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- Title
6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy.
- Authors
Wei, Andrew H.; Panayiotidis, Panayiotis; Montesinos, Pau; Laribi, Kamel; Ivanov, Vladimir; Kim, Inho; Novak, Jan; Stevens, Don A.; Fiedler, Walter; Pagoni, Maria; Bergeron, Julie; Ting, Stephen B.; Hou, Jing-Zhou; Anagnostopoulos, Achilles; McDonald, Andrew; Murthy, Vidhya; Yamauchi, Takahiro; Wang, Jianxiang; Chyla, Brenda; Sun, Yan
- Abstract
VIALE-C compared the safety and efficacy of venetoclax or placebo plus low-dose cytarabine (+LDAC) in patients with untreated AML ineligible for intensive chemotherapy. Overall, 211 patients were enrolled (n = 143, venetoclax; n = 68, placebo). At the primary analysis, the study did not meet its primary endpoint of a statistically significant improvement in overall survival (OS), however, ~60% of patients had been on study for ≤6-months. Here, we present an additional 6-months of follow-up of VIALE-C (median follow-up 17.5 months; range 0.1–23.5). Median OS was (venetoclax +LDAC vs. placebo +LDAC) 8.4 vs. 4.1 months (HR = 0.70, 95% CI 0.50,0.99; P = 0.040); a 30% reduction in the risk of death with venetoclax. Complete response (CR)/CR with incomplete hematologic recovery (CRi) rates were 48.3% vs. 13.2%. Transfusion independence rates (RBC) were 43% vs.19% and median event-free survival was 4.9 vs. 2.1 months (HR = 0.61; 95% CI 0.44,0.84; P = 0.002). These results represent improved efficacy over the primary analysis. Incidence of grade ≥3 adverse events were similar between study arms and overall safety profiles were comparable to the primary analysis. These data support venetoclax +LDAC as a frontline treatment option for patients with AML ineligible for intensive chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT03069352.
- Subjects
OVERALL survival; ACUTE myeloid leukemia; SURVIVAL rate; VENETOCLAX; CANCER chemotherapy
- Publication
Blood Cancer Journal, 2021, Vol 11, Issue 10, p1
- ISSN
2044-5385
- Publication type
Article
- DOI
10.1038/s41408-021-00555-8