CAR T: Improving Survival with the SOC in 2L LBCL

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CAR T: IMPROVING SURVIVAL WITH THE SOC IN 2L LBCL

CAR T or ASCT in 2L: Which therapy for my patient? Follow this simple algorithm… (adapted from Westin & Sehn Blood 2022)1

R/R LBCL

≤12 months

CAR T-cell candidate?

How long has it been since my patient finished therapy?

>12 months NO

Is my patient eligible for ASCT and do they have chemosensitive disease?

CAR T ASCT

Other 2L options; e.g. tafa-len, pola-BR

>3.5×

more patients with refractory or early-relapse LBCL may achieve potential cure with CAR T vs. ASCT1–4

Data from clinical trials and real-world evidence can support decision-making when choosing the appropriate therapy for your patient

5-year survival data in the RW setting

4-year OS in ZUMA-7

No data

94% Received CAR T in ZUMA-7

2-year EFS in ZUMA-7, p<0.001

4-year OS in ZUMA-7, p=0.03

Axi-cel significantly improved QoL vs. ASCT in ZUMA-7 (p<0.0001) Completion

Received ASCT in ZUMA-7 / TRANSFORM

5-year EFS in PARMA, p=0.001

5-year OS in PARMA, p=0.038

85%b Received CAR T in TRANSFORM

mEFS in TRANSFORM, p<0.0001

mOS in TRANSFORM, p=0.0987 (NS)

Clinical trial and RWE suggests the safety profiles of CAR T and ASCT are manageable using established guidelines and protocols

CAR T is effective in a broader population than ASCT

No chemosensitivity Advanced age Comorbidities

ASCT is associated with a similar or slower recovery of QoL vs. CAR T

362 patients intended for 2L axi-celg

Liso-cel was associated with a similar rate of recovery in QoLe vs. ASCT in TRANSFORMf

Many 2L datasets from around the world N/A

Data are from different clinical trials and CAR T products have not been compared in head-to-head studies; since there are inherent limitations in cross-study comparisons, caution should be exercised. This summary is for information purposes only and is not intended to imply or infer the noninferiority or superiority of CAR T products in terms of efficacy or safety profile.

© 2024 Gilead Sciences, Inc. All rights reserved. April 2024 | IHQ-UNB-5375
therapy
4,8 Significant EFS improvement4,8,9,a Significant OS improvement6,9,10,a Manageable safety profile11–15 Treatment eligibility48,16,17 Significant QoL improvementa 100 days post-treatment18–20 2L RWE in both the US and Europe20–27 Rapid and reliable manufacture in the real world26–28 MSR 96% mTAT 19 daysh ASCT LISOCABTAGENE MARALEUCEL
of intended
course
2L liso-cel OOS rate 36 days 22% V2Vt 46% 12% ASCT Chemo 41% 16% Axi-cel SoC 55% 46% Axi-cel SoC 53% 32% ASCT Chemo 36% 35% 2 mos SoC Liso-cel 10 mosc 30 mos ASCT Liso-cel NRd
17 patients intended for
YES
YES
AXICABTAGENE CILOLEUCEL N/A 55%
6,7
(3L+ LBCL)

AXICABTAGENE CILOLEUCEL PRESCRIBING INFORMATION

Please access the axicabtagene ciloleucel prescribing information by clicking the links below or scanning the QR codes

References and footnotes

Abbreviations

a In ITT patients with refractory or early relapse disease; b All patients underwent leukapheresis before randomisation; c 6.2 months median follow-up, median EFS for SoC was 2.4 months; d Median overall survival was not significant in the primary analysis; e Global health status/ QoL score calculated using EORTC QLQ-C30; f This study was limited by lower than anticipated questionnaire completion rates, with only 51% of patients in the liso-cel arm and 47% of patients in the SOC arm included in the HRQOL analyses;. g In addition, patients in the SoC arm who did not respond to treatment could start the next line of therapy, after which HRQOL data was not collected 16 days’ median turnaround time in the US for patients treated with axi-cel at 2L whose lots were released from first-pass manufacture

1. Westin JR & Sehn L. Blood 2022; 139:2737–2746

2. Sehn LH & Salles G. N Engl J Med 2021; 384:842–858.

GB Prescribing Information and AE reporting

PI

AE reporting

Adverse events should be reported. Healthcare professionals should report any adverse event via their national reporting system. In Great Britain and Northern Ireland, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or via the Yellow Card app. Adverse events should also be reported to Gilead to safety_FC@gilead.com or +44 (0) 1223 897500. For other countries, visit https://public.gsir.gilead.com/

3. Friedberg JW. Hematology Am Soc Hematol Educ Program 2011; 2011:498–505.

4. Locke FL, et al. N Engl J Med 2022; 386: 640–654.

5. Neelapu SS, et al. ASH 2023 (Abstract 4864; poster).

6. Westin JR, et al. N Engl J Med 2023; 389: 148–157.

7. Crump M, et al. J Clin Oncol 2014; 32:3490–3496.

8. Kamdar M, et al. Lancet 2022; 399:2294–2308.

9. Phillip T, et al. N Engl J Med 1995; 333:1540–1545.

10. Abramson JS, et al. Blood 2023; 141:1675–1684.

11. Axicabtagene ciloleucel SmPC (Feb 2024; available at www.ema.europa.eu).

12. Lisocabtagene maraleucel SmPC (Dec 2023; available at www.ema.europa.eu).

13. Santomasso BD, et al.J Clin Oncol 2021; 39: 3978–3992.

14. Hayden PJ, et al. Ann Oncol 2022; 33:259–275.

15. Carreras E, et al. The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies (2019; available at https://www. ebmt.org/sites/default/files/2019-01/2019_Book_TheEBMTHandbook.pdf).

16. Houot R, et al. Nat Med 2023; 29:2593–2601.

17. Sehgal A, et al. ASH 2023 (Abstract 105; oral).

18. Elsawy M, et al. Blood 2022; 140:2248–2260.

19. Fridberg G, et al. ASH 2023; (Abstract 4886; poster).

20. Abramson JS, et al. Blood Adv 2022; 6:5969–5979.

21. Brisou G, et al. ASH 2023 (Abstract 5138; poster).

22. Dahiya S, et al. ASH 2023; (Abstract 4876; poster).

23. Borchmann P, et al. Blood 2023; 142(Suppl. 1):7387.

24. Sawas A, et al. Blood 2020; 136(Suppl. 1):29–30.

25. Yagi Y, et al. Cancer Med 2023; 12:17808–17821.

26. Van de Wiel L, et al. EBMT 2023 (Abstract P198; poster).

27. Locke F, et al. EHA 2023 (Abstract P1204; poster).

28. Portuguese AJ et al. TCT 2024; (Abstract 249; poster).

This educational material is intended for healthcare professionals only and is fully funded by Kite, a Gilead Company, through Gilead Sciences Europe Ltd, and contains promotional content.

• Axicabtagene ciloleucel is indicated for the treatment of adult patients with R/R DLBCL and PMBCL, after two or more lines of systemic therapy

• Axicabtagene ciloleucel is indicated for the treatment of adult patients with DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy

• Axicabtagene ciloleucel is indicated for the treatment of adult patients with R/R FL after three or more lines of systemic therapy

This medicinal product is subject to additional monitoring.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. KITE and the KITE logo are trademarks of Kite Pharma, Inc. © 2024 Gilead Sciences, Inc. All rights reserved.

To learn more from experts in cell therapy and access our medical education resources on demand, visit CellTherapyHub.com or scan the QR code to find out more!

© 2024 Gilead Sciences, Inc. All rights reserved. April 2024 | IHQ-UNB-5375
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