Table 3.
Tumor response by RECIST (efficacy evaluable population)
| Variable | Group A: itacitinib+epacadostat | Group B: itacitinib+parsaclisib | |||
| Part 1a Dose-escalation Group A (n=12) |
Part 1b Dose-expansion Groups A-1 and A-2 (n=35) |
Part 1a Dose-escalation Group B (n=42) |
Part 1b Dose-expansion Groups B-1 and B-2 (n=23) |
Part 2 Dose-expansion Groups B-3, B-4, and B-5 (n=30) |
|
| Best overall response, n (%) | |||||
| CR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| PR | 0 (0) | 0 (0) | 3 (7.1)* | 0 (0) | 0 (0) |
| SD | 4 (33.3) | 9 (25.7) | 11 (26.2) | 5 (21.7) | 10 (33.3) |
| PD | 6 (50.0) | 20 (57.1) | 22 (52.4) | 14 (60.9) | 16 (53.3) |
| NE | 0 (0) | 0 (0) | 0 (0) | 1 (4.3) | 1 (3.3) |
| NA† | 2 (16.7) | 6 (17.1) | 6 (14.3) | 3 (13.0) | 3 (10.0) |
| ORR‡, n (%) | 0 (0) | 0 (0) | 3 (7.1) | 0 (0) | 0 (0) |
| 95% CI for ORR§ | 0 to 26.46 | 0 to 10.00 | 1.50 to 19.48 | 0 to 14.82 | 0 to 11.57 |
*Tumor types of patients with PR were salivary gland cancer, HNSCC (nasopharynx), and other carcinoma.
† ‘NA’ includes any patients who did not have valid postbaseline overall response.
‡Patients who had best overall response of CR or PR.
§CI was calculated based on the exact method for binomial distributions.
CR, complete response; HNSCC, head and neck squamous cell carcinoma; NA, not assessed; NE, not estimable; ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.