EHA Library - The official digital education library of European Hematology Association (EHA)

REAL WORLD OUTCOME WITH IBRUTINIB IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA FROM THE GERMAN REALITY STUDY
Author(s): ,
Manfred Welslau
Affiliations:
Oncology and Hematology,MVZ at Medical Clinic Aschaffenburg-Alzenau,Aschaffenburg,Allemagne;Oncology and Hematology,MVZ at Medical Clinic Aschaffenburg-Alzenau,Aschaffenburg,Deutschland;Oncology and Hematology,MVZ at Medical Clinic Aschaffenburg-Alzenau,Aschaffenburg,Germania;Oncology and Hematology,MVZ at Medical Clinic Aschaffenburg-Alzenau,Aschaffenburg,Germany;Oncology and Hematology,MVZ at Me
,
Rudolf Schlag
Affiliations:
Oncology and Hematology,Oncological Practice,Würzburg,Allemagne;Oncology and Hematology,Oncological Practice,Würzburg,Deutschland;Oncology and Hematology,Oncological Practice,Würzburg,Germania;Oncology and Hematology,Oncological Practice,Würzburg,Germany;Oncology and Hematology,Oncological Practice,Würzburg,Alemania;Oncology and Hematology,Oncological Practice,Würzburg,Duitsland;Oncology and Hemat
,
Bernhard Heinrich
Affiliations:
Oncology and Hematology,Oncological Practice,Augsburg,Allemagne;Oncology and Hematology,Oncological Practice,Augsburg,Deutschland;Oncology and Hematology,Oncological Practice,Augsburg,Germania;Oncology and Hematology,Oncological Practice,Augsburg,Germany;Oncology and Hematology,Oncological Practice,Augsburg,Alemania;Oncology and Hematology,Oncological Practice,Augsburg,Duitsland;Oncology and Hemat
,
Lukas Vornholz
Affiliations:
Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Allemagne;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Deutschland;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germania;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germany;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Alemania;Medical & Scientific Affairs,Janss
,
Sabrina Buchholz
Affiliations:
Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Allemagne;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Deutschland;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germania;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germany;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Alemania;Medical & Scientific Affairs,Janss
,
Barbara Marquard
Affiliations:
Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Allemagne;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Deutschland;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germania;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Germany;Medical & Scientific Affairs,Janssen-Cilag GmbH,Neuss,Alemania;Medical & Scientific Affairs,Janss
,
Steffen Dörfel
Affiliations:
Oncology and Hematology,Onco Center Dresden,Dresden,Allemagne;Oncology and Hematology,Onco Center Dresden,Dresden,Deutschland;Oncology and Hematology,Onco Center Dresden,Dresden,Germania;Oncology and Hematology,Onco Center Dresden,Dresden,Germany;Oncology and Hematology,Onco Center Dresden,Dresden,Alemania;Oncology and Hematology,Onco Center Dresden,Dresden,Duitsland;Oncology and Hematology,Onco C
Gerhardt Anke
Affiliations:
Hematological and Oncological Diseases,MVZ Potsdam,Potsdam,Allemagne;Hematological and Oncological Diseases,MVZ Potsdam,Potsdam,Deutschland;Hematological and Oncological Diseases,MVZ Potsdam,Potsdam,Germania;Hematological and Oncological Diseases,MVZ Potsdam,Potsdam,Germany;Hematological and Oncological Diseases,MVZ Potsdam,Potsdam,Alemania;Hematological and Oncological Diseases,MVZ Potsdam,Potsda
(Abstract release date: 05/12/22) EHA Library. Welslau M. 06/10/22; 357498; P636
Manfred Welslau
Manfred Welslau
Contributions
Abstract
Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P636

Type: Poster presentation

Session title: Chronic lymphocytic leukemia and related disorders - Clinical

Background

Chronic lymphocytic leukemia (CLL) is one of the most common forms of leukemia, characterized by abnormal survival and proliferation of mature B cells in peripheral blood, bone marrow, and lymph nodes. Ibrutinib is a once-daily Bruton’s tyrosine kinase inhibitor (BTKi) with a significant benefit in both progression free survival (PFS) and overall survival (OS) demonstrated in multiple phase 3 trials for patients (pts) with previously untreated (1L) or relapsed/refractory (R/R) CLL. In 2014, ibrutinib was approved by the European Medicines Agency and made available to CLL pts in Germany. Prior to the REALITY study, limited data were available on the effectiveness of ibrutinib-treated pts with CLL in routine clinical practice in Germany.

Aims

REALITY was a prospective, multicenter, non-interventional study to evaluate the effectiveness of ibrutinib as the 1st, 2nd, or ≥3rd line of treatment (cohorts C1, C2, and C3 respectively) in pts with CLL during the first 2 years of observation period in a real-world setting.

Methods

302 pts were enrolled in the three cohorts (C1: 104 pts; C2: 90 pts; C3: 108 pts) and treated in 57 study sites in Germany from January 2017 to July 2021. Written informed consent was obtained from all pts. Key study endpoints include retention rate (defined as ratio of pts on ibrutinib treatment to the number of pts at risk), start of next therapy, PFS, OS, and safety. The results of this study are descriptive, and no formal hypotheses was pre-specified.

Results

Median age at time of ibrutinib treatment initiation was 74.0 years for the 1L pts in C1, and 72.5 and 73.0 years in the R/R cohorts of C2 and C3, respectively.

