Table 5.
Best overall response with BMS-986148 ± nivolumab (CA008-002).
| BMS-986148 monotherapy | BMS-986148 + nivolumab | |||||
|---|---|---|---|---|---|---|
| All escalation | All expansion | Mesothelioma expansion | Ovarian expansion | All | Mesothelioma | |
| (n = 45) | (n = 51) | (n = 25) | (n = 22) | (n = 30)a | (n = 13)b | |
| ORR, n (%) | 1 (2)c | 3 (6)d | 1 (4) | 2 (9) | 6 (20) | 3 (23)e |
| [95% CI] | [1–12] | [1–16] | [0–20] | [1–29] | [8–39] | [5–54] |
| Best overall response, n (%) | ||||||
| CR | 0 | 0 | 0 | 0 | 0 | 0 |
| PR | 1 (2) | 3 (6) | 1 (4) | 2 (9) | 6 (20) | 3 (23) |
| SD | 10 (22) | 25 (49) | 13 (52) | 11 (50) | 14 (47) | 8 (62) |
| PD | 28 (62) | 16 (31) | 7 (28) | 7 (32) | 6 (20) | 1 (8) |
| Not evaluable | 6 (13) | 0 | 0 | 0 | 0 | 0 |
| Not reported | 0 | 7 (14) | 4 (16) | 2 (9) | 4 (13) | 1 (8) |
| DCR, n (%)f | 11 (24) | 28 (55) | 14 (56) | 13 (59) | 20 (67) | 11 (85) |
| PFS, median, mo (range) | NAh | 2.8 (0.0, 26.5+) | 3.8 (0.0+, 26.5+) | 2.8 (0.0+, 24.0+) | NAh | 6.5 (0.6, 19.4+) |
| [95% CI]g | [1.5–4.2] | [1.4–9.5] | [1.3–4.2] | [2.6–12.1] | ||
Abbreviations: +, censored; CR, complete response; DCR, disease control rate; NA, not available; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.
aIncludes patients from dose-escalation and dose-expansion cohorts.
bIncludes only patients from the expansion cohort. An additional three patients with mesothelioma were treated in the escalation cohort, with two reporting confirmed PRs lasting 9.69 and 10.41 months.
cOne patient with mesothelioma assigned to 0.8 mg/kg every 3 weeks had a confirmed PR lasting 10.22 months.
dOf four patients with NSCLC treated with monotherapy, none had a best overall response of CR or PR.
eThe mean ORR was 31% with the combination in the escalation and expansion cohorts with mesothelioma (n = 16).
fDCR was defined as CR, PR, or SD.
gBy Kaplan-Meier method.
hAggregate escalation PFS data are unavailable because of the confounding variables of different dose levels in different tumor types.