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

CAR T: IMPROVING SURVIVAL WITH THE SOC IN 2L LBCL1,a,b

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

How long has it been since my patient finished therapy?

CAR T-cell candidate?

YES

NO

>12 months

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

YES

CAR T ASCT

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

>3.5×

more patients with refractory or early-relapse LBCL may achieve potential cure with

CAR T vs. ASCT1–4

(based on calculations from extrapolating data from published sources)

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 (3L+ LBCL)5

Completion of intended therapy course4,6

Significant EFS improvement vs. comparator in ZUMA-7 or TRANSFORM4,6,7,b

Significant OS improvement comparator in ZUMA-7 or TRANSFORM7,8,b

Manageable safety profile4,6,9–20

Treatment eligibility considerations4,7,21,22

Significant QoL improvementb post treatment vs. comparator in ZUMA-7 or TRANSFORM23,24

Published 2L RWE in both the US and Europe14–20

5-year OS in the real world (n=275)

Received CAR T in ZUMA-7 (n=180)

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

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

N/A N/A 40%

94%

Axi-cel

No data

ZUMA-7 (n=179) TRANSFORM (n=92)

35%c 36%

mEFS and 2-year EFS in ZUMA-7

Received ASCT mOS/4-year OS in ZUMA-7

mEFS and 18-month EFS in TRANSFORM mOS/4-year OS in TRANSFORM 16%

Received CAR T in TRANSFORM (n=92)

mEFS and 18-month EFS in TRANSFORM, p<0.0001

mOS and 4-year OS 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

No chemosensitivity

CAR T is effective in a broader population than ASCT

Axi-cel (n=165) significantly improves 11/16 QoLf measures vs. ASCT (n=131) in ZUMA-7

85%c

Liso-cel

Older adults Comorbiditiese

ASCT was associated with a similar or longer return to baseline QoL vs. CAR T

Liso-cel (n=47) significantly improved 2/6 QoLg measures vs. ASCT (n=43) in TRANSFORM but the analysis was not prespecified

N/A

Rapid and reliable manufacture in the real world14,25,26 OOS rate

22%

36 days

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.

AXICABTAGENE CILOLEUCEL PRESCRIBING INFORMATION

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

GB Prescribing Information and AE reporting

References and footnotes

a CAR T therapies are not licensed for all types of R/R LBCL in the UK and EU. Please refer to individual prescribing information for full indications; b In ITT patients with refractory or early-relapse disease; c Patients with ongoing treatment/in the post–follow-up period/survival follow-up period. All patients underwent leukapheresis before randomisation; d Median overall survival was not significant in the primary analysis; e Patients with inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of adverse reactions and require special attention9,10; f QoL measures were assessed using EORTC QLQ-C30, EuroQol EQ-5D-5L or FACT-LymS;

g 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. In addition, patients in the SoC arm who did not respond to treatment could start the next line of therapy, after which HRQoL data were not collected; h For patients whose lots were released following first-pass manufacture. In this analysis, axi-cel demonstrated significantly shorter mV2Vt and significantly lower rates of OOS product vs. liso-cel (both p<0.001)

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/.

2L: second line; 3L: third line; AE: adverse event; ASCT: autologous stem cell transplant; axi-cel: axicabtagene ciloleucel; BR: bendamustine, rituximab; CAR: chimeric antigen receptor; chemo: chemotherapy; DLBCL: diffuse large B-cell lymphoma; EFS: event-free survival; EORTC: European Organisation for Research and Treatment of Cancer; FL: follicular lymphoma; HGBL: high-grade B-cell lymphoma; HRQoL: health-related quality of life; ITT: intention to treat; LBCL: large B-cell lymphoma; len: lenalidomide; liso-cel: lisocabtagene maraleucel; mEFS: median event-free survival; mOS: median overall survival; mos: months; mV2Vt: median vein-to-vein time; N/A: not applicable; NR: not reached; NS: not specified; OOS: out of specification; OS: overall survival; PI: Prescribing Information; PMBCL: primary mediastinal large B-cell lymphoma; pola: polatuzumab vedotin; QLQ-C30: Quality of Life Group Core Questionnaire; QoL: quality of life; R/R: relapsed/refractory; R-GemOx: rituximab, gemcitabine, oxaliplatin; RW: real world; RWE: real-world evidence; SoC: standard of care; tafa: tafasitamab

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

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. Spiegel JY, et al. ASH 2023 (Abstract 4864; oral).

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

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

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

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

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

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

13. 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).

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

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

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

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

18. Borchmann P, et al. Blood 2023; 142(suppl. 1):7387.

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

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

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

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

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

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

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

26. Alquist L, et al. TCT 2024 (Abstract 264; poster).

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• 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.

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