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.
a
AEs experienced up to crossover date are summarized under pembrolizumab arm.
b
Defined as T1, N0, M0.
c
Defined as T2, N0, M0.
d
Defined as either (i) T3, N0-N2, M0, or (ii) T1/T2, N2, M0.
e
Defined 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.
f
Defined as either (i) Any T, N3, M0; (ii) T4B, any N, M0; (iii) T4B, any N, M0; or (iv) any T, N3, M0.
g
Defined as any T, any N, M1.
h
Prior definitive or adjuvant therapy.