Patient Eligibility for CAR T | CAR T Hope

PATIENT IDENTIFICATION

Patient identification for CAR T is largely dependent on primary oncologists

  • Over 50% of all US patients battling cancer are treated in community practices1
  • Perceived barriers for CAR T use include2-4:

Older patient age

Safety concerns

Comorbidities

Administrative/logistical challenges

  • A majority of oncologists reported that 50% or less of their patients referred for CAR T treatment received it5*
    • Patients may progress before receiving CAR T and become ineligible for treatment. Often patients have moved onto subsequent lines of therapy and their disease may progress rapidly, underscoring their immediate need for treatment2,6

You have an essential role throughout the CAR T journey

Find out who is eligible for CAR T

Improve the rate of successful referral through early identification of appropriate patients for CAR T

Who is eligible for CAR T therapy?

Current criteria for receiving CAR T are less strict than those of the pivotal trials.4,7,8

  • As many as 56% of patients observed in real-world studies would not have been able to participate in clinical trials due to comorbidities7-11
  • Many appropriate patients for CAR T, who were ineligible for clinical trials, are now being referred to treatment centers4

Patients should be selected based on their medical history and physical condition.4,12

Other factors to consider when referring a patient for CAR T include†:

  • Age
  • ECOG performance status
  • Organ function
  • Bone marrow reserve
  • History of active malignancy
  • Presence of CNS involvement
  • Existing or suspected infection
  • Major cardiac conditions
  • Pulmonary function
  • Prior transplant

Patients with aggressive R/R B-cell NHLs are historically associated with a poor prognosis and should be evaluated promptly for CAR T eligibility.13,14

Evaluating patients with hematologic cancers for CAR T eligibility upon treatment failure may help accelerate the time to treatment initiation.6,14,15

More of your patients may be eligible to receive CAR T therapy than you think. Consult with a CAR T treater upon treatment failure for timely assessment.

CAR T Experience

22,000+ patients with certain hematologic cancers have been treated with CAR T therapy globally16,17

A broader range of patients than those studied in clinical trials may benefit from CAR T therapy7,8,15,18,19

  • Real-world evidence was generally consistent with the efficacy and safety results seen in clinical trials7,8,15,18,19
  • Some patients who received CAR T in real-world studies had an ECOG performance status ≥220
  • Stem cell transplant has general age guidelines (<65 years of age), while CAR T does not, enabling greater eligibility for patients to receive CAR T therapy4,21
    • Patients who received CAR T in real-world studies ranged from 14 to 91 years of age7,9,18,22,23

Outcomes in patients ≥65 years and <65 years of age from clinical trial and real-world evidence24-26‡

ORR CR
≥65 years <65 years ≥65 years <65 years
LBCL 59-92% 49-81% 51-75% 48-53%
FL§ 90% 94% 79% 71%
ALL NA 100% 71%
MM|| 70%-97% 90% NA
ORR CR
≥65 years <65 years ≥65 years <65 years
LBCL 59-92% 49-81% 51-75% 48-53%
FL§ 90% 94% 79% 71%
ALL NA 100% 71%
MM|| 70%-97% 90% NA

Common adverse events associated with CAR T therapy are CRS and neurotoxicity. Some side effects can be severe. Please refer to the safety section for additional information.14

Impact of Wait Times

Start the CAR T referral process once you have identified a potential patient6,27

Wait time management is an important factor to consider, particularly in patients with hematologic malignancies who have a poor prognosis. Promptly refer eligible patients to CAR T treatment centers to avoid potential treatment delays and other unfavorable outcomes.6,13,14,27

Wait times can impact patient mortality28

A discrete event simulation model was developed to project the potential impact of wait times on CAR T therapy for patients with R/R DLBCL.

