Table 2.
Summary of objective response
| Epacadostat + pembrolizumab with chemotherapy (n = 91) | Placebo + pembrolizumab with chemotherapy (n = 87) | |||
|---|---|---|---|---|
| n | % (95% CI) | n | % (95% CI) | |
| CR | 0 | 0 (0.0–4.0) | 0 | 0 (0.0–4.2) |
| PR | 24 | 26.4 (17.7–36.7) | 39 | 44.8 (34.1–55.9) |
| Overall responsea | 24 | 26.4 (17.7–36.7) | 39 | 44.8 (34.1–55.9) |
| SDb | 38 | 41.8 (31.5–52.6) | 35 | 40.2 (29.9–51.3) |
| Disease controlc | 62 | 68.1 (57.5–77.5) | 74 | 85.1 (75.8–91.8) |
| PD | 14 | 15.4 (8.7–24.5) | 8 | 9.2 (4.1–17.3) |
| NEd | 7 | 7.7 (3.1–15.2) | 2 | 2.3 (0.3–8.1) |
| No assessmente | 8 | 8.8 (3.9–16.6) | 3 | 3.4 (0.7–9.7) |
| Patients with a responsef | 24 | 39 | ||
| TTR, median (range), months | 1.6 (1.2–6.1) | 1.4 (1.1–6.2) | ||
| DOR,g median (range), months | NR (1.1 + to 7.0 +) | 7.0 (1.2 + to 8.0 +) | ||
| Patients with ongoing response, n (%)h | 20 (83.3) | 29 (74.4) | ||
| ≥ 3 months | 14 (58.3) | 19 (48.7) | ||
| ≥ 6 months | 7 (29.2) | 6 (15.4) | ||
Responses based on BICR assessment per RECIST v1.1
BICR Blinded independent central review, CI Confidence interval, CR Complete response, DOR Duration of response, NE Not evaluable, NR Not reached, PD Progressive disease, PR Partial response, RECIST v1.1 Response Evaluation Criteria In Solid Tumors version 1.1, SD Stable disease, TTR time to response
aOverall response includes CR and PR
bSD includes both SD and Non-CR/Non-PD
cDisease control includes CR, PR and SD
dPost-baseline assessment(s) available but not evaluable or CR/PR/SD < 6 weeks from randomization
eNo post-baseline assessment available
fIncludes patients with best objective response as confirmed CR or PR
gFrom product-limit (Kaplan–Meier) method for censored data. " + " indicates there is no PD by the time of last disease assessment
hIncludes patients who are alive, have not progressed, have not initiated new anticancer treatment, are not lost to follow-up and whose last disease assessment was < 5 months prior to data cutoff date