Summary of results of key randomized trials for frontline therapy of patients with chronic myeloid leukemia in chronic phase
| Parameter . | . | JALSG CML212 . | DASISION . | ENESTnd . | BFORE . | ASC4FIRST∗ . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dasatinib . | Nilotinib . | Dasatinib . | Imatinib . | Nilotinib 300 mg . | Imatinib . | Bosutinib . | Imatinib . | Asciminib∗∗ . | Imatinib . | 2G-TKI . | ||
| Age | Median (range) | 53 (17-90) | 53 (19-85) | 46 (18-84) | 49 (18-78) | 47 (18-85) | 46 (18-80) | 52 (18-84) | 53 (19-84) | 52 (18-79) | 56 (21-79) | 43 (18-76) |
| High risk‡ | % | 18.5 | 18.9 | 19 | 19 | 28 | 28 | 20.7 | 21.2 | 11.4 | 7.8 | 13.7 |
| EMR§ | 3 mo | 73.1% | 74.5% | 84% | 64% | 91% | 67% | 80.6% | 60.5% | 89.6% | 59.8% | 80.4% |
| MMR | 12 mo | 69%|| | 63%|| | 46% | 28% | 55% | 27% | 47.2% | 36.9% | 67.7%¶ | 40.2% | 57.8% |
| 24 mo | 75%|| | 72%|| | 64% | 46% | 71% | 44% | 66% | 57.4% | NR | NR | NR | |
| MR4 | 12 mo | 35%|| | 36%|| | NR | NR | 20% | 6% | 20.7% | 12.0% | 38.8% | 14.7% | 26.5% |
| 24 mo | 50%|| | 48%|| | NR | NR | 39% | 18% | 26.6% | 34.3% | NR | NR | NR | |
| MR4.5 | 12 mo | 23.3% | 25.1% | 5% | 3% | 11% | 1% | 8.1% | 3.3% | 16.9% | 4.9% | 12.7% |
| 18 mo | 30.8% | 32.6% | 13%† | 7%† | 21%† | 6%† | NR | NR | NR | NR | NR | |
| 24 mo | 36.6% | 37.4% | 17% | 8% | 25% | 9% | 20.4% | 15.2% | NR | NR | NR | |
| Treatment change/discontinued | 1-3 y | 35.0% (3 y) | 33.5% (3 y) | 23% (2 y) | 25% (2 y) | 25.5% (2 y) | 32.5% (2 y) | 18.3% (1 y) | 17.7% (1 y) | 13.4%# | 36.2%# | 23.5%# |
| 5 y | NR | NR | 39% | 37% | 40.1% | 50.2% | 40.3% | 41.9% | NR | NR | NR | |
| Parameter . | . | JALSG CML212 . | DASISION . | ENESTnd . | BFORE . | ASC4FIRST∗ . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dasatinib . | Nilotinib . | Dasatinib . | Imatinib . | Nilotinib 300 mg . | Imatinib . | Bosutinib . | Imatinib . | Asciminib∗∗ . | Imatinib . | 2G-TKI . | ||
| Age | Median (range) | 53 (17-90) | 53 (19-85) | 46 (18-84) | 49 (18-78) | 47 (18-85) | 46 (18-80) | 52 (18-84) | 53 (19-84) | 52 (18-79) | 56 (21-79) | 43 (18-76) |
| High risk‡ | % | 18.5 | 18.9 | 19 | 19 | 28 | 28 | 20.7 | 21.2 | 11.4 | 7.8 | 13.7 |
| EMR§ | 3 mo | 73.1% | 74.5% | 84% | 64% | 91% | 67% | 80.6% | 60.5% | 89.6% | 59.8% | 80.4% |
| MMR | 12 mo | 69%|| | 63%|| | 46% | 28% | 55% | 27% | 47.2% | 36.9% | 67.7%¶ | 40.2% | 57.8% |
| 24 mo | 75%|| | 72%|| | 64% | 46% | 71% | 44% | 66% | 57.4% | NR | NR | NR | |
| MR4 | 12 mo | 35%|| | 36%|| | NR | NR | 20% | 6% | 20.7% | 12.0% | 38.8% | 14.7% | 26.5% |
| 24 mo | 50%|| | 48%|| | NR | NR | 39% | 18% | 26.6% | 34.3% | NR | NR | NR | |
| MR4.5 | 12 mo | 23.3% | 25.1% | 5% | 3% | 11% | 1% | 8.1% | 3.3% | 16.9% | 4.9% | 12.7% |
| 18 mo | 30.8% | 32.6% | 13%† | 7%† | 21%† | 6%† | NR | NR | NR | NR | NR | |
| 24 mo | 36.6% | 37.4% | 17% | 8% | 25% | 9% | 20.4% | 15.2% | NR | NR | NR | |
| Treatment change/discontinued | 1-3 y | 35.0% (3 y) | 33.5% (3 y) | 23% (2 y) | 25% (2 y) | 25.5% (2 y) | 32.5% (2 y) | 18.3% (1 y) | 17.7% (1 y) | 13.4%# | 36.2%# | 23.5%# |
| 5 y | NR | NR | 39% | 37% | 40.1% | 50.2% | 40.3% | 41.9% | NR | NR | NR | |
BFORE, Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment; DASISION, DASatinib versus Imatinib Study In treatment-Naive CML patients; ELTS, European Treatment and Outcomes Study long-term survival; EMR, early molecular response; NR, not reported.
Three-month data correspond to 12 weeks and 12-month data correspond to 48 weeks.
Per trial design based on abstracts reporting median follow-up of 18 months.
Sokal in JALSG, ENESTnd, and BFORE; Hasford in DASISION; and ELTS in ASC4FIRST.
BCR::ABL1 ≤10%.
As reported at the Annual Meeting of the American Society of Hematology 2020.4
Rate reflects the overall population of patients receiving asciminib. For patients randomized to asciminib who, before randomization, were allocated to the imatinib or second-generation TKI strata whether they were assigned to the control arm, MMR at 48 weeks were 69.3% and 66%, respectively.
At data cutoff with a median follow-up of 16.3 months with asciminib, 13.7 months with imatinib, and 17.0 months with second-generation TKI.
Data presented for full analysis set of patients.