Durable Responses With Single-agent Ibrutinib in CLL/SLL
A study suggests that single-agent ibrutinib results in durable responses among patients with CLL or SLL.
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Single-agent ibrutinib resulted in durable responses among patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), according to a poster presented at the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference.1
Preliminary data from a phase 1b/2 study and its extension trial suggested that single-agent ibrutinib is effective among patients with CLL/SLL. The purpose of this analysis was to determine the long-term efficacy and safety of ibrutinib.
The analysis combined data from the PCYC-1102 (ClinicalTrials.gov Identifier: NCT01105247) study and its extension, PCYC-1103 (ClinicalTrials.gov Identifier: NCT01109069). Thirty-one patients were treatment-naïve and 101 had relapsed/refractory disease. The majority of patients received the study treatment for at least 4 years, and 65% and 30% of patients in the treatment-naïve and relapsed/refractory cohorts, respectively, remained on ibrutinib.
Complete response was achieved by 29% of treatment-naïve patients and 10% of relapsed/refractory patients.
The 5-year progression-free survival (PFS) was 92% among treatment-naïve patients, with median PFS not reached. Patients with relapsed/refractory disease had a 5-year PFS of 43% with a median of 52 months, and 5-year overall survival (OS) of 57%.
PFS and OS were lower among patients with wild-type IGHV, deletion 17p or 11q, and complex karyotype. A 17p deletion was significantly associated with PFS and OS in a multivariate analysis.
Common grade 3-4 adverse events (AEs) included hypertension, pneumonia, neutropenia, and atrial fibrillation. The incidence of pneumonia, neutropenia, diarrhea, and fatigue decreased during the study, though the incidence of hypertension and atrial fibrillation remained the same. Most grade 3-4 AEs occurred during the first year of ibrutinib treatment.
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This study suggests that single-agent ibrutinib results in durable responses among treatment-naïve patients and those with relapse/refractory disease, and its safety profile enables long-term dosing even among elderly patients.
Read more of Cancer Therapy Advisor's coverage of the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference by visiting the conference page.
- O'Brien S, Furman RR, Coutre S, et al. Single-agent ibrutinib in treatment-naïve (TN) and relapsed/refractory (r/r) chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL): 4 years of experience. Poster presented at: 13th Hematology/Oncology Pharmacy Association Annual Conference; March 29-April 1, 2017; Anaheim, CA.