Table 3 Best overall response and progression-free survival.
From: A phase I trial of LXS196, a protein kinase C (PKC) inhibitor, for metastatic uveal melanoma
All LXS196 QD patients n = 38 | All LXS196 BID patients n = 30 | LXS196 300 mg BID (RDE) patients n = 18 | All LXS196 patients N = 68 | |
|---|---|---|---|---|
Best overall response (BOR), n (%) | ||||
Complete response (CR) | 0 | 1 (3.3) | 0 | 1 (1.5) |
Partial response (PR) | 2 (5.3) | 3 (10.0) | 2 (11.1) | 5 (7.4) |
Stable disease (SD) | 27 (71.1) | 18 (60.0) | 12 (66.7) | 45 (66.2) |
Progressive disease (PD) | 9 (23.7) | 6 (20.0) | 3 (16.7) | 15 (22.1) |
Unknowna | 0 | 2 (6.7) | 1 (5.6) | 2 (2.9) |
Overall response rate (ORR: CR + PR), n (%) [95% CI] | 2 (5.3) [0.6–17.7] | 4 (13.3) [3.8–30.7] | 2 (11.1) [1.4–34.7] | 6 (8.8) [3.3–18.2] |
Disease control rate (DCR: CR + PR + SD), n (%) [95% CI] | 29 (76.3) [59.8–88.6] | 22 (73.3) [54.1–87.7] | 14 (77.8) [52.4–93.6] | 51 (75.0) [63–84.7] |
Progression-free survival (PFS), n (%) | ||||
Number of PFS events | 38 (100.0) | 30 (100) | 18 (100) | 68 (100) |
Progression | 38 (100.0) | 28 (93.3) | 17 (94.4) | 66 (97.1) |
Deaths | 0 (0.0) | 2 (6.7) | 1 (5.6) | 2 (2.9) |
PFS percentiles (95% CI) | ||||
25th | 3.4 (1.7–3.5) | 1.9 (1.6–3.6) | 2.1 (0.8–3.6) | 2.0 (1.7–3.5) |
50th | 3.5 (3.5–5.4) | 4.1 (3.5–7.2) | 3.7 (2.1–5.4) | 3.6 (3.5–5.4) |
75th | 6.0 (3.6–7.3) | 12.9 (5.4–25.8) | 7.2 (3.7–25.8) | 7.2 (5.4–9.4) |
Kaplan–Meier estimates (%) PFS rate (95% CI) at | ||||
4 months | 36.8 (22.0–51.8) | 50.0 (31.3–66.1) | 44.4 (21.6–65.1) | 42.6 (30.8–54.0) |
6 months | 26.3 (13.7–40.8) | 33.3 (17.5–50.0) | 27.8 (10.1–48.9) | 29.4 (19.1–29.2) |
12 months | 0.0 (NE–NE) | 26.7 (12.6–43.0) | 22.2 (6.9–42.9) | 11.8 (5.5–20.6) |