  • It simulated a patient population from a clinical trial who had received chemotherapy and assumed that they followed established OS and PFS chemotherapy curves
  • 9 hypothetical wait times (1 to 9 months) in addition to a 2-3 week CAR T manufacturing time were used
  • The outcome was all-cause mortality set to 1 year
  • Limitations include the single-arm nature of trials used and the lack of randomized trials for parallel two-arm comparison between CAR T therapy and chemotherapy
    • In this analysis, it was assumed patients would immediately receive chemotherapy during the delay of treatment, therefore the impact on wait times could be underestimated or overestimated
  • The model design affects the generalizability of these findings and should not be used to guide individual patient decisions

Increase in all-cause 1-year mortality rate relative to the baseline 1-year mortality rate of 34.0%28

All-cause 1-year mortality according to scenario and treatment Mortality rate scale is 0-80%. Baseline case (no wait) is 34.0% 1-month wait is 36.1% 2-month wait is 38.8% Chemotherapy is 75.1% 14% increase in mortality rate with a 2-month delay in CAR T treatment initiation

Prolonging the wait time for CAR T therapy from 1 to 9 months increased the predicted 1-year mortality rate from 36.1% to 76.3%.28

The magnitude of survival decreases as wait time for treatment increases28

Results of this simulation model suggest that receiving CAR T therapy as soon as possible can give HCPs and patients more confidence in potentially reducing mortality risk.

Survival rates could decrease as the wait times for CAR T therapy increase.28

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*In preceding 6 months. Based on a 2021 Cardinal Health survey of 154 oncologists.5

†This is not a comprehensive or definitive list of eligibility criteria for CAR T referral. Patient selection should be based on the individual and can vary among CAR T centers.

‡Based on a review of 9 clinical and real-world studies of approved CAR T products in patients with DLBCL, MCL, MM, FL, and ALL.24

§Based on available subgroup data from a single-arm, phase 2 clinical trial that evaluated ORR and CR (n=104) in adult patients with R/R indolent NHL.25,29

||Includes subgroup data from a single-arm, phase 1b/2 clinical trial that evaluated ORR in 35 patients aged ≥65 years with R/R MM.26

6.2% increase in all-cause 1-year mortality rate from baseline.28

#121% increase in all-cause 1-year mortality rate from baseline.28

ALL=acute lymphoblastic lymphoma; CAR T=chimeric antigen receptor T cell; CNS=central nervous system; CR=complete remission; CRS=cytokine release syndrome; DLBCL=diffuse large B-cell lymphoma; ECOG=Eastern Cooperative Oncology Group; FL=follicular lymphoma; HCP=healthcare provider; LBCL=large B-cell lymphoma; MCL=mantle cell lymphoma; MM=multiple myeloma; NA=not available; NHL=non-Hodgkin lymphoma; ORR=overall response rate; PFS=progression-free survival; R/R=relapsed/refractory.

