.0) | 62 (38.8) | 3 (50.0) | 1 (16.7) | 4 (33.3) |
 Others | 0 | 0 | 0 | 0 | 1 (5.3) | 2 (28.6) | 0 | 15 (41.7) | 7 (35.0) | 25 (15.6) | 0 | 0 | 0 |
BMI, median, (kg/m2) | 19.9 (19–27) | 25.2 (24–34) | 22.9 (20–29) | 24.6 (16–33) | 23.2 (19–29) | 21.5 (18–35) | 22.7 (17–31) | 25.8 (14–33) | 24.3 (17–33) | 24.2 (14–35) | 26.2 (20–36) | 22.4 (19–33) | 25.3 (19–36) |
ECOG performance status, n (%) | |||||||||||||
 0 | 3 (27.3) | 4 (66.7) | 1 (20.0) | 12 (46.2) | 8 (42.1) | 2 (28.6) | 10 (33.3) | 21 (58.3) | 10 (50.0) | 71 (44.4) | 5 (83.3) | 2 (33.3) | 7 (58.3) |
 1 | 8 (72.7) | 2 (33.3) | 4 (80.0) | 14 (53.8) | 11 (57.9) | 5 (71.4) | 20 (66.7) | 15 (41.7) | 10 (50.0) | 89 (55.6) | 1 (16.7) | 4 (66.7) | 5 (41.7) |
Previous therapy* | |||||||||||||
 Surgery | 9 (81.8) | 2 (33.3) | 4 (80.0) | 16 (61.5) | 12 (63.2) | 5 (71.4) | 15 (50.0) | 24 (66.7) | 13 (65.0) | 100 (62.5) | 5 (83.3) | 4 (66.7) | 9 (75.0) |
 Radiotherapy | 4 (36.4) | 1 (16.7) | 3 (60.0) | 9 (34.6) | 6 (31.6) | 3 (42.9) | 15 (50.0) | 7 (19.4) | 7 (35.0) | 55 (34.4) | 2 (33.3) | 1 (16.7) | 3 (25.0) |
 Medication | 10 (90.9) | 5 (83.3) | 5 (100) | 25 (96.2) | 17 (89.5) | 6 (85.7) | 30 (100) | 36 (100) | 20 (100) | 154 (96.3) | 6 (100) | 6 (100) | 12 (100) |
  Protein kinase inhibitors (axitinib, imatinib mesilate, lenvatinib, sorafenib, sorafenib tosylate, sunitinib) | 7 (63.6) | 4 (66.7) | 5 (100) | 20 (76.9) | 14 (73.7) | 5 (71.4) | 30 (100) | 36 (100) | 3 (15.0) | 124 (77.5) | 6 (100) | 6 (100) | 12 (100) |
  Monoclonal antibodies (nivolumab, pembrolizumab, ramucirumab, panitumumab) | 0 | 0 | 0 | 0 | 3 (15.8) | 0 | 0 | 0 | 2 (10.0) | 5 (3.1) | 0 | 1 (16.7) | 1 (8.3) |