Survival disparity in AML ‘appears to have been mitigated’ with front-line venetoclax
Key takeaways:
- OS increased in patients with AML older than 70 years and who identified as non-Hispanic Black.
- Hispanic patients had similar survival outcomes since the approval of venetoclax-based front-line therapy.
SAN DIEGO — Non-Hispanic Black patients with acute myeloid leukemia experienced the largest improvement in OS since the approval of venetoclax-based front-line therapy, according to data presented at ASH Annual Meeting and Exposition.
Researchers also observed improved survival outcomes in patients over the age of 70 years, whereas Hispanic patients still experienced similar outcomes as before venetoclax approval.
“It was reassuring for us to see that we are treating older and sicker patients and seeing improved overall survival in patients treated in the post-novel therapy era, particularly among patients over 70 years of age,” Xin Wang, MD, a hematology-oncology fellow physician at Penn Medicine, told Healio.
“This is a reflection of the true impact of the real-world application of novel therapeutics and the improvement of other aspects of AML care in general,” she added. “We were, however, pleasantly surprised by the fact that the largest OS improvement was observed in [non-Hispanic Black] patients, where the OS disparity between [non-Hispanic Black] and [non-Hispanic white] in pre-novel therapy era appears to have been mitigated.”
Background and methodology
Venetoclax-based front-line therapy (Venclexta; Genentech, AbbVie) received FDA approval in Nov. 2018, marking a new era in the treatment of patients with acute myeloid leukemia, according to study background.
Certain racial and ethnic disparities have persisted in AML care, especially regarding the disparity between patients that identify as non-Hispanic Black (NHB) and non-Hispanic white (NHW).
Researchers conducted a retrospective analysis utilizing real-world data to examine the potential magnitude the approval of venetoclax-based front-line therapy may have had on preexisting racial and ethnic disparities among patients receiving AML treatment.
The analysis included adults with AML tracked by Flatiron Health — a nationwide, electronic health record-derived, de-identified database — diagnosed between January 2014 to December 2018 and January 2019 to October 2022.
Eligibility criteria included patients who identified as NHB, NHW or Hispanic who had also received one prior line antileukemic therapy.
Researchers identified OS, defined as time from therapy initiation to time of death, as the primary study endpoint.
Results and next steps
Researchers labeled patients diagnosed with AML between January 2014 and December 2018 as being in the “pre-era” (n = 2,998; 2,566 NHW, 221 NHB, 211 Hispanic), while patients diagnosed between January 2019 and October 2022 as the “post-era” (n = 2,098; 1,809 NHW, 162 NHB, 127 Hispanic).
After adjusting for race and ethnicity, age and hematopoietic cell transplant-specific comorbidity index, patients treated in the post-era had approximately a 10% decrease in hazard of death compared with patients in the pre-era (HR = 0.9; 95% CI, 0.83-0.96).
Researchers found the to be driven by a large survival increase among patients older than 70 years (HR = 0.82; 95% CI, 0.75-0.91).
Researchers observed a 22% increase in hazard of death among NHB patients, when compared with NHW patients, in the pre-era (HR = 1.22; 95% CI, 1.04-1.43); meanwhile Hispanics had similar outcomes regardless of treatment era (HR = 1.01; 95% CI, 0.84-1.21).
The survival disparity between NHB and NHW patients in the pre-era did not appear in the post-era, with predicted 2-year OS rates of 45.3% for NHBs vs. 39.9% for NHWs (HR = 0.86; 95% CI, 0.69-1.08).
Predicted 2-year OS rates improved for NHB patients at 70 years of age and younger (42.3% vs. 53.2%) and NHB patients over 70 (13.6% vs. 37%).
“Overall, it is very exciting to see that we are making headway on caring and improving the outcomes of patients with AML, an aggressive disease with enormous biological heterogeneity, vigilant care needs, and historically dismal outcomes; and that we seem to be narrowing the survival gap between NHB and NHW with modern AML care,” Wang told Healio.
“So far, we showed the ‘what’ — changes occurred between the two treatment eras — but have not answered the ‘why' question clearly, which is even more important,” she added. “Moving forward, we are actively seeking collaborative opportunities with our colleagues from other institutions to formulate a more comprehensive real-world dataset to answer questions that cannot be answered in our current study due to its limitations.”
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Wang X, et al. Abstract 955. Presented at: ASH Annual Meeting and Exhibition; Dec. 9-12, 2023; San Diego.
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