Abstract 840P
Background
Targeted therapy with Bruton's tyrosine kinase inhibitors (BTKis) become the standard of care for chronic lymphocytic leukemia (CLL). Orelabrutinib (O) is a novel BTKi with high selectivity and a favorable safety profile. Despite substantial benefits in CLL with O, real-world data remains scarce. This study aimed to evaluate the efficacy of O-based regimens for CLL with comorbidities in a real-world setting.
Methods
Data were retrospectively reviewed for 15 pts with CLL who underwent O-based regimens from Jun. 10, 2022, to Sep. 10, 2023. The outcome was the hematologic response (HR) rate, defined as the proportion of pts with abnormal baseline hematologic parameters who had a hemoglobin (Hb) response, platelet (Plt) response, or lymphocyte (Lym) response (Hb/Plt/Lym count return to or reduce >50% from baseline).
Results
Baseline characteristics of the pts are presented in the table. The median duration of O therapy was 10.7 months (interquartile range [IQR], 8.6-14.9). At the data cut-off (Apr. 26, 2024; median follow-up, 12.7 months), 14 (93.3%) pts achieved an HR. The remaining 1 pt that did not reach HR was a third-line treatment pt with HBV infection, and there was some recovery of hematologic indexes. Regarding different O-based regimens, HR was achieved in 100% (8/8) of pts receiving O monotherapy and 85.7% (6/7) receiving O + chemotherapy. No serious adverse events occurred in the pts with comorbidities. Table: 840P
Baseline characteristics
Characteristics | All (n=15) |
Sex (n, %) | |
Male | 11 (73.3) |
Female | 4 (26.7) |
Median age, years (IQR) | 62.0 (59.0-66.5) |
Rai stage (n, %) | |
I | 4 (26.7) |
II | 6 (40.0) |
III/IV | 5 (33.3) |
Binet stage (n, %) | |
A | 2 (13.3) |
B | 7 (46.7) |
C | 6 (40.0) |
Previous number of prior therapies (n, %) | |
0 | 13 (86.7) |
1 | 1 (6.7) |
2 | 1 (6.7) |
CLL-IPI score (n, %) | |
2-3 | 1 (6.7) |
4-6 | 2 (13.3) |
Unknown | 12 (80.0) |
IGHV status (n, %) | |
Mutated | 4 (26.7) |
Unmutated | 2 (13.3) |
Unknown | 9 (60.0) |
Comorbidity (n, %) | 12 (80.0) |
Respiratory infection | 3 (20.0) |
HBV/EBV infection | 4 (26.7) |
Cardiovascular/cerebrovascular disease | 5 (33.3) |
Endocrine disease | 4 (26.7) |
Unknown | 3 (20.0) |
Regimens (n, %) | |
O | 8 (53.3%) |
O + chemotherapy | 7 (46.7%) |
Conclusions
O-based regimens demonstrated encouraging HR and were well tolerated in CLL with comorbidities, providing valuable insights for clinical management.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
X. Lai.
Funding
National Natural Science Foundation of China (NO.8216010239).
Disclosure
All authors have declared no conflicts of interest.
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