Table 5.

Comparison of OS and ORR for the JULIET ITT vs CORAL follow-up ITT populations

MethodNMedian (95% CI) OS, moHR (JULIET vs CORAL Follow up)
JULIETCORAL follow-upJULIETCORAL follow-upEstimate (95% CI)P
OS       
 Unadjusted analyses 166 205 8.25 (5.82, 11.70) 5.13 (3.88, 6.21) 0.65 (0.51, 0.83) <.001* 
 Adjusted analyses† 
  FSW 163 205 8.25 (5.82, 12.42) 4.86 (3.52, 6.08) 0.60 (0.44, 0.77) <.001* 
  SMRW 163 205 8.25 (5.82, 12.42) 4.04 (3.25, 5.75) 0.57 (0.44, 0.73) <.001* 
MethodNMedian (95% CI) OS, moHR (JULIET vs CORAL Follow up)
JULIETCORAL follow-upJULIETCORAL follow-upEstimate (95% CI)P
OS       
 Unadjusted analyses 166 205 8.25 (5.82, 11.70) 5.13 (3.88, 6.21) 0.65 (0.51, 0.83) <.001* 
 Adjusted analyses† 
  FSW 163 205 8.25 (5.82, 12.42) 4.86 (3.52, 6.08) 0.60 (0.44, 0.77) <.001* 
  SMRW 163 205 8.25 (5.82, 12.42) 4.04 (3.25, 5.75) 0.57 (0.44, 0.73) <.001* 
MethodNORR, (%)Response rate difference (JULIET Main Cohort vs CORAL Follow-up)
JULIET main cohortCORAL follow-upJULIET main cohortCORAL follow-upEstimate (95% CI)P
ORR       
 Unadjusted analyses 146 205 37% 30% 0.07 (–0.03, 0.17) .191 
 Adjusted analyses† 
  FSW 143 205 38% 29% 0.09 (–0.01, 0.20) .097 
  SMRW 143 205 38% 27% 0.11 (0.00, 0.22) .043* 
MethodNORR, (%)Response rate difference (JULIET Main Cohort vs CORAL Follow-up)
JULIET main cohortCORAL follow-upJULIET main cohortCORAL follow-upEstimate (95% CI)P
ORR       
 Unadjusted analyses 146 205 37% 30% 0.07 (–0.03, 0.17) .191 
 Adjusted analyses† 
  FSW 143 205 38% 29% 0.09 (–0.01, 0.20) .097 
  SMRW 143 205 38% 27% 0.11 (0.00, 0.22) .043* 
*

P < .05.

†

Age at initial diagnosis, status of disease, time to 2L start after diagnosis, prior HCT, and number of relapses were included in the adjusted analysis.

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