Efficacy of venetoclax plus rituximab for relapsed CLL: 5-year follow-up of continuous or limited- duration therapy

Ma, S; Seymour, JF; Brander, DM; Kipps, TJ; Choi, MY; Anderson, MA; Humphrey, K; Al Masud, A; Pesko, J; Nandam, R; Salem, AH; Chyla, B; Arzt, J; Jacobson, A; Kim, SY; Roberts, AW

Author(s): Ma, S; Seymour, JF; Brander, DM; Kipps, TJ; Choi, MY; Anderson, MA; Humphrey, K; Al Masud, A; Pesko, J; Nandam, R; Salem, AH; Chyla, B; Arzt, J; Jacobson, A; Kim, SY; Roberts, AW;
Details: Publication Year 2021-09-09,Volume 138,Issue #10,Page 836-846
Journal Title: Blood
Abstract: We report long-term follow-up of the phase 1b study of venetoclax and rituximab (VenR) in patients with relapsed chronic lymphocytic leukemia (CLL), including outcomes with continuous or limited-duration therapy. Patients received venetoclax daily (200-600 mg) and rituximab over 6 months and then received venetoclax monotherapy. Patients achieving complete response (CR), CR with incomplete marrow recovery (CRi), or undetectable minimal residual disease (uMRD) assessed by flow cytometry (<10-4 cutoff) were allowed, but not required, to discontinue therapy, while remaining in the study and could be retreated with VenR upon progression. Median follow-up for all patients (N = 49) was 5.3 years. Five-year rates (95% CI) for overall survival, progression-free survival, and duration of response were 86% (72-94), 56% (40-70), and 58% (40-73), respectively. Of the 33 deep responders (CR/CRi or uMRD), 14 remained on venetoclax monotherapy (continuous therapy), and 19 stopped venetoclax therapy (limited-duration therapy) after a median of 1.4 years. Five-year estimates of ongoing response were similar between continuous (71%; 95% CI, 39-88) or limited-duration therapy (79% [49-93]). Six of 19 patients in the latter group had subsequent disease progression, all >2 years off venetoclax (range, 2.1-6.4). Four patients were retreated with VenR, with partial responses observed in the 3 evaluable to date. VenR induced deep responses that were highly durable with either continuous or limited-duration therapy. Retreatment with VenR induced responses in patients with CLL progression after discontinuing therapy. Continuous exposure to venetoclax in deep responders does not appear to provide incremental benefit.
Publisher: ASH
Research Division(s): Blood Cells And Blood Cancer
PubMed ID: 34115103
Publisher's Version: https://doi.org/10.1182/blood.2020009578
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2021-10-26 10:03:52

Last Modified: 2021-10-29 11:02:30