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ZUMA-5 showed that a single infusion of CD19 CAR-T cells put most people with heavily pretreated follicular lymphoma into remission, and that many of those remissions have lasted for years.
ZUMA-5 was a single-arm phase 2 study of axicabtagene ciloleucel, an autologous CD19-directed CAR-T product, in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma after at least two prior lines including an anti-CD20 antibody and an alkylating agent. The primary endpoint was objective response rate by independent review.
The great majority of patients with follicular lymphoma responded and most of those responses were complete; with long follow-up roughly half remained progression-free at four years, and cytokine release syndrome and neurological events were mostly manageable. Axicabtagene ciloleucel received accelerated approval in the United States for follicular lymphoma in March 2021, the first CAR-T for an indolent lymphoma.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
159 enrolled.
95% CI 85 to 97; median follow-up 17.5 months; 84 follicular and 20 marginal zone lymphoma
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall response rate (independent review, primary analysis)primary | Axicabtagene ciloleucel | 104 | 92% | - | - | link |
| Complete response (primary analysis) | Axicabtagene ciloleucel | 104 | 74% | - | - | link |
| Grade 3 or worse cytokine release syndrome | Axicabtagene ciloleucel | 148 | 7% | - | - | link |
| Grade 3-4 neurological events | Axicabtagene ciloleucel | 148 | 19% | - | - | link |
Axicabtagene ciloleucel as an option in relapsed follicular and marginal zone lymphoma. Compared with tisagenlecleucel in ELARA, the response rates are higher and the neurological toxicity substantially greater, which is the trade-off a patient and centre weigh.
Chemotherapy-free cellular therapy for follicular lymphoma that has stopped responding, with a toxicity profile mild enough that the treatment is deliverable outside the largest centres.
The single most used prognostic marker in follicular lymphoma, and the reason a relapse at 20 months is handled differently from one at 30 months. It is now a standard stratification factor and a standard eligibility criterion in trials of the disease.
Shares Cytokine release syndrome and ICANS: grading and management, Axicabtagene ciloleucel, Gilead Sciences (incl. Kite), Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag subtype-trials.
Shares Cytokine release syndrome and ICANS: grading and management, Gilead Sciences (incl. Kite), CAR-T cell therapy, Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares POD24: progression of follicular lymphoma within two years, and why it changes the plan, Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), Marginal zone lymphoma, Follicular lymphoma and the tag subtype-trials.
Shares Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag subtype-trials.
Shares ELARA, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management, Axicabtagene ciloleucel.
Shares Axicabtagene ciloleucel, Gilead Sciences (incl. Kite), Follicular lymphoma, CAR-T cell therapy.