Table 3.

Clinical Variables Predictive of Overall Survival (Intent‐to‐Treat Population)

Variable	Subsets Analyzed	Hazard Ratio (95% CI)	2‐Sided P
InO arm (n = 123)
Best MRD status	Positive (n = 36)	1.99 (1.19‐3.31)	.0085
	Negative (n = 87)
Baseline platelets	<100 × 109/L (n = 85)	1.65 (0.96‐2.86)	.0729
	≥100 × 109/L (n = 38)
Baseline hemoglobin	<10 g/dL (n = 53)	1.60 (1.01‐2.55)	.0463
	≥10 g/dL (n = 70)
Duration of first remissiona	Continuous (n = 123)	0.98 (0.97‐1.00)	.0157
CR/CRib	Yes (n = 103)	0.48 (0.26‐0.90)	.0214
	No (n = 20)
Follow‐up HSCT	Yes (n = 70)	0.40 (0.26‐0.61)	<.0001
	No (n = 53)
SoC arm (n = 80)
Age	<55 y (n = 47)	1.76 (1.04‐2.99)	.0363
	≥55 y (n = 33)
Baseline platelets	<100 × 109/L (n = 44)	1.70 (1.01‐2.85)	.0452
	≥100 × 109/L (n = 36)
Prior HSCT	Yes (n = 17)	0.28 (0.14‐0.56)	.0003
	No (n = 63)
Follow‐up HSCT	Yes (n = 23)	0.15 (0.08‐0.31)	<.0001
	No (n = 57)

Abbreviations: CI, confidence interval; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; HSCT, hematopoietic stem cell transplantation; InO, inotuzumab ozogamicin; MRD, minimal residual disease; SoC, standard of care.

Only variables predictive of outcomes are shown in the table. The variables included in the stepwise Cox regression modeling were as follows: age (continuous), age (< or ≥55 years), sex, central CD22 (< or ≥90%), baseline hemoglobin (< or ≥10 g/dL), baseline platelets (< or ≥100 × 10⁹/L), baseline absolute circulating blasts (< or ≥1 × 10⁹/L), baseline percentage of bone marrow blasts (continuous), salvage status at randomization (2 or 1), presence of extramedullary disease (yes or no), prior HSCT (yes or no), primary refractory (yes or no), response to most recent prior regimen (CR or other), duration of first remission per case report form (continuous), dual alkylator during conditioning therapy (yes or no), donor for HSCT (alternate or matched related), best MRD status (positive or negative), CR/CRi per the investigator’s assessment (yes or no), CR/CRi at the last assessment before HSCT (yes or no), last platelet value recorded before transplantation (< or ≥100 × 10⁹/L), and last bilirubin measurement recorded before transplantation (< or ≥ upper limit of normal).

^aAccording to the case report form.

^bAccording to the investigator’s assessment.