DURABILITY OF RESPONSE TO VENETOCLAX (VEN) IN PATIENTS WITH CLL RELAPSED/REFRACTORY TO IBRUTINIB AND/OR IDELALISIB
Author(s): ,
John C. Byrd
Affiliations:
The Ohio State University,Columbus,United States
,
William G. Wierda
Affiliations:
University of Texas MD Anderson Cancer Center,Houston,United States
,
Matthew S. Davids
Affiliations:
Dana-Farber Cancer Institute,Boston,United States
,
Michael Choi
Affiliations:
UCSD Moores Cancer Center,San Diego,United States
,
Richard R. Furman
Affiliations:
Weill Cornell Medicine,New York,United States
,
Anthony Mato
Affiliations:
Memorial Sloan Kettering Cancer Center,New York,United States
,
Lang Zhou
Affiliations:
AbbVie, Inc.,North Chicago,United States
,
Maria Verdugo
Affiliations:
AbbVie, Inc.,North Chicago,United States
,
Jalaja Potluri
Affiliations:
AbbVie, Inc.,North Chicago,United States
Steven Coutre
Affiliations:
Stanford Cancer Center, Stanford University School of Medicine,Stanford,United States
EHA Library. C. Byrd J. Jun 15, 2018; 214814; PF340
John C. Byrd
John C. Byrd
Contributions
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Abstract

Abstract: PF340

Type: Poster Presentation

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

Location: Poster area

Background
Therapies are urgently needed for patients (pts) with CLL relapsed/refractory (R/R) to BCRi.

Aims
We report outcomes for the full trial population from an ongoing phase 2 trial with VEN monotherapy, including the impact on detectable minimal residual disease (MRD).  

Methods
Pts with CLL R/R to ibrutinib and/or idelalisib received 400 mg daily VEN after initial dose ramp up. Results are from a data cut on 28Nov2017.

Results
Pts (N=127) had received a median of 4 prior therapies (1 – 15). Del(17p) was noted in 40% (50/126) and 28% (34/122) of pts had mutated TP53.

After a median of 17 (.1 – 36) months on VEN, the best overall response rate was 66% (84/127; CR/CRi – 10%, nPR/PR – 56%) per investigators (INV) and 70% (89/127) by independent review committee (IRC). Per INV (median follow up, 16 [.03 – 33] months), estimated median progression-free survival (PFS) was 25 months (18-month rate, 66%); neither median duration of response (18-month rate: 75%) nor median overall survival (18-month rate: 88%) was reached. 36/77 pts assessed (47%; 28% [36/127] by intent to treat) had undetectable blood MRD, 9/26 assessed were also undetectable in marrow (2 CR/CRi, 7 PR). Median PFS was longer for pts with undetectable MRD in blood vs positive (not reached vs 21.9 months; HR, .148 [.04 – .49], p=.0019).

64 pts discontinued VEN, most commonly for CLL progression (n=35; median time, 10 months [.1 – 29]), AEs (n=8), and Richter’s transformation (n=6; median time, 13 months [4 – 19]). Common any-grade AEs were GI AEs (diarrhea [50%], nausea [49%]) and cytopenias (anemia [43%], neutropenia [41%], thrombocytopenia [28%], decreased white blood cell count [28%]). 

n (%)

Last prior BCRi

N=127

Ibrutinib

n=91

Idelalisib

n=36

 

INV

IRC

INV

IRC

INV

IRC

ORR

59 (65)

64 (70)

25 (69)

25 (69)

84 (66)

89 (70)

CR

CRi

5 (6)

4 (4)

0

1 (1)

2 (6)

2 (6)

0

0

7 (6)

6 (5)

0

1 (1)

nPR

PR

3 (3)

47 (52)

0

63 (69)

0

21 (58)

0

25 (69)

3 (3)

68 (54)

0

88 (69)

SD

21 (23)

27 (30)

 

 

9 (25)

 

11 (31)

30 (24)

38 (30)

PD

5 (6)

2 (6)

7 (6)

Early discontinuation

6 (7)

0

6 (5)

 

Conclusion
Based on longer follow up, VEN monotherapy demonstrates robust activity, with good tolerability in pts with CLL R/R to ibrutinib and/or idelalisib. Though most pts achieved PR, outcomes appear durable with undetectable MRD.    

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

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