Decitabine with venetoclax is an appropriate salvage therapy, comparable to intensive chemotherapy regimens, for younger adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), according to the results of a comparative study presented by Abhishek Maiti, MBBS, of the University of Texas MD Anderson Cancer Center in Houston, Texas, at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

“Venetoclax with hypomethylating agents is potentially better than intensive chemotherapy as first-line treatment for older patients, even among those who are fit to receive intensive chemotherapy,” said Dr Maiti. “However, it is unknown how venetoclax with hypomethylating agents compares to intensive chemotherapy in relapsed or refractory AML.”

The investigators compared outcomes in adult patients with R/R AML who were treated with 10-day decitabine and venetoclax therapy (DEC10-VEN) in a prospective phase 2 trial (ClinicalTrials.gov Identifier: NCT03404193) with adult patients who underwent intensive chemotherapy (IC) without venetoclax in 2 prospective clinical 1b/2 trials (ClinicalTrials.gov Identifier: NCT02115295 and NCT01289457). They implemented a propensity score matched analysis, which used baseline characteristics to minimize bias in retrospective studies.


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Overall, 55 and 197 patients had been treated with DEC10-VEN (between January 2018 and December 2019) and IC (between February 2011 and January 2018), respectively, and the propensity score matching analysis optimally matched 54 patients together from each of the 2 treatment groups.

Baseline characteristics were well balanced between the 2 cohorts. The median age was 62 years (range, 18-84) in the DEC10-VEN cohort and 59 years (range, 27-69) in the IC cohort. The median number of prior lines of therapy was 2 (range, 1-8) in the DEC10-VEN cohort and 2 (range, 1-7) in the IC cohort.

Patients received a median of 2 cycles of therapy (range, 1-12) in DEC10-VEN cohort and a median of 1 cycle of therapy (range 1-7) in the IC cohort, and the median follow-up durations were 12.5 months and 22.5 months, respectively.

The overall response rate was higher with DEC10-VEN compared with IC (59% vs 31%, respectively; odds ratio [OR], 2.87; 95% CI, 1.29-6.43; P <.01). The composite complete remission rates (complete response or complete response with incomplete hematologic recover) were not significantly different between the DEC10-VEN and IC cohorts (41% vs 30%, respectively; OR, 95% CI, 0.74-3.62; P =.23). The rate of treatment failure was lower among patients in the DEC10-VEN cohort compared with patients in the IC cohort (39% vs 69%, respectively; OR, 0.33; 95% CI, 0.15-0.74; P <.01).

Both groups had a median number of cycles to best response of 1 (DEC10-VEN, range 1-4; IC, range 1-2). The 30-day mortality was 7% (n=4) with DEC10-VEN and 9% (n=5) with IC (OR 0.78, 95% CI 0.20, 3.09, P =.73).

The median event-free survival was significantly longer in the DEC10-VEN cohort compared with in the IC cohort (5.7 months vs 1.7 months; HR, 0.47; 95% CI, 0.26-0.85; stratified test P =.011). However, the median overall survival was not significantly different between the DEC10-VEN cohort and the IC cohort (7.1 months vs 5.5 months, respectively; HR, 0.78; 95% CI, 0.42-1.45; P =.435).

“[D]ecitabine with venetoclax is an appropriate salvage regimen comparable to non-venetoclax-based intensive chemotherapy, even in younger patients with relapsed refractory AML,” concluded Dr Maiti. “The higher overall response rate, longer event free survival, and better tolerability make this regimen an attractive choice for multiple relapsed patients, and as a bridge to stem cell transplantation. Finally, the lower rate of toxicities makes this regimen, an appropriate backbone for adding novel therapies in the salvage setting.”

Disclosure: Some authors have declared affiliations with or received funding from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

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Reference

Maiti A, DiNardo CD, Kadia TM, et al. Ten-day decitabine with venetoclax versus intensive chemotherapy in relapsed or refractory acute myeloid leukemia: a propensity score matched analysis. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstract 637.

This article originally appeared on Hematology Advisor