TABLE 1.
Patient demographics and baseline characteristics of patients with CLL
| Relapsed/refractory | Treatment-naïve | |||
|---|---|---|---|---|
| Demographics and baseline characteristics | 25 mg BID n = 28 | 75 mg BID n = 24 | All doses n = 55 | 25 mg BID n = 18 |
| Demographics | ||||
| Age (years), median (range) | 66 (42–82) | 66 (51–79) | 66 (42–82) | 74 (49–83) |
| Race, white, n (%) | 24 (85.7) | 22 (91.7) | 49 (89.1) | 18 (100) |
| Sex, male, n (%) | 25 (89.3) | 15 (62.5) | 42 (76.4) | 13 (72.2) |
| Baseline disease status | ||||
| Diagnosis, n (%) | ||||
| CLL | 24 (85.7) | 23 (95.8) | 50 (90.9) | 18 (100) |
| SLL | 4 (14.3) | 1 (4.2) | 5 (9.1) | NA |
| Years from initial diagnosis, median (range) | 9.25 (1.4–20.9) | 7.15 (0.7–17.8) | 8.50 (0.7–20.9) | 2.90 (0.1–9.4) |
| Baseline disease istage 3, n (%) | 23 (85.2)a | 17 (70.1) | 42 (77.8) | 6 (33) |
| Bulky disease (>5 cm lesion) | 13 (46.4) | 13 (65.0)b | 26 (50.9)b | 5(29) |
| Splenomegaly, n (%) | 6 (21.4) | 6 (25.0) | 14 (25.5) | 8 (44.4) |
| ECOG score, 0/1/2, % | 28.6/64.3/7.1 | 16.7/79.2/4.2 | 23.6/70.9/5.5 | 44.4/55.6/0 |
| Cytopenias at baseline | ||||
| Grade 3, n (%) | 8 (28.6) | 5 (20.8) | 13 (23.6) | 2 (11.1) |
| Grade 4, n (%) | 3 (10.7) | 5 (20.8) | 8 (14.5) | 2 (11.1) |
| Previous anticancer therapies | ||||
| No. prior systemic therapies, median (range) | 5.0(1–11) | 4.0 (1–11) | 4.0 (1–11) | NA |
| <6 mo. from last systemic therapy, n (%) | 16 (57.1) | 19 (79.2) | 35 (63.6) | NA |
| Alkylating agent, n (%) | 27 (96.4) | 23 (95.8) | 53 (96.4) | NA |
| Rituximab, n (%) | 27 (96.4) | 23 (95.8) | 52 (94.5) | NA |
| Purine analog, n (%) | 20 (71.4) | 22 (91.7) | 43 (78.2) | NA |
| Anthracycline, n (%) | 7 (25.0) | 3 (12.5) | 12 (21.8) | NA |
| BTKi, n (%) | 2 (7.1) | 4 (16.7) | 6 (10.9) | NA |
| High-risk mutation status | ||||
| TP53 mutation/17p-deletion, n (%)c | 14 (53.8) | 14 (58.3) | 28 (56.0) | 10 (55.5) |
| Unmutated IGHVd | 21 (84.0) | 14 (87.5) | 38 (86.4) | 14 (82.4) |
| Del11q, n (%)e | 6 (31.6) | 8 (57.14) | 14 (40.0) | 6 (37.5) |
Abbreviations: BID, twice daily; BTKi, Bruton’s tyrosine kinase inhibitor; CLL, chronic lymphocytic leukemia; ECOG, Eastern Cooperative Oncology Group; IGHV, immunoglobulin heavy chain variable; NA, not applicable; RR, relapsed/refractory; SLL, small lymphocytic lymphoma; TN, treatment-naïve.
Baseline disease stage not reported for 1 patient on duvelisib 25 mg BID; the incidence is based upon patients with available data.
Bulky disease information at baseline not reported for 4 patients at 75 mg BID, and 4 patients across all doses for RR; the incidence is based upon patients with available data.
Baseline mutation status not reported for 2 patients at 25 mg BID, 3 patients at 75 mg BID, and 5 patients across all doses for RR. For TN, 1 patient had no mutation status reported at baseline. The incidence is based upon patients with available data.
Baseline IGHV mutation status was not available for 3 patients at 25 mg BID, 8 patients at 75 mg BID, and 11 patients across all doses for RR-CLL/SLL, nor for 1 patient with TN-CLL. The incidence is based upon patients with available data
Baseline mutation status was not available for 9 patients at 25 mg BID, 10 patients at 75 mg BID, and 20 patients across all doses for RR-CLL/SLL, nor for 2 patients with TN-CLL. The incidence is based upon patients with available data.