TABLE 1.
Patient demographics
| All, n (%) (n = 79) | Dose escalation cohortsa, n (%) (n = 64) | ACC confirmatory cohort, n (%) (n = 15) | All patients with ACC, n (%) (n = 40)b | |
|---|---|---|---|---|
| Median age (y, range) <65 ≥65 |
56.0 (23–76) 55 (70) 24 (30) |
54.8 (25–76) 43 (67) 21 (33) |
43.0 (23–71) 12 (80) 3 (20) |
48.5 (23–74) 31 (78) 9 (23) |
| Gender Male Female |
45 (57) 34 (43) |
35 (55) 29 (45) |
10 (67) 5 (33) |
21 (53) 19 (48) |
| Race/Ethnicity White Asian Black Other |
67 (85) 10 (13) 1 (1) 1 (1) |
61 (95) 1 (1) 1 (1) 1 (1) |
6 (40) 9 (60) 0 0 |
31 (78) 8 (20) 0 1 (3) |
| ECOG performance status 0 1 |
38 (48) 41 (52) |
37 (58) 27 (42) |
2 (13) 13 (87) |
19 (48) 21 (53) |
| Cancer type ACC Acinic cell carcinoma Breast Cancer Cholangiocarcinoma Colorectal cancer Osteosarcoma Prostate cancer Undifferentiated pleomorphic sarcoma T-cell ALL/LBL |
40 (51) 1 (1) 6 (8) 1 (1) 22 (28) 3 (4) 2 (3) 1 (1) 3 (4) |
28 (44) 1 (2) 6 (9) 1 (2) 22 (34) 3 (5) 2 (3) 1 (2) 0 |
12 (80) 0 0 0 0 0 0 0 3 (20) |
40 (100) — — — — — — — — |
| Lines of prior systemic therapy 1 line (L) 2L+ |
43 (54) 36 (46) |
26 (41) 38 (59) |
9 (60) 6 (40) |
21 (53) 19 (48) |
| Notch positivec | 43 (54) | 28 (44) | 15 (100) | 27 (68) |
Abbreviations: ACC = adenoid cystic carcinoma, ALL = acute lymphoblastic leukemia, LBL = lymphoblastic lymphoma, ECOG = Eastern Cooperative Oncology Group, y = years.
aAcross 12 dose-escalation cohorts (13 to 522 mg daily, and 250–500 mg twice daily).
bACC subgroup is included in the n = 79 total study population.
cNotch alteration status as determined by tumor molecular profiling and verified by next-generation sequencing.