TABLE 3.
Efficacy and survival outcomes for patients with solid tumor
| All patients (n = 76)a |
ACC confirmatory cohort (n = 12)a | All patients with ACC (n = 40) | |
|---|---|---|---|
| Best overall response (n, %) Complete response Partial response Stable disease Progressive disease Unevaluable |
0 0 37 (49) 29 (38) 10 (13) |
0 0 3 (25) 7 (58) 2 (17) |
0 0 23 (58) 13 (33) 4 (10) |
| Clinical benefit rate (%, 95% CI) 3 months 6 months 9 months |
48.7 (37.0–60.4) 15.8 (8.4–26.0) 1.3 (0.0–7.1) |
25.0 (5.5–57.2) — — |
57.5 (40.9–73.0) 27.5 (14.6–43.9) 2.5 (0.1–13.2) |
| Progression-free survival No. of events (n, %) Median PFS (months, 95% CI) 3-month PFS 6-month PFS 9-month PFS 12-month PFS |
59 (78) 1.9 (1.4–3.2) 38.7 (26.5–50.6) 15.5 (7.5–26.0) 5.8 (1.7–14.3) 3.9 (0.7–11.6) |
10 (83) 1.4 (0.8–2.3) 10.9 (0.6–38.0) — — — |
35 (88) 2.5 (1.5–3.7) 46.8 (30.4–61.7) 18.6 (7.9–32.8) 6.2 (1.1–17.8) 6.2 (1.1–17.8) |
| Overall survival No. of deaths (n, %) Median OS (months, 95% CI) 6-month OS 12-month OS |
33 (43) 9.2 (6.3–18.4) 68.4 (54.4–78.9) 41.6 (28.0–54.7) |
4 (33) 5.4 (1.3–5.4) — — |
15 (38) 18.4 (8.3–NR) 72.4 (53.1–84.8) 57.3 (37.5–73.0) |
| Median follow-up time (months) | 5.4 | 1.8 | 5.9 |
Abbreviations: ACC = adenoid cystic carcinoma, CI = confidence interval, NR = not reached, PFS = progression-free survival, OS = overall survival.
a n = 3 patients with hematologic malignancies were excluded from above.