In cohort C1 (1L), pts with genetic high risk features del(17p) and TP53 mutation were more frequent compared to C2 and C3. In C1 del(17p) was reported in 34/51 (66.7%) pts and TP53 mutations in 31/49 (63.3%) pts. In the R/R cohorts C2 and C3 del(17p) was reported in 11/57 (19.3%) pts and 13/65 (20.0%) pts, respectively. TP53 mutations were reported in 14/48 (29.2%) pts in C2 and 21/40 (52.5%) pts in C3.

The primary study endpoint was retention rate, 77.9% pts continued to be on treatment after 1 year in C1 (1L). In C2 and C3 (R/R), the 1-year retention rates were 74.4% and 58.3% respectively.

In C1, with median follow-up of 30.6 months, median PFS was not reached (NR). The 1-year PFS and OS in the C1 cohort (1L) were 91.3% and 96.2%, respectively. Only 8 pts initiated next line treatment in C1 after 1 year.

In C2, with a median follow-up of 31.5 months, median PFS was NR. The 1-year PFS and OS were 85.6% and 93.3%, respectively. 11 pts initiated next line treatment in C2 after 1 year.

In C3 median follow-up was 30.9 months and median PFS was NR. The 1-year PFS and OS were 83.3% and 93.5%, respectively. 26 pts initiated next line treatment in C3 after 1 year.

Detailed results after 1 and 2 years of observation are summarized in Table 1.

No new safety signals for ibrutinib were observed.

Conclusion
This first, comprehensive data from clinical practice of ibrutinib-treated pts with CLL in Germany showed that ibrutinib is a highly effective treatment option, especially as a 1st line treatment. The effectiveness and safety profile were consistent with clinical trials.

Keyword(s): Chronic lymphocytic leukemia, Clinical trial, Ibrutinib

Presentation during EHA2022: All (e)Poster presentations will be made available as of Friday, June 10, 2022 (09:00 CEST) and will be accessible for on-demand viewing until Monday, August 15, 2022 on the Congress platform.

Abstract: P636

Type: Poster presentation

Session title: Chronic lymphocytic leukemia and related disorders - Clinical

Background

Chronic lymphocytic leukemia (CLL) is one of the most common forms of leukemia, characterized by abnormal survival and proliferation of mature B cells in peripheral blood, bone marrow, and lymph nodes. Ibrutinib is a once-daily Bruton’s tyrosine kinase inhibitor (BTKi) with a significant benefit in both progression free survival (PFS) and overall survival (OS) demonstrated in multiple phase 3 trials for patients (pts) with previously untreated (1L) or relapsed/refractory (R/R) CLL. In 2014, ibrutinib was approved by the European Medicines Agency and made available to CLL pts in Germany. Prior to the REALITY study, limited data were available on the effectiveness of ibrutinib-treated pts with CLL in routine clinical practice in Germany.

Aims

REALITY was a prospective, multicenter, non-interventional study to evaluate the effectiveness of ibrutinib as the 1st, 2nd, or ≥3rd line of treatment (cohorts C1, C2, and C3 respectively) in pts with CLL during the first 2 years of observation period in a real-world setting.

Methods

302 pts were enrolled in the three cohorts (C1: 104 pts; C2: 90 pts; C3: 108 pts) and treated in 57 study sites in Germany from January 2017 to July 2021. Written informed consent was obtained from all pts. Key study endpoints include retention rate (defined as ratio of pts on ibrutinib treatment to the number of pts at risk), start of next therapy, PFS, OS, and safety. The results of this study are descriptive, and no formal hypotheses was pre-specified.

Results

Median age at time of ibrutinib treatment initiation was 74.0 years for the 1L pts in C1, and 72.5 and 73.0 years in the R/R cohorts of C2 and C3, respectively.

In cohort C1 (1L), pts with genetic high risk features del(17p) and TP53 mutation were more frequent compared to C2 and C3. In C1 del(17p) was reported in 34/51 (66.7%) pts and TP53 mutations in 31/49 (63.3%) pts. In the R/R cohorts C2 and C3 del(17p) was reported in 11/57 (19.3%) pts and 13/65 (20.0%) pts, respectively. TP53 mutations were reported in 14/48 (29.2%) pts in C2 and 21/40 (52.5%) pts in C3.

The primary study endpoint was retention rate, 77.9% pts continued to be on treatment after 1 year in C1 (1L). In C2 and C3 (R/R), the 1-year retention rates were 74.4% and 58.3% respectively.

In C1, with median follow-up of 30.6 months, median PFS was not reached (NR). The 1-year PFS and OS in the C1 cohort (1L) were 91.3% and 96.2%, respectively. Only 8 pts initiated next line treatment in C1 after 1 year.

In C2, with a median follow-up of 31.5 months, median PFS was NR. The 1-year PFS and OS were 85.6% and 93.3%, respectively. 11 pts initiated next line treatment in C2 after 1 year.

In C3 median follow-up was 30.9 months and median PFS was NR. The 1-year PFS and OS were 83.3% and 93.5%, respectively. 26 pts initiated next line treatment in C3 after 1 year.

Detailed results after 1 and 2 years of observation are summarized in Table 1.

No new safety signals for ibrutinib were observed.

Conclusion
This first, comprehensive data from clinical practice of ibrutinib-treated pts with CLL in Germany showed that ibrutinib is a highly effective treatment option, especially as a 1st line treatment. The effectiveness and safety profile were consistent with clinical trials.

Keyword(s): Chronic lymphocytic leukemia, Clinical trial, Ibrutinib

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies