MANAGEMENT, ADVERSE EVENTS, AND OUTCOMES OF 282 CLL PATIENTS (PTS) TREATED WITH VENETOCLAX (VEN) IN THE REAL WORLD
Author(s): ,
Chadi Nabhan
Affiliations:
Cardinal Health,Dublin,United States
,
Andrew Klink
Affiliations:
Cardinal Health,Dallas,United States
,
Jennifer Samp
Affiliations:
AbbVie,Chicago,United States
,
James Pauff
Affiliations:
AbbVie,Chicago,United States
,
Jacqueline Nielsen
Affiliations:
AbbVie,Chicago,United States
,
Brian Meissner
Affiliations:
AbbVie,Chicago,United States
,
Holger Keim
Affiliations:
AbbVie,Chicago,United States
,
Kaitlin Kennard
Affiliations:
Hematology and Oncology,University of Pennsylvania,Philadelphia,United States
Anthony Mato
Affiliations:
Memorial Sloan Kettering Cancer Center,New York,United States
EHA Library. Nabhan C. Jun 15, 2018; 214816; PF342
Chadi Nabhan
Chadi Nabhan
Contributions
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Abstract

Abstract: PF342

Type: Poster Presentation

Presentation during EHA23: On Friday, June 15, 2018 from 17:30 - 19:00

Location: Poster area

Background
Ven is an oral bioavailable BCL-2 inhibitor with demonstrated activity in clinical trials for relapse/refractory (R/R) CLL pts including those with del17p or failing a kinase inhibitor (KI). Ven was initially approved in the US and EU in 2016. As expanded indications for Ven in CLL are under investigation, additional data are needed to understand use and outcomes in clinical practice. 

Aims
Describe initiation, management and outcomes of Ven-treated CLL pts in the real world.

Methods
This is a retrospective cohort study of CLL pts initiating Ven. Investigators from 33 community centers provided pt-level data from medical records including demographics, clinical characteristics, ramp up management and outcomes. Tumor burden was assessed per FDA label, tumor lysis syndrome (TLS) was defined by Howard criteria and response was based on iwCLL criteria. The primary endpoints were progression free survival (PFS) and overall survival (OS). The secondary endpoint was overall response rate (ORR: complete or partial response [CR or PR]). Characteristics and outcomes were summarized by descriptive statistics, and comparisons of ORR by subgroups were assessed on univariate analyses.  

Results
282 Ven pts were included, of whom 22% used Ven in combination with ibrutinib (7%) or an anti-CD20 (15%). Median age was 67 years (range 60-73); 83% had TP53 interruption; 64% had 1 prior therapy and 23% had ≥2 prior therapies (median 1; range 0-6); 61% and 3% had prior use of 1 and 2 KIs, respectively. At baseline, 12%, 54% and 34% had low, medium and high tumor burden, respectively; 32% initiated Ven as inpatient. During ramp up, 9% had a dose interruption; 4 of 6 dose reductions were due to TLS or hematologic abnormalities. TLS events occurred in 8% of pts (n=22) with 5 pts experiencing clinical TLS. With a median follow up of 5.8 months, ORR was 82% (CR: 29%). Responses were not negatively affected by pt, disease or treatment factors that were assessed with the exception of TP53 status (Table; response not assessed in 27(9.6%) pts). The 12-month PFS and OS were 83% and 91%, respectively (Figure). Among 48 pts assessed for minimal residual disease (MRD) during Ven treatment, 27 (63%) were MRD negative. Resolution of baseline lymphadenopathy, lymphocytosis, or B symptoms were reported in 94%, 95% and 95%, respectively. Among 48 pts (17%) who discontinued Ven, median time to discontinuation was 6.1 months. Discontinuation was mainly due to response to therapy (n=12), refractoriness (n=11), pt request (n=10) or relapse (n=5). 

 

All Ven pts

Age

Prior lines

TP53 interruption

Prior KI use

Lymph node size

TLS during ramp-up

Max Ven dose

<65 years

≥65 years

0

1

≥2

Present

Absent

Yes

No

All LN <5cm

Any LN ≥5cm

Yes

No

400mg

<400mg

ORR, n (%)

208 (82%)

76 (83%)

132 (81%)

32 (91%)

130 (80%)

46 (81%)

176 (84%)

32 (70%)

117 (82%)

91 (81%)

95 (80%)

103 (83%)

16 (80%)

192 (82%)

108 (81%)

100 (83%)

CR, n (%)

73 (29%)

30 (33%)

43 (26%)

13 (37%)

44 (27%)

16 (28%)

61 (29%)

12 (26%)

38 (27%)

35 (31%)

28 (24%)

45 (36%)

8 (40%)

65 (28%)

41 (31%)

32 (26%)

ORR across subgroups, p-value

-

0.87

0.28

0.03

0.75

0.62

0.77

0.75

 

Conclusion
In the largest study of Ven-treated CLL pts in community practice, PFS, OS and response rates were comparable to clinical trials with most clinical factors not impacting response to therapy. Ven was well tolerated and few experienced a TLS/ hematologic event. Taken together, these results support the generalizability of Ven use in community settings. Further analyses on ramp up management and outcomes will be presented.

Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical

Keyword(s): Chronic Lymphocytic Leukemia, Outcome measurement, Treatment

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