Table 4.
Summary of efficacy endpoints: Phase 1b and Phase 2.
| Phase 1b | Phase 2 | ||||||
|---|---|---|---|---|---|---|---|
| n (%) | ARRY-382 200 mg (N = 6) | ARRY-382 300 mg (N = 6) | ARRY-382 400 mg (N = 7) | Total (N = 19) | PDA (N = 27) | PD-1/PD-L1 IR (N = 19) | prOVCA (N = 11) |
| Best overall response | |||||||
| CR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| PR | 1 (16.7) | 1 (16.7) | 0 (0.0) | 2 (10.5) | 1 (3.7) | 0 (0.0) | 0 (0.0) |
| SD | 3 (50.0) | 2 (33.3) | 0 (0.0) | 5 (26.3) | 5 (18.5) | 8 (42.1) | 4 (36.4) |
| PD | 1 (16.7) | 3 (50.0) | 5 (71.4) | 9 (47.4) | 7 (25.9) | 9 (47.4) | 5 (45.5) |
| NE | 1 (16.7) | 0 (0.0) | 2 (28.6) | 3 (15.8) | 14 (51.9) | 2 (10.5) | 2 (18.2) |
| ORR, % (95% CI) | 16.7 (0.4–64.1) | 16.7 (0.4–64.1) | 0.0 (0.0–41.0) | 10.5 (1.3–33.1) | 3.7 (0.1–19.0) | 0.0 (0.0–17.6) | 0.0 (0.0–28.5) |
| Immune-related best overall response | |||||||
| CR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| PR | 1 (16.7) | 1 (16.7) | 0 (0.0) | 2 (10.5) | 1 (3.7) | 0 (0.0) | 0 (0.0) |
| SD | 3 (50.0) | 3 (50.0) | 2 (28.6) | 8 (42.1) | 7 (25.9) | 7 (36.8) | 6 (54.5) |
| PD | 1 (16.7) | 0 (0.0) | 1 (14.3) | 2 (10.5) | 0 (0.0) | 1 (5.3) | 0 (0.0) |
| NE | 1 (16.7) | 2 (33.3) | 4 (57.1) | 7 (36.8) | 19 (70.4) | 11 (57.9) | 5 (45.5) |
| ir-ORR, % (95% CI) | 16.7 (0.4–64.1) | 16.7 (0.4–64.1) | 0.0 (0.0–41.0) | 10.5 (1.3–33.1) | 3.7 (0.1–19.0) | 0.0 (0.0–17.6) | 0.0 (0.0–28.5) |
Note: Full analysis set. Exact 2-sided 95% CI using the Clopper–Pearson method. Tumor assessment was based on investigator assessment. Confirmed best overall response was derived per visit-level overall response.
Abbreviations: CI, confidence interval; CR, complete response; ir, immune-related; IR, inhibitor refractory; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PDA, pancreatic ductal adenocarcinoma; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PR, partial response; prOVCA, platinum-resistant ovarian cancer; SD, stable disease.