Table 1.
Demographics and baseline characteristics.
| Pembrolizumab monotherapy (n = 39)a | Pembrolizumab plus acalabrutinib (n = 37) | Total (N = 76) | |
|---|---|---|---|
| Age, median (range), y | 61.0 (38.0–83.0) | 58.0 (45.0–97.0) | 60.5 (38.0–97.0) |
| Sex, male, n (%) | 34 (87.2) | 35 (94.6) | 69 (90.8) |
| Race, n (%) | |||
| Asian | 2 (5.1) | 2 (5.4) | 4 (5.3) |
| Black or African American | 0 | 6 (16.2) | 6 (7.9) |
| White | 37 (94.9) | 29 (78.4) | 66 (86.8) |
| ECOG PS, n (%) | |||
| 0 | 9 (23.1) | 9 (24.3) | 18 (23.7) |
| 1 | 30 (76.9) | 28 (75.7) | 58 (76.3) |
| Disease stage, n (%) | |||
| Stage Ib | 0 | 1 (2.7) | 1 (1.3) |
| Stage IIc | 0 | 1 (2.7) | 1 (1.3) |
| Stage IIId | 0 | 1 (2.7) | 1 (1.3) |
| Stage IVAe | 13 (33.3) | 11 (29.7) | 24 (31.6) |
| Stage IVBf | 2 (5.1) | 1 (2.7) | 3 (3.9) |
| Stage IVCg | 24 (61.5) | 22 (59.5) | 46 (60.5) |
| Number of prior systemic regimensh, median (range) | 2 (1–5) | 2 (1–7) | 2 (1–7) |
| Number of prior systemic regimens, n (%) | |||
| 1 | 9 (23.1) | 8 (21.6) | 17 (22.4) |
| 2 | 14 (35.9) | 13 (35.1) | 27 (35.5) |
| ≥3 | 16 (41.0) | 16 (43.2) | 32 (42.1) |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; M, metastasis; N, node; T, tumor.
aAEs experienced up to crossover date are summarized under pembrolizumab arm.
bDefined as T1, N0, M0.
cDefined as T2, N0, M0.
dDefined as either (i) T3, N0–N2, M0, or (ii) T1/T2, N2, M0.
eDefined as either (i) T1–T3, N2, M0; (ii) T4A, N0–N2, M0; (iii) T4, N0–N2, M0; (iv) T4A, N0/N1, M0; or (v) T1–T4A, N2, M0.
fDefined as either (i) Any T, N3, M0; (ii) T4B, any N, M0; (iii) T4B, any N, M0; or (iv) any T, N3, M0.
gDefined as any T, any N, M1.
hPrior definitive or adjuvant therapy.