Older Patients With Relapsed Refractory Diffuse Large B cell Lymphoma Treated With Axi-cel Have Better Outcomes Compared With Chemoimmunotherapy

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma, and patients with relapsed or refractory disease often have poor prognoses. This is particularly true for older adults, with comorbidities along with an increased risk for mortality and severe toxicity from intensive salvage chemoimmunotherapy (CIT) and may not be eligible for autologous stem cell transplantation. Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, is approved by the U.S. Food and Drug Administration (FDA) as a second-line treatment for patients with Large B cell Lymphoma. A post-hoc analysis from the ZUMA-1 trial and a survival analysis from the ZUMA-7 trial demonstrated the effectiveness of axi-cel in patients aged ≥65 years in the relapse and refractory setting.

We summarise the findings of a recent real world data analysis comparing the outcomes of patients aged ≥65 years, with relapsed and refractory DLBCL who receive axi-cel and CIT, published by Lunning et al in American Journal of Hematology

 

Study design and patient population

  • A total of 1146 patients treated with commercial axi-cel for R/R LBCL with ≥2 lines of prior therapy were included from the Center for International Blood and Marrow Transplantation Research (CIBMTR) prospective observational study, and 469 patients treated with CIT for R/R LBCL after ≥2 lines of prior therapy were included from SCHOLAR-1
  • Endpoints were overall response rate, complete response rate (CR), and overall survival (OS).
  • Median follow-up was 24.5 months and 59.8 months in the axi-cel and CIT groups, respectively.
What is ECOG* Performance Status
The ECOG Performance Status is a scale used by doctors to assess a cancer patient’s level of functioning.

It helps determine how well the patient can perform everyday tasks and how their cancer might be affecting them physically.

  • ECOG 0
Fully active, able to perform all of their usual activities of daily living without any limitations
  • ECOG 1
Restricted in terms of strenuous activity, but able to do light housework or office work.
  • ECOG 2
Mobile, ambulant, and capable of all selfcare, but unable to carry out any work activities. In bed < 50& of the day.
  • ECOG 3
Capable of only limited selfcare. In bed > 50% of the day.
  • ECOG 4
Patient is completely disabled and unable to carry on any selfcare

 

*ECOG, Eastern Cooperative Oncology Group (ECOG) performance status

 

Key findings

Patient characteristics

Patients who received axi-cel were older, tend to have ECOG < 2 and tend to have experienced more lines of prior therapies.

Baseline Characteristics
(%)
Axi-cel
(n=1,146)
CIT
(n=469)
Median age, years (range)
<65 years
≥ 65 years
≥ 70 years
62.3 (19.6 – 86.2)
61
39
20
55.4 (19.8-81.2)
86
14
6
ECOG PS
0-1
>2
Unknown
85
4
11
63
11
26
Number of prior lines of therapy
2
≥ 3
34
66
96
4
Prior ASCT
No
Yes
72
28
76
24

Axi-cel, axicabtagene ciloleucel; CIT, chemoimmunotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; ASCT, Autologous Stem Cell Transplant.
Results adapted from Lunning, et al.1

Patients who received axi-cel were older, tend to have ECOG < 2 and tend to have experienced more lines of prior therapies.

 

End points

  • The estimated OS rate at 12 months in the survival analysis set after propensity score matching was 62% (95% CI, 58–66) in patients who received axi-cel versus 28% (95% CI, 24–33) in patients who received CIT 
  • 12-month overall survival rates were 62% for patients who received Axi-cel and 28% for patients who received CIT.
  • The overall response rate and CR were higher amongst patients who received Axi-cel compared to patients who received CIT across all subgroups of patients aged <65 and ≥65 years and patients with ECOG PS <2 and ECOG PS = 2 as shown in the following figure.

 

Axi-cel, axicabtagene ciloleucel; CIT, chemoimmunotherapy; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; ORR, overall response rate.

Results adapted from Lunning, et al.1

 

Key Learning Points
  • Real-world data comparing the use of Axi-cel and chemoimmunotherapy amongst the difficult-to-treat population of patients with relapsed and refractory DLBCL
  •  Higher overall response rate and complete response rate observed in patients ≥ 65 patients treated with Axi-cel
  • This analysis supports the use of Axi-cel in older patients with poor performance status

References:

  1. Lunning MA, Wang HL, Hu ZH, et al. Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B-cell lymphoma after 2 or more lines of prior therapy. AM J Hematol. 2024;99(5):880-889. DOI: 1002/ajh.27283

Disclaimer:
The information on the Centre For Clinical Haematology website is intended for educational use.  It should not be considered or used as a substitute for medical advice, diagnosis or treatment from a qualified health professional.

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