Table 2.

Overall long-term outcomes and by MRD complete response and nonresponse in cycle 1 (key secondary end point full analysis set)

All patientsMRD responders*MRD nonresponders*
OS
 Patients with events, n/N48/11031/8514/22
 Median (95% CI)36.5 (19.8-NR)38.9 (33.7-NR)12.5 (3.2-NR)
 Estimated probability at 18 months (95% CI)0.67 (0.58-0.75)0.70 (0.59-0.79)0.34 (0.15-0.54)
 P.002
Hematologic RFS
 Patients with events, n/N62/11040/8512/15
 Median (95% CI)18.9 (12.3-35.2)23.6 (17.4-NR)5.7 (1.6-13.6)
 Estimated probability at 18 months (95% CI)0.53 (0.44-0.62)0.58 (0.46-0.68)0.20 (0.05-0.42)
 P.002
Duration of hematologic remission§
 Patients with events, n/N38/11023/857/15
 Median (95% CI)NR (NR-NR)NR (NR-NR)NR (3.7-NR)
 Estimated probability at 18 months (95% CI)0.70 (0.61-0.78)0.77 (0.67-0.85)0.53 (0.30-0.80)
 P.14
  • n, patients with events (deaths for OS, death in CR, or relapse for RFS and relapse for duration of hematologic remission); N, patients at risk; NR, not reached.

  • * Landmark analysis includes patients in both the key secondary full analysis set and the primary end point analysis set and excludes patients with an event (death or relapse) or censored before day 45.

  • Kaplan-Meier estimate.

  • Log-rank test P value compared with MRD nonresponders.

  • § Duration of hematologic remission is evaluated by 1 − cumulative incidence function of hematologic relapse with death in CR as a competing event.

  • Gray’s test P value compared with MRD nonresponders.