Table 2.
Summary of patient disposition for RP2D populationsa
|
RCC Cohort Ibrutinib 840 mg + Everolimus N = 39 |
GC Cohort Ibrutinib 560 mg + Docetaxel N = 46 |
CRC Cohort Ibrutinib 840 mg + Cetuximab N = 50 |
|
|---|---|---|---|
| Treatment duration, ibrutinib, median (range), months | 2.8 (0.1–27.9) | 2.5 (0.1–15.1) | 3.2 (0.2–14.0) |
| Treatment duration of partner drug, median (range), months | 3.1 (0.1–27.9) | 2.1 (0.0–14.5) | 3.0 (0.0–13.8) |
| Ibrutinib treatment disposition, n (%) | |||
| Still on treatment | 0 | 0 | 0 |
| Discontinued treatment | 39 (100) | 46 (100) | 50 (100) |
| Primary reason for ibrutinib discontinuation, n (%) | |||
| Disease progression | 22 (56) | 29 (63) | 35 (70) |
| Clinical deterioration | 2 (5) | 3 (7) | 1 (2) |
| Adverse events | 12 (31) | 8 (17) | 8 (16) |
| Death | 0 | 0 | 1 (2) |
| Withdrawal of consent | 2 (5) | 4 (9) | 4 (8) |
| Investigator decision | 1 (3) | 2 (4) | 1 (2) |
| Companion drug treatment disposition, n (%) | |||
| Still on treatment | 0 | 0 | 0 |
| Discontinued treatment | 39 (100) | 46 (100) | 50 (100) |
| Primary reason for discontinuation of companion drug, n (%) | |||
| Disease progression | 22 (56) | 26 (57) | 32 (64) |
| Clinical deterioration | 2 (5) | 2 (4) | 1 (2) |
| Adverse events | 11 (28) | 10 (22) | 10 (20) |
| Death | 0 | 0 | 1 (2) |
| Withdrawal of consent | 3 (8) | 4 (9) | 4 (8) |
| Investigator decision | 1 (3) | 4 (9) | 2 (4) |
CRC colorectal adenocarcinoma, ECOG Eastern Cooperative Oncology Group, GC gastric adenocarcinoma, RCC renal cell carcinoma, RP2D Recommended phase 2 dose
aData cutoff date: 19 April 2021