Table 1. HGBL outcomes in pivotal CAR... | American Society of Hematology

Table 1.

HGBL outcomes in pivotal CAR T-cell studies

	ZUMA-1 Locke et al⁵⁴	JULIET Schuster et al⁸³	TRANSCEND Abramson et al⁸⁴	ZUMA-7 Locke et al⁵⁹		BELINDA Bishop et al⁶⁰^,*		TRANSFORM Kamdar et al⁶¹^,*		ZUMA-12 Neelapu et al⁶³,†
				Axi-cel	SOC	Tisa-cel	SOC	Liso-cel	SOC
Phase	1/2	2	Seamless	3		3		3		2
	Axicabtagene ciloleucel	Tisagenlecleucel	Lisocabtagene maraleucel	Axicabtagene ciloleucel		Tisagenlecleucel		Lisocabtagene maraleucel		Axicabtagene ciloleucel
Primary endpoint	ORR	ORR	ORR	EFS		EFS after wk 12		EFS		CR
Patient characteristics
No. of patients	101	111	256	180	179	162	160	92	92	40
No. of HGBL	7	19	36	31	26	32	19	21	22	10
Clinical outcomes
Total cohort
ORR, %	82	52 (3 mo)‡	72.7	83	50	46.3	42.5	86	48	90
CR, %	54	40	53.1	65	32	28.4 (3 mo)	27.5	66	39	80
EFS (HR)				0.40		1.07		0.349		Not reached
HGBL
ORR, %	100	50	75.8	81	42	NR	NR	NR	NR
CR, %	67	25	60.6
EFS (HR)				0.47§
Median follow-up, mo	27.1	28.6	18.8	24.9		10		6.2		15.9

	ZUMA-1 Locke et al⁵⁴	JULIET Schuster et al⁸³	TRANSCEND Abramson et al⁸⁴	ZUMA-7 Locke et al⁵⁹		BELINDA Bishop et al⁶⁰^,*		TRANSFORM Kamdar et al⁶¹^,*		ZUMA-12 Neelapu et al⁶³,†
				Axi-cel	SOC	Tisa-cel	SOC	Liso-cel	SOC
Phase	1/2	2	Seamless	3		3		3		2
	Axicabtagene ciloleucel	Tisagenlecleucel	Lisocabtagene maraleucel	Axicabtagene ciloleucel		Tisagenlecleucel		Lisocabtagene maraleucel		Axicabtagene ciloleucel
Primary endpoint	ORR	ORR	ORR	EFS		EFS after wk 12		EFS		CR
Patient characteristics
No. of patients	101	111	256	180	179	162	160	92	92	40
No. of HGBL	7	19	36	31	26	32	19	21	22	10
Clinical outcomes
Total cohort
ORR, %	82	52 (3 mo)‡	72.7	83	50	46.3	42.5	86	48	90
CR, %	54	40	53.1	65	32	28.4 (3 mo)	27.5	66	39	80
EFS (HR)				0.40		1.07		0.349		Not reached
HGBL
ORR, %	100	50	75.8	81	42	NR	NR	NR	NR
CR, %	67	25	60.6
EFS (HR)				0.47§
Median follow-up, mo	27.1	28.6	18.8	24.9		10		6.2		15.9

HR, hazard ratio; NR, not reported.

Subset analyses of endpoints in HGBL subtype were not provided in BELINDA and TRANFORM trials.

†

Patients were considered high risk if they had DH or TH lymphoma or an IPI score ≥3 plus a positive interim positron emission tomography scan (Deauville score 4 or 5) after 2 cycles of anti-CD20 monoclonal antibody and anthracycline-containing regimen. Of the 40 patients who were treated, 25% patients had DH or TH lymphoma.

‡

5-year follow-up is available: Schuster et al.⁵³ ORR: 38.3% (CI, 29.4-47.8) in all patients and 20% (CI, 5.7-43.7) in HGBL.

Disease type according to the investigator. HR for EFS when disease type according to central laboratory was: 0.28.

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