Table 3.
Summary of secondary endpoints.
| Secondary endpoint | Venetoclax +LDAC (n = 143) | Placebo + LDAC (n = 68) | P value |
|---|---|---|---|
| Remission rates, % (95% CI) | |||
| CR, % (95% CI) | 28.0 (20.8, 36.1) | 7.4 (2.4, 16.3) | <0.001 |
| Median DoR, months | 17.1 | 8.3 | |
| CR/CRi, % (95% CI) | 48.3 (39.8, 56.8) | 13.2 (6.2, 23.6) | <0.001 |
| Median time to first remission, months (range)a | 1.1 (0.8, 16.3) | 3.7 (0.9, 6.5) | |
| By initiation of cycle 2, % (95% CI) | 34.3 (26.5, 42.7) | 2.9 (0.4, 10.2) | |
| Median DoR, months | 11.7 | 6.2 | |
| CR/CRh, % (95% CI) | 48.3 (39.8, 56.8) | 14.7 (7.3, 25.4) | <0.001 |
| Median time to first remission, months (range)a | 1.0 (0.7, 16.3) | 2.8 (0.9, 6.5) | |
| By initiation of cycle 2, % (95% CI) | 30.8 (23.3, 39.0) | 4.4 (0.9, 12.4) | |
| Median DoR, months | 11.7 | 8.3 | |
| Post-baseline transfusion independence rates, % (95% CI) | |||
| RBC | 43.4 (35.1, 51.9) | 19.1 (10.6, 30.5) | <0.001 |
| Platelet | 49.0 (40.5, 57.4) | 32.4 (21.5, 44.8) | 0.024 |
| Both | 39.2 (31.1, 47.7) | 17.6 (9.5, 28.8) | 0.002 |
| Post-baseline transfusion independence rates by baseline transfusion statusb, % (95% CI) | |||
| RBC | |||
| Dependent at baseline | 40.4 (30.9, 50.5) | 16.7 (7.9, 29.3) | NPc |
| Independent at baseline | 51.3 (34.8, 67.6) | 28.6 (8.4, 58.1) | |
| Platelet | |||
| Dependent at baseline | 28.8 (17.1, 43.1) | 12.5 (2.7, 32.4) | NPc |
| Independent at baseline | 60.4 (49.6, 70.5) | 43.2 (28.3, 59.0) | |
| Both | |||
| Dependent at baseline | 35.1 (26.3, 44.8) | 14.3 (6.4, 26.2) | NPc |
| Independent at baseline | 53.1 (34.7, 70.9) | 33.3 (9.9, 65.1) | |
| Median EFS, months (95% CI) | 4.9 (3.7, 6.4) | 2.1 (1.5, 3.2) | 0.002 |
aOne patient in the venetoclax arm took 16.3 months to achieve their first response and this patient makes up the latter edge of the range described. All other patients in the venetoclax arm responded within 5 months. bBaseline transfusion status: transfusion-dependent at baseline if RBC or platelet transfusion received within 8 weeks of the first dose of study drug; transfusion independent at baseline if RBC or platelet transfusion was not received within 8 weeks of the first dose of study drug. cPer the statistical analysis plan (SAP), no statistical comparison was performed for conversion rates.
CI confidence interval, CR complete response, CRh complete response with partial hematologic recovery, CRi complete response with incomplete hematologic recovery, DoR duration of response, EFS event-free survival, LDAC low-dose cytarabine, NP not performed, RBC red blood cell.