Table 1 Comparison of randomized prospective studies on venetoclax-based combinations in AML: AZA + venetoclax vs LDAC + venetoclax

Phase

III VIALE-A trial

III VIALE-C trial

Population

Age > 75 years or unfit for chemotherapy

Control arm

AZA

LDAC

h/o HMA

No

Yes, allowed (20%)

Patient number

431

(286 in AZA + venetoclax)

211

(143 in LDAC + venetoclax)

Median age

(range), years

76 (49–91)

76 (36–93)

30-day mortality, %

7%

13%

cCR (CR) rate, %

66.4% (36.7%)

48% (27%)

MRD negativity, %

N/A

6%

Time to CR (response)

1.3 months (0.6–9.9)

N/A most response at the end of cycle 2

Median DOR, months

17.5 (13.6 to NR)

NA

Median OS, months

14.7 (11.9–18.7)

8.4 (5.9–10.1)

Reference

[7]

[8]