Tecartus demonstrated comparable effectiveness throughout age teams of sufferers with relapsed or refractory B-cell acute lymphoblastic leukemia, based on a real-world research offered on the 2024 ASH Annual Assembly.
Tecartus (brexucabtagene autoleucel) produced comparable therapy outcomes in sufferers aged 60 to 69 with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) in comparison with sufferers of different ages, based on findings from a real-world research offered on the 2024 ASH Annual Assembly.
Sufferers who had been lower than 60 years of age (220 sufferers) achieved an entire remission (CR)/CR with incomplete depend restoration (CRi) charge of 89%, together with a minimal residual illness (MRD)-negativity charge of 74%. Sufferers who had been 60 to 69 years of age (57 sufferers) additionally skilled a CR/CRi charge of 89%, with an MRD-negativity charge of 59%. These respective charges had been 94% and 67% amongst sufferers who had been 70 years of age or older (19 sufferers).
“The charges of CR had been comparable throughout the teams at roughly 90% and no statistically important distinction was detected between the teams,” Dr. Ibrahim Muhsen of Baylor Faculty of Drugs in Houston, Texas, stated through the presentation. “MRD-negativity charges had been numerically decrease amongst sufferers aged 60 to 69 in contrast with different teams.”
Furthermore, there have been no important variations in general survival (OS) between the lower than 60, 60 to 69 and 70-plus years age teams. The respective median OS values had been 695 days, not but reached and 673 days. The six-month OS charges had been 81%, 81% and 73%, respectively, and the 12-month OS charges had been 68%, 63% and 61%, respectively.
Glossary:
Full remission (CR): full disappearance of most cancers.
Incomplete depend restoration (CRI): blood counts haven’t absolutely returned to regular after therapy.
Minimal residual illness (MRD): small quantity of most cancers cells remaining after therapy.
MRD negativity: no detectable most cancers cells remaining after therapy.
MRD positivity: detectable most cancers cells remaining after therapy.
Total survival (OS): size of time a affected person lives after being identified with most cancers.
Development-free survival (PFS): size of time a affected person lives with out illness worsening.
Intravenous: via the vein.
ECOG efficiency standing of 0, 1, 2 or extra: a scale used to measure an individual’s practical potential and the way effectively they’ll carry out each day actions.
There was additionally no distinction in progression-free survival (PFS) by age and the median PFS values within the lower than 60, 60 to 69 and 70-plus years age teams had been 397 days, 393 days and 259 days. The six-month PFS charges had been 64%, 58% and 56%, respectively, and the 12-month PFS charges had been 51%, 52% and 38%.
“It ought to be famous that the 12-months PFS [rate] and median PFS had been decrease in sufferers aged 70 and above. Nonetheless, the variety of sufferers in that group was small, which makes it very arduous to attract any conclusions. Though we are able to see a plateau in direction of the tip, an extended follow-up interval is required to raised estimate what number of sufferers are cured by this strategy,” Muhsen commented.
Particulars of the Actual-World Examine
In October 2021, Tecartus was the primary CAR T-cell remedy accredited by the FDA for the therapy of grownup sufferers with relapsed or refractory B-cell precursor ALL; the regulatory resolution was supported by findings from the section 1/2 ZUMA-3 trial. Among the many 55 sufferers enrolled within the research, solely eight had been no less than 65 years previous and all of those sufferers achieved a CR/CRi.
“Though a number of research have demonstrated the security and efficacy of CAR T-cell therapies in older sufferers with lymphoma, knowledge on the efficacy and security of [Tecartus] in older sufferers with ALL stay very restricted,” Muhsen famous.
To conduct their research, investigators recognized grownup sufferers with B-ALL who acquired Tecartus from October 2021 to June 2024 throughout 40 US-based educational and neighborhood establishments utilizing the Actual-World Outcomes Collaborative of CAR-T in Grownup ALL (ROCCA) consortium database. The dataset included 318 sufferers who underwent apheresis to obtain Tecartus, 22 of whom weren’t infused and thus not included within the evaluation.
