Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma

Maloney, David G.; Kuruvilla, John; Liu, Fei Fei; Kostic, Ana; Kim, Yeonhee; Bonner, Ashley; Zhang, Yixie; Fox, Christopher P.; Cartron, Guillaume

doi:10.1186/s13045-021-01144-9

Table 2 Comparison of clinical factors and SMDs before and after MAIC for OS

From: Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma

Clinical factor	OS
	ZUMA-1 (axi-cel) phase 2 mITT set	TRANSCEND (liso-cel) LBCL efficacy set
	ZUMA-1 (axi-cel) phase 2 mITT set	Before MAIC (naïve)		After MAIC (SA1)		After MAIC (SA2)
N/ESS	N = 101	N = 256		ESS = 152.6		ESS = 98.9
N/ESS	Stat	Stat	SMD	Stat	SMD	Stat	SMD
Age, years, mean (SD)	56.3 (12.0)	60.3 (13.3)	0.308	56.3 (12.0)	0.000	56.3 (12.0)	0.000
Male sex, %	67.3	66.0	0.027	68.3	0.020	67.3	0.000
IPI score, %*
0–2	54.5	58.6	0.162	54.5	0.000	54.5	0.000
3–4	45.5	39.8		45.5		45.5
5	0.0	0.8		0.0		0.0
Missing	0.0	0.8		0.0		0.0
ECOG PS at screening, %
0	41.6	40.6	0.178	37.9	0.075	41.6	0.000
1	58.4	57.8		62.1		58.4
2	0.0	1.6		0.0		0.0
Disease stage, %
I or II	14.9	27.0	0.304	23.5	0.219	14.9	0.000
III or IV	85.1	72.3		76.5		85.1
Missing	0.0	0.8		0.0		0.0
Tumor burden based on SPD before LDC, cm², mean (SD)^†	50.4 (43.7)	43.7 (48.1)	0.142	50.4 (43.8)	0.000	50.4 (43.9)	0.000
Secondary CNS disease at time of treatment, %
No	100.0	97.7	0.219	100.0	0.000	100.0	0.000
Yes	0.0	2.3		0.0		0.0
Extranodal disease, %
No	30.7	46.9	0.344	42.9	0.255	30.7	0.000
Yes	69.3	52.3		57.1		69.3
Missing	0.0	0.8		0.0		0.0
Bulky disease, %
No	83.2	87.9	0.155	83.2	0.000	83.2	0.000
Yes	16.8	11.3		16.8		16.8
Missing	0.0	0.8		0.0		0.0
Disease histology, %
DLBCL^‡	76.2	71.1	0.242	76.3	0.000	76.3	0.000
DLBCL tFL	15.8	22.3		15.8		15.8
PMBCL	7.9	5.5		7.9		7.9
FL3B	0.0	1.2		0.0		0.0
No. of lines of prior therapy, %^§
1	3.0	0.8	0.179	0.2	0.228	3.0	0.000
2	27.7	25.0		25.9		27.7
≥ 3	69.3	73.8		73.9		69.3
Missing	0.0	0.4		0.0		0.0
Prior allo-HSCT, %	0.0	2.7	0.237	0.0	0.000	0.0	0.000
Prior auto-HSCT, %	24.8	33.2	0.186	31.4	0.148	24.8	0.000
Bridging therapy, %
No	100.0	41.4	1.682	35.0	1.925	35.9	1.889
Yes	0.0	58.6		65.0		64.1
R/R to last therapy, %^¶
Relapsed	20.8	35.9	0.359	20.8	0.000	20.8	0.000
Refractory	79.2	61.7		79.2		79.2
Missing	0.0	2.3		0.0		0.0
CrCl before LDC, %^#
< 60 mL/min	0.0	19.1	0.688	13.4	0.557	0.0	0.000
≥ 60 mL/min	100.0	80.9		86.8		100.0
LVEF at screening, %^#
< 50%	0.0	5.1	0.327	4.3	0.300	0.0	0.000
≥ 50%	100.0	94.9		95.7		100.0
Pre-leukapheresis ALC (10⁹/L), %^#
< 0.1	0.0	0.4	0.091	0.2	0.067	0.0	0.000
≥ 0.1	100.0	94.1		94.2		100.0
Missing	0.0	5.5		5.6		0.0
Statistics, %
Factors with SMD < 0.2	NA	44.4	NA	66.7	NA	94.4	NA
Factors with SMD < 0.1	NA	11.1	NA	61.1	NA	94.4	NA

ALC, absolute lymphocyte count; allo-HSCT, allogeneic hematopoietic stem cell transplantation; auto-HSCT, autologous hematopoietic stem cell transplantation; axi-cel, axicabtagene ciloleucel; CNS, central nervous system; CrCl, creatinine clearance; DLBCL, diffuse large B cell lymphoma; ECOG PS, Eastern Cooperative Oncology Group performance status; ESS, effective sample size; FL3B, follicular lymphoma grade 3B; HGBCL, high-grade B cell lymphoma; IPI, International Prognostic Index; LBCL, large B cell lymphoma; liso-cel, lisocabtagene maraleucel; LDC, lymphodepleting chemotherapy; LVEF, left ventricular ejection fraction; MAIC, matching-adjusted indirect comparison; mITT, modified intention to treat; N, sample size; NA, not applicable; NOS, not otherwise specified; OS, overall survival; PMBCL, primary mediastinal B cell lymphoma; R/R, relapsed or refractory; SA1, sensitivity analysis 1; SA2, sensitivity analysis 2; SD, standard deviation; SMD, standard mean difference; SPD, sum of the product of perpendicular diameters; Stat, statistic; tFL, transformed follicular lymphoma; tiNHL, transformed indolent non-Hodgkin lymphoma
^*Per ZUMA-1 categorization
^†Per investigator assessment
^‡Includes DLBCL NOS, HGBCL, and tiNHL for TRANSCEND; includes DLBCL NOS and HGBCL for ZUMA-1
^§Per ZUMA-1, salvage chemotherapy and auto-HSCT were considered separate regimens
^¶Per ZUMA-1, refractory was defined as best response to last therapy of progressive disease or stable disease and relapsed defined as best response to last therapy of partial response or complete response
^#Per ZUMA-1 eligibility criteria, all patients enrolled in ZUMA-1 had CrCl ≥ 60 mL/min before LDC, LVEF ≥ 50% at screening, and pre-leukapheresis ALC ≥ 0.1 × 10⁹/L

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