Contributions
Abstract: PB1874
Type: Publication Only
Background
Idelalisib, a first-in-class PI3Kδ inhibitor, is indicated in combination with rituximab or ofatumumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies and as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Aims
To prospectively collect safety and efficacy data on idelalisib use in routine clinical practice in Germany.
Methods
A prospective, two-cohort, multicenter, non-interventional post authorization safety study (PASS); inclusion of patients is based on the physician’s decision to initiate treatment with idelalisib in accordance with the German Summary of Product Characteristics; primary objectives are progression-free survival, overall response rate and overall survival; secondary objectives include the incidence and severity of adverse drug reactions and fatal events; descriptive statistics are used for data analysis.
Results
The second pre-planned interim analysis includes results of 93 patients (83 patients with CLL, 10 patients with FL) in 49 active sites in Germany that had completed at least 3 months after initiation of idelalisib treatment. Patients with CLL had a median age of 74 years and were predominantly male (69%) while patients with FL had a median age of 66 years and were predominantly female (90%). Median time from diagnosis to start of idelalisib therapy was 93 (range 0.4 - 307.8) months for CLL and 37 (range 21.5 - 360.1) months for FL. 68% of patients had a Karnofsky index of ≥80 and 86% of patients presented with one or more co-morbidities. 35% (n=88) of documented co-morbidities (n=249) were diseases of the circulatory system according to ICD-10 classification. Among these the most frequently reported were hypertensive disease (n=41), cardiac arrhythmias (n=15) and chronic ischemic heart disease (n=10). In the CLL cohort deletion 17p and/or TP53 mutation was detected in 21%, deletion 11q in 19% and deletion 13q in 23% of patients. The median observation time was 6 months for the entire study population, 7 months for the CLL and 5 months for the FL cohort. By the time of data extract 63% of patients had permanently discontinued idelalisib treatment with a median time to permanent treatment discontinuation of 5 months. A total of 75 treatment interruptions were reported.
Conclusion
Post-authorization safety and efficacy data are important to assess the benefit/risk profile of therapies in routine clinical practice. Our prospective PASS on the use of idelalisib in Germany is therefore reporting safety and efficacy data on an ongoing basis.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia, Follicular lymphoma, PI3K, Safety
Abstract: PB1874
Type: Publication Only
Background
Idelalisib, a first-in-class PI3Kδ inhibitor, is indicated in combination with rituximab or ofatumumab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies and as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
Aims
To prospectively collect safety and efficacy data on idelalisib use in routine clinical practice in Germany.
Methods
A prospective, two-cohort, multicenter, non-interventional post authorization safety study (PASS); inclusion of patients is based on the physician’s decision to initiate treatment with idelalisib in accordance with the German Summary of Product Characteristics; primary objectives are progression-free survival, overall response rate and overall survival; secondary objectives include the incidence and severity of adverse drug reactions and fatal events; descriptive statistics are used for data analysis.
Results
The second pre-planned interim analysis includes results of 93 patients (83 patients with CLL, 10 patients with FL) in 49 active sites in Germany that had completed at least 3 months after initiation of idelalisib treatment. Patients with CLL had a median age of 74 years and were predominantly male (69%) while patients with FL had a median age of 66 years and were predominantly female (90%). Median time from diagnosis to start of idelalisib therapy was 93 (range 0.4 - 307.8) months for CLL and 37 (range 21.5 - 360.1) months for FL. 68% of patients had a Karnofsky index of ≥80 and 86% of patients presented with one or more co-morbidities. 35% (n=88) of documented co-morbidities (n=249) were diseases of the circulatory system according to ICD-10 classification. Among these the most frequently reported were hypertensive disease (n=41), cardiac arrhythmias (n=15) and chronic ischemic heart disease (n=10). In the CLL cohort deletion 17p and/or TP53 mutation was detected in 21%, deletion 11q in 19% and deletion 13q in 23% of patients. The median observation time was 6 months for the entire study population, 7 months for the CLL and 5 months for the FL cohort. By the time of data extract 63% of patients had permanently discontinued idelalisib treatment with a median time to permanent treatment discontinuation of 5 months. A total of 75 treatment interruptions were reported.
Conclusion
Post-authorization safety and efficacy data are important to assess the benefit/risk profile of therapies in routine clinical practice. Our prospective PASS on the use of idelalisib in Germany is therefore reporting safety and efficacy data on an ongoing basis.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia, Follicular lymphoma, PI3K, Safety