At baseline, the median age within the beneath 60 group was 36 years. Sixty-two p.c of sufferers had been male, and sufferers had been non-Hispanic White (44%), Hispanic (39%), or Black (7%). Sufferers had an ECOG efficiency standing of 0 (27%), 1 (52%) or 2 or extra (12%). ALL subtypes had been comprised of Philadelphia chromosome (Ph)-negative (47%), Ph-positive (29%), or Ph-like (22%) illness. The median follow-up was 309 days. Sufferers acquired a median of 4 prior strains of remedy, together with Blincyto (blinatumomab; 57%), Besponsa (inotuzumab; 45%) and/or allogeneic hematopoietic cell transplantation (HCT; 42%). Sufferers acquired bridging remedy with chemotherapy (42%), immunotherapy (17%) or focused remedy (14%), and most (51%) had lively illness pre-apheresis whereas 28% had an MRD-positive CR and 12% had an MRD-negative CR.
Within the 60 to 69 aged group, the median age was 64 years and 54% of sufferers had been male. The group included sufferers who had been non-Hispanic White (67%), Hispanic (18%), or Black (9%). Sufferers had an ECOG efficiency standing of 0 (12%), 1 (68%) or 2 or extra (11%). ALL subtypes included Ph-negative (53%), Ph-positive (37%), or Ph-like (11%) illness. The median follow-up time was 296 days. Sufferers acquired a median of three prior strains of remedy, together with Blincyto (60%), Besponsa (44%), and/or allogeneic HCT (46%) and acquired bridging remedy with chemotherapy (32%), immunotherapy (18%) or focused remedy (23%). Forty-six p.c of sufferers had lively illness, 25% had an MRD-positive CR and 24% had an MRD-negative CR pre-apheresis.
Moreover, sufferers within the 70-plus group had been a median age of 73 years and most sufferers had been male (53%). The group included sufferers who had been non-Hispanic White (74%), Hispanic (21%) or Black (5%). Sufferers had an ECOG efficiency standing of 0 (11%), 1 (53%) or 2 or extra (32%). ALL subtypes included Ph-negative (63%), Ph-positive (26%) or Ph-like (11%) illness. The median follow-up time was 395 days. Sufferers acquired a median of three prior strains of remedy, together with Blincyto (68%), Besponsa (26%) and/or allogeneic HCT (16%), and acquired bridging remedy with chemotherapy (42%), immunotherapy (26%) or focused remedy (11%). Forty-two p.c of sufferers had lively illness, 42% had an MRD-positive CR and 11% had an MRD-negative CR pre-apheresis.
Security Findings Are Largely Constant Throughout Age Teams
Sufferers within the beneath 60, 60 to 69 and 70-plus age teams skilled any-grade cytokine launch syndrome (CRS) at respective charges of 84%, 86% and 89%. Grade 3 (extreme) to 4 (life-threatening) CRS occurred at charges of 11%, 4% and 11%, respectively. Any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 48%, 56% and 79% of sufferers, respectively, and grade 3 to 4 ICANS occurred in 29%, 30% and 32% of sufferers, respectively.
By way of hematotoxicity, the median time to absolute neutrophil (white blood cell) depend restoration was 16 days, 15 days and 15 days within the beneath 60, 60 to 69 and 70-plus years previous teams. The respective median instances to platelet restoration had been 27 days, 31 days and 51 days. Sufferers in all three teams required intravenous immunoglobulin infusion inside 90 days (28% versus 18% versus 17%), granulocyte colony-stimulating issue (GCSF) use inside 30 days (43% versus 33% versus 33%), GCSF use inside 30 to 90 days (37% versus 30% versus 33%), thrombopoietin mimetics use on days 30 to 90 (6% versus 6% versus 6%) and purple blood cell transfusion from days 30 to 90 (14% versus 22% versus 6%). Eighteen p.c of sufferers within the beneath 60 group and 26% within the age 60 to 69 group required platelet transfusion from days 30 to 90. Sufferers in every group additionally skilled no less than one any-grade an infection (30% versus 30% versus 26%) and no less than one grade 3 or greater an infection (14% versus 4% versus 11%), respectively.
“The charges of a development issue transfusion help and infections weren’t greater in older sufferers,” Muhsen stated. “Our knowledge help and make sure that treating sufferers with B-ALL age 60 and older with Tecartus is possible. Longer follow-up and a bigger pattern dimension, notably within the 70-plus age group, are wanted.”
Reference:
“Efficacy and security of brexucabtagene autoleucel for relapsed/refractory B-cell acute lymphoblastic leukemia in sufferers aged 60 and above.” By Dr. Ibrahim Muhsen, et al., Blood.
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