VIALE-C
Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial
Phase 3N = 211NCT03069352
- Population
- Adults aged 18 years or older with newly diagnosed AML ineligible for intensive chemotherapy (median age 76 years, range 36 to 93; 38% secondary AML; 20% prior hypomethylating agent treatment)
- Design
- International randomized (2:1), double-blind, placebo-controlled phase 3 trial of venetoclax or placebo in 28-day cycles plus low-dose cytarabine (LDAC) on days 1 to 10. Primary end point: overall survival; secondary end points included response rate, transfusion independence and event-free survival.
- Primary endpoint
- OS
- Arms
- Venetoclax + LDAC (experimental, n = 143): Venetoclax plus low-dose cytarabine on days 1 to 10 of 28-day cycles
- Placebo + LDAC (control, n = 68): Placebo plus low-dose cytarabine on days 1 to 10 of 28-day cycles
- People
- Wei AH
OSHR 0.75 (95% CI 0.52–1.07)Δ median OS+3.1 monthsOSHR 0.70 (95% CI 0.50–0.98)Δ CR+CRi+35 points
Show the numbers
| Endpoint | Analysis | Venetoclax + LDAC | Placebo + LDAC | Effect |
|---|---|---|---|---|
| OSRandomized patients (N = 211); the abstract does not use the term ITT | primaryWei 2020 | median 7.2 months | median 4.1 months | HR 0.75 (95% CI 0.52–1.07)P=.11Not statistically significant in the planned primary analysis, as the abstract states. |
| OSRandomized patients (N = 211); the abstract does not use the term ITT | exploratoryWei 2020 | median 8.4 months | — | HR 0.70 (95% CI 0.50–0.98)P=.04Unplanned analysis with 6 months of additional follow-up, as labelled in the abstract; the control-arm median for this analysis is not given in the abstract. The confidence interval is that of the abstract (0.50 to 0.98); the Results text of the open-access full text gives 0.50 to 0.99. |
| CR+CRiRandomized patients (N = 211); the abstract does not use the term ITTComplete remission plus complete remission with incomplete blood count recovery | primaryWei 2020 | 48% | 13% | Secondary end point (the abstract lists response rate among the secondary end points). |
| Endpoint | Analysis | Venetoclax + LDAC | Placebo + LDAC | Effect |
|---|---|---|---|---|
| OSRandomized patients (N = 211); the abstract does not use the term ITT | primaryWei 2020 | median 7.2 months | median 4.1 months | HR 0.75 (95% CI 0.52–1.07)P=.11Not statistically significant in the planned primary analysis, as the abstract states. |
| OSRandomized patients (N = 211); the abstract does not use the term ITT | exploratoryWei 2020 | median 8.4 months | — | HR 0.70 (95% CI 0.50–0.98)P=.04Unplanned analysis with 6 months of additional follow-up, as labelled in the abstract; the control-arm median for this analysis is not given in the abstract. The confidence interval is that of the abstract (0.50 to 0.98); the Results text of the open-access full text gives 0.50 to 0.99. |
| CR+CRiRandomized patients (N = 211); the abstract does not use the term ITTComplete remission plus complete remission with incomplete blood count recovery | primaryWei 2020 | 48% | 13% | Secondary end point (the abstract lists response rate among the secondary end points). |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 0.75 | 0.52–1.07 |
| OS | 0.7 | 0.5–0.98 |
- Venetoclax + LDAC (experimental)
- Placebo + LDAC (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Venetoclax + LDAC | Placebo + LDAC |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 5 | 61.8% | 42.9% |
| 9 | 42.0% | 21.8% |
| 14 | 26.0% | 9.4% |
| 18 | 17.7% | 4.8% |
- Venetoclax + LDAC (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Venetoclax + LDAC |
|---|---|
| 0 | 100.0% |
| 5 | 66.2% |
| 11 | 40.3% |
| 16 | 26.7% |
| 21 | 17.7% |