Assessing whether the patient is eligible and suitable for CAR-T treatment with YESCARTA^®

Referring hospital: haematologist and oncologist

YESCARTA^® (axicabtagene ciloleucel) is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.¹

YESCARTA^® is a type of immunotherapy. It involves a patient’s T cells being harvested, genetically modified in the lab to attack cells carrying CD19, and infused back into the same patient.¹

For more information on how YESCARTA^® works as well as its efficacy and safety, see About YESCARTA^®.

YESCARTA^® is accepted by PALKO in Finland. Approved at the meeting of the Council for Choices in Health Care (COHERE) on 12 December 2019: Axicabtagene ciloleucel (YESCARTA) is included in Finland’s national range of public health services for the treatment of adult patients with good condition (WHO 0-1) and relapsed or refractory diffuse large B‑cell lymphoma and primary mediastinal large B‑cell lymphoma after two or more lines of systemic therapy, but only if the conditions set out in this recommendation are met.²

Here, we address suitability of patients for therapy based on clinical eligibility only. See the next section for information on patient access in Finland.

An adult with DLBCL or PMBCL may be eligible for YESCARTA^® treatment if he or she meets one of these three criteria:^1,3

1. Has relapsed or refractory disease after receiving two or more lines of chemotherapy¹
2. Has had first-line chemotherapy and relapsed ≤12 months after second-line chemotherapy with autologous stem cell transplant¹
3. Has received first-line chemotherapy and was eligible for autologous stem cell transplant but failed pre-ASCT transplant salvage therapy¹

Additional eligibility considerations based on the protocol for the Phase 2 clinical trial of YESCARTA^® in large B cell lymphoma (ZUMA-1) are shown in the table.

Consideration should also be given to prior therapies the patient has received and any ongoing toxicities, as these may affect the collection of adequate T cells required to make YESCARTA^®.^3–5

Table: Eligibility for YESCARTA^® based on performance status, organ function, and infection. ALT = alanine aminotransferase; AST = aspartate transaminase; ULN = upper limited of normal. Information based on the protocol for: Neelapu SS, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017;377:2531-44.³

In Finland criteria for CAR-T treatment correspond to the ZUMA-1 criteria.

Informing the patient about CAR-T treatment with YESCARTA^® and managing expectations before referral

Haematologist or oncologist

Although potentially eligible patients will be treatment-experienced, the CAR-T treatment process is distinct to that of other lymphoma treatments the patient will have received. As well as explaining how the treatment works and the potential benefits and risks, the referring physician should ensure that the patient:

• appreciates that there are multiple steps in the treatment process¹
• understands that there will be a wait of about 4 weeks between the collection of their T cells and administration of YESCARTA^®1
• accepts that there is a high risk of potentially serious side effects including cytokine release syndrome (CRS) and neurological adverse reactions¹
• is able to meet the requirements of therapy, including staying near the treating hospital for 4 weeks after infusion¹
• is amenable to long-term follow up.³

References

1. KITE Pharma EU B.V. Yescarta 0.4 – 2 x 10⁸ cells dispersion for infusion. Summary of product characteristics. June 2022. 
2. Medicinrådet. Baggrund for Medicinrådets anbefaling vedrørende axicabtagene ciloleucel som mulig standardbehandling til diffust storcellet B-celle-lymfom. Dokumentnummer 48426, versionsnummer 1.0. 15 May 2019.
3. Protocol for Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med 2017;377:2531-44.
4. Jain T, et al. Use of chimeric antigen receptor T cell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant 2019;25:2305-21.
5. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology (NCCN Guidelines^®): B-cell lymphomas, Version 2.2021. 16 February 2021.

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