Study design
The PCYC-1102/1103 study was a phase Ib/II, open-label, non-randomised study of single-agent IMBRUVICA® in firstline (≥65 years old) and R/R (≥1 prior therapies, ≥18 years old) CLL patients.[1]
Median age[1]
Firstline patients
71 years
(65-84)
R/R patients
64 years
(37-82)
Median number of therapies[1]
4 prior therapies for R/R patients
The PCYC-1102/1103 study included patients with high-risk features[1]
High-risk features included del(17p), del(11q), and/or unmutated IGHV
Baseline characteristics[1]
Characteristic | First-line ≥ 65 years | Relapsed/refractory |
| Median age (range), years ≥70 years, n (%) | 71 (65–84) 23 (74) | 64 (37–82) 34 (34) |
| Male, n (%) | 19 (61) | 79 (78) |
| ECOG PS, n (%) 0 1 2 | 23 (74) 8 (26) 0 | 43 (43) 54 (53) 4 (4) |
| Bulky disease ≥5 cm, n (%) | 6 (19) | 55 (54) |
| Baseline Rai stage III–IV, n (%) | 17 (55) | 58 (57) |
| Cytogenetics* n (%) Del(17p) Del(11q) Trisomy 12 Del(13q) No abnormality detected | 2 (6) 1 (3) 8 (26) 13 (42) 6 (19) | 34 (34) 28 (28) 5 (5) 13 (13) 16 (16) |
| β-2 microglobulin level >3 mg/L, n (%) | 8 (26) | 49 (49) |
Unmutated IGHV, n (%) | 15 (48) | 79 (78) |
Complex karyotype†, n (%) | 4 (13) | 37 (37) |
| Complex karyotype with del(17p), n (%) | 0 | 22 (22) |
| Complex karyotype without del(17p), n (%) | 4 (13) | 15 (15) |
| ANC ≤1.5 x 109/L | 1 (3) | 34 (34) |
| Haemoglobin ≤11 g/dL, n (%) | 11 (35) | 42 (42) |
| Platelets ≤100 x 109/L, n (%) | 12 (39) | 49 (49) |
| Median prior therapy, n (range) | -- | 4 (1–12) |
| Number of prior therapies, n (%) 1–2 3 ≥4 | -- -- -- | 27 (27) 14 (14) 60 (59) |
IMBRUVICA®
420 or 840 mg/day in 28-day cycles
until disease progression or unacceptable toxicity (n=132, firstline [n=31], R/R [n=101])[1]
Primary endpoint
AEs(frequency, severity, and relatedness)[1]
AEs were monitored from the first dose of IMBRUVICA® until 30 days after the last dose, and grading was according to the NCI Common Terminology Criteria for Adverse Events v4.0. All-grade AEs were collected in PCYC-1102.
PCYC-1103 Extension study
After the primary analysis, patients who completed ≥6 treatment cycles without disease progression could participate in the PCYC-1103 open-label extension study.[1]
Dosing:
Patients continued IMBRUVICA® at the same dose they received in PCYC-1102.[1]
Primary endpoint:
In PCYC-1103, grade ≥3 AEs, grade ≥2 eye-related AEs, or any grade serious AEs, AEs leading to dose reduction, AEs leading to treatment discontinuation, other malignancies, and major haemorrhage were collected.[1]
85.0 months extended median follow-up[1]
CLL patient subgroups
uIGHV patients
Genetic aberration patients
Fit patients
Relapsed / refractory patients
Back to IMBRUVICA® studies
*FISH cytogenetic subgroups are presented in a hierarchy of CLL chromosomal abnormalities based on Döhner classification. A total of 1 patient receiving firstline IMBRUVICA® and 5 patients receiving IMBRUVICA® for R/R CLL/SLL had missing FISH cytogenetic data.[^1]
†Complex karyotype was performed at a central laboratory and was defined as ≥3 unrelated chromosomal abnormalities by CpG stimulated metaphase cytogenetics.[^1]
AE=adverse event; ANC=absolute neutrophil count; CLL=chronic lymphocytic leukaemia; ECOG PS=Eastern Cooperative Oncology Group Performance Status; FISH=fluorescence in situ hybridisation; IGHV=immunoglobulin heavy-chain variable region; NCI=National Cancer Institute; R/R=relapsed/refractory; SLL=small lymphocytic lymphoma; uIGHV=unmutated immunoglobulin heavy-chain variable region.