References

1. Gajra A, Jeune-Smith Y, Feinberg BA. Barriers to referral for chimeric antigen receptor T cell (CAR-T) therapies among U.S. community hematologists/oncologists (cH/O). Blood. 2021;138(suppl 1):4010-4011. 2. Gajra A, Zalenski A, Sannareddy A, Jeune-Smith Y, Kapinos K, Kansagra A. Barriers to chimeric antigen receptor T-cell (CAR-T) therapies in clinical practice. Pharmaceut Med. 2022;36(3):163-171. 3. Gajra A, Jeune-Smith Y, Kish J, Yeh T-C, Hime S, Feinberg BA. Perceptions of community hematologists/oncologists on barriers to chimeric antigen receptor T-cell therapy for the treatment of diffuse large B-cell lymphoma. Immunotherapy. 2020;12(10):725-732. 4. Hayden PJ, Sirait T, Koster L, Snowden JA, Yakoub-Agha I. An international survey on the management of patients receiving CAR T-cell therapy for haematological malignancies on behalf of the Chronic Malignancies Working Party of EBMT. Curr Res Transl Med. 2019;67(3):79-88. 5. Oncology Insights: June 2021. Cardinal Health; 2021. Accessed February 22, 2023. https://www.cardinalhealth.com/content/dam/corp/web/documents/publication/cardinal-health-oncology-insights-june-2021.pdf 6. Jacobson CA, Farooq U, Ghobadi A. Axicabtagene ciloleucel, an anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory large B-cell lymphoma: practical implications for the community oncologist. Oncologist. 2020;25(1):e138-e146. 7. Landsburg DJ, Frigault MJ, Hu Z-H, et al. Real-world efficacy and safety outcomes for patients with relapsed or refractory (R/R) aggressive B-cell non-Hodgkin’s lymphoma (aBNHL) treated with commercial tisagenlecleucel: update from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry. Presented at: 63rd ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Presentation 429. 8. Jacobson CA, Locke FL, Ma L, et al. Real-world evidence of axicabtagene ciloleucel for the treatment of large B cell lymphoma in the United States. Transplant Cell Ther. 2022;28(9):581.e1-581.e8. 9. Nastoupil LJ, Jain MD, Feng L, et al. Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma: results from the US Lymphoma CAR T Consortium. J Clin Oncol. 2020;38(27):3119-3128. 10. Kilgore KM, Mohammadi I, Schroeder A, Teigland C, Purdum A, Shah GL. Medicare patients receiving chimeric antigen receptor T-cell therapy: a first real-world look at patient characteristics, healthcare utilization & costs. Presented at: 61st ASH Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. 11. Hansen DK, Sidana S, Peres L, et al. Idecabtagene vicleucel (ide-cel) chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory multiple myeloma (RRMM): real-world experience. Presented at: 2022 ASCO Annual Meeting; June 3-7, 2022; Chicago, IL. Abstract 8042. 12. Granroth G, Rosenthal A, McCallen M, et al. Supportive care for patients with lymphoma undergoing CAR-T-cell therapy: the advanced practice provider’s perspective. Curr Oncol Rep. 2022;24(12):1863-1872. 13. St-Pierre F, Gordon LI. CAR T-cell therapy for relapsed/refractory non-Hodgkin’s lymphoma: a comprehensive review. Clin Adv Hematol Oncol. 2022;20(5):309-318. 14. Beaupierre A, Kahle N, Lundberg R, Patterson A. Educating multidisciplinary care teams, patients, and caregivers on CAR T-cell therapy. J Adv Pract Oncol. 2019;10(suppl 3):29-40. 15. Amini L, Silbert SK, Maude SL, et al. Preparing for CAR T cell therapy: patient selection, bridging therapies and lymphodepletion. Nat Rev Clin Oncol. 2022;19(5):342-355. 16. Data on file [1]. Kite Pharma, Inc; 2022. 17. Data on file [2]. Kite Pharma, Inc; 2022. 18. Iacoboni G, Rejeski K, Villacampa G, et al. Real-world evidence of brexucabtagene autoleucel for the treatment of relapsed or refractory mantle cell lymphoma. Blood Adv. 2022;6(12):3606-3610. 19. Pasquini MC, Hu Z-H, Curran K, et al. Real-world evidence of tisagenlecleucel for pediatric acute lymphoblastic leukemia and non-Hodgkin lymphoma. Blood Adv. 2020;4(21):5414-5424. 20. Vic S, Lemoine J, Armand P, Lemonnier F, Houot R. Transplant-ineligible but chimeric antigen receptor T-cells eligible: a real and relevant population. Eur J Cancer. 2022;175:246-253. 21. Tay J, Daly A, Jamani K, et al. Patient eligibility for hematopoietic stem cell transplantation: a review of patient-associated variables. Bone Marrow Transplant. 2019;54(3):368-382. 22. Iacoboni G, Villacampa G, Martinez-Cibrian N, et al; GETH, GELTAMO Spanish Groups. Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. Cancer Med. 2021;10(10):3214-3223. 23. Jacobson CA, Hunter BD, Redd R, et al. Axicabtagene ciloleucel in the non-trial setting: outcomes and correlates of response, resistance, and toxicity. J Clin Oncol. 2020;38(27):3095-3106. 24. Shouse G, Danilov AV, Artz A. CAR T-cell therapy in the older person: indications and risks. Curr Oncol Rep. 2022;24(9):1189-1199. 25. Jacobson CA, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1)(suppl):91-103. doi:10.1016/S1470-2045(21)00591-X 26. Jakubowiak A, Usmani SZ, Berdeja JG, et al. Efficacy and safety of ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE-1 subgroup analysis. Blood. 2021;138:3938-3940. 27. Santomasso B, Bachier C, Westin J, Rezvani K, Shpall EJ. The other side of CAR T-cell therapy: cytokine release syndrome, neurologic toxicity, and financial burden. Am Soc Clin Oncol Educ Book. 2019;39:433-444. 28. Tully S, Feng Z, Grindrod K, McFarlane T, Chan KKW, Wong WWL. Impact of increasing wait times on overall mortality of chimeric antigen receptor T-cell therapy in large B-cell lymphoma: a discrete event simulation model. JCO Clin Cancer Inform. 2019;3:1-9. 29. Jacobson CA, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1):91-103.