All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.
2021-08-14T15:02:18.000Z

Results from the French DESCAR-T registry study: Use of cancer databases for the management of data from patients undergoing CAR-T cell therapy for the treatment of DLBCL

Aug 14, 2021
Share:

Bookmark this article

Patients with B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL) with refractory or relapsed (R/R) disease can face poor clinical outcomes and reduced survival. CAR-T cell therapy with tisagenlecleucel (tisa-cel) or axicabtagene ciloleucel (axi-cel) has been shown to improve long-term outcomes for these patients. Following successful clinical trials, long-term safety and efficacy data, pharmacovigilance, and real-word data are needed to inform patient safety and the long-term use and future health economics of CAR T-cell therapy.

Steven Le Gouill presented the first results from patients with DLBCL treated with CAR T-cell therapy and enrolled in the DESCAR-T registry, at the 17th International Conference on Malignant Lymphoma (17-ICML).1 Here we summarize the work of Steven Le Gouill and colleagues,1 describing real-world results from the French national registry of patients with hematologic malignancies treated with CAR-T cell therapy, focusing on patients with DLBCL.

Study design

DESCAR-T is the French national registry for patients with DLBCL and ALL treated with CAR T-cell therapy. All patients with DLBCL registered in DESCAR-T between December 2019 and April 2021 were eligible for the study; DESCAR-T, currently, has 19 enrolling sites.

The main outcomes were clinical outcomes, including overall response rate (ORR), complete remission (CR), progressive disease (PD), overall survival (OS), progression-free survival (PFS), and duration of response (DOR), as well as safety outcomes.

Results

647 patients with DLBCL were enrolled:

  • CAR-T was ordered in 607 patients:
    • CAR-T was not ordered in 10 patients for varying reasons, including patient outside of inclusion or exclusion criteria, patient refusal, infection, disease progression, and death.
    • Thirty patients are ongoing, five of whom have completed leukapheresis and 25 of whom are pending leukapheresis.
  • Of the 607 patients for whom CAR-T was ordered, 550 were treated:
    •  Of the 57 patients for whom CAR-T was ordered but not administered, four patients are ongoing, and 53 were not administered CAR-T due to various reasons (including disease progression, leukapheresis failure, physician decision, and death before administration).
    • Of the 550 patients who were treated, 200 received tisa-cel and 350 received axi-cel.

Key clinical data for the 550 patients who received CAR-T cell therapy, including demographic and diagnostic data, can be seen in Table 1.

Table 1. Clinical and demographic data for CAR-T treated patients*

Parameter

Result

Male/female

331/219

Median age at CAR-T order, years (range)

63 (18−79)

Diagnosis at registration, %

              DLBCL, NOS

90

              PMBL

4

              HGBL

1.7

              Others/missing

4.3

Median lines of treatment (range)

3 (1−10)

Prior auto-SCT, %

22.5

Prior allo-SCT, %

2

Median days from CAR-T order to TTT (IQR)

50 (43−60)

allo-SCT, allogeneic stem cell transplant; auto-SCT, autologous stem cell transplant; CAR-T, chimeric antigen receptor T-cell therapy; DLBCL, diffuse large B-cell lymphoma; HGBL, high-grade B-cell lymphoma; IQR, interquartile range; NOS, not otherwise specified; PMBL, primary mediastinal B-cell lymphoma; TTT, time to treatment.
*Adapted from Le Gouill et al.1

Safety data and adverse events

Data on specific toxicities experienced within 10 days of receiving CAR-T cell therapy were available in 515 patients and can be seen in Table 2, along with treatments for toxicities.

Table 2. CAR-T related adverse events*

Toxicity, %

All patients
(n = 515)

Axi-cel
(n = 322)

Tisa-cel
(n = 193)

Cytokine release syndrome

              All grades

81.2

85.7

73.6

              Grade ≥3

85

9.3

7.3

Neurotoxicity

              All grades

35.7

45.7

19.2

              Grade ≥3

9.7

14.5

1.6

Medically significant/opportunistic infection

31.7

31

32.6

Treatment, %

(n = 427)

(n = 280)

(n = 147)

Intensive care admission

32.6

36.4

25.2

Tocilizumab

65.1

69.3

57.2

Siltuximab

3

4.3

0.7

Corticosteroids

41.6

48.2

27.9

*Adapted from Le Gouill et al.1

Clinical outcomes

At a median follow-up of 6.5 months (range, 6.1−7.1), ORR was 60%, with 50.7% of patients in CR and 25% with PD. By 12 months, ORR was 68.7%, with 59.9% of patients in CR and 19.0% with PD.

Comparison of OS, PFS, and DOR at 6 months can be seen in Table 3. PFS in all patients with progressive disease at 6 months of treatment is reduced, with increased risk of early relapse.

Table 3. Clinical outcomes of patients with DLBCL in the DESCAR-T registry*

Outcome

CAR-T treated patients
% (range)

Untreated patients
% (range)

OS at 6 months

83.7 (79.7−86.9)

5.5 (1.1−15.6)

PFS at 6 months

(550 patients)

44.5 (39.6−49.2)

n/a

DOR at 6 months

(356 patients with response to treatment)

57.7 (51.6−63.3)

n/a

Outcome

Axi-cel treated patients

Tisa-cel treated patients

PFS at 6 months in patients in CR/PR/SD

61.4 (50−71)

52.5 (36.7−66

PFS at 6 months in patients with PD

38.2 (29.5−46.9)

17.1 (9.7−26.4)

OS at 6 months in patients in CR/PR/SD

87 (77−92.8)

88.2 (73.8−95)

PFS at 6 months in patients with PD

69.7 (60.5−77.1)

59.1 (47−69.3)

CR, complete remission; DOR, duration of response; n/a, not available; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial remission; SD, stable disease.
*Adapted from Le Gouill et al.1

Conclusion

The data from the DESCAR-T database/registry appears to support the work previously done in clinical trials, generating real-world evidence that CAR-T therapy is an effective routine treatment for patients with DLBCL. Data are similar between axi-cel and tisa-cel with no clear evidence of superiority. The registry did not find any evidence of novel toxicity patterns in patients receiving CAR-T cell therapy, adding to existing real-world evidence.

  1. Le Gouill S, Bachy E, Di Blasi R, et al. First results of DLBCL patients treated with CAR-T cells and enrolled in DESCAR-T registry, a French real-life database for CAR-T cells in hematologic malignancies. Oral presentation #S216. EHA2021; June 9, 2021; Virtual.

Understanding your specialty helps us to deliver the most relevant and engaging content.

Please spare a moment to share yours.

Please select or type your specialty

  Thank you

Newsletter

Subscribe to get the best content related to lymphoma & CLL delivered to your inbox