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ZUMA-1 was the trial that brought CAR-T cell therapy to large B-cell lymphoma: a single infusion produced remissions in most patients whose disease had resisted chemotherapy, and about four in ten stayed in remission for years.
ZUMA-1 was the pivotal phase 1/2 study of axicabtagene ciloleucel (KTE-C19), a CD19-directed CAR-T, in patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or transformed follicular lymphoma that was refractory to the last chemotherapy or had relapsed within a year of autologous transplant. Patients received lymphodepleting fludarabine and cyclophosphamide and a single infusion; the primary endpoint was objective response rate.
Most patients responded and more than half achieved a complete response, a striking result in a population whose expected response to salvage chemotherapy was poor, and a large minority remained in durable remission at five years. Cytokine release syndrome and neurological toxicity were frequent but mostly reversible. The product was approved in the United States in October 2017, the first CAR-T for lymphoma, and ZUMA-7 later moved it into second line.
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.
307 enrolled.
Median follow-up 15.4 months; 111 enrolled, 101 treated
Source40% in ongoing complete response
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Axicabtagene ciloleucel | 101 | 82% | - | - | link |
| Complete response rate | Axicabtagene ciloleucel | 101 | 54% | - | - | link |
| Ongoing response at median follow-up of 15.4 months | Axicabtagene ciloleucel | 101 | 42% | - | - | link |
| Overall survival at 18 months | Axicabtagene ciloleucel | 101 | 52% | - | - | link |
| Grade 3 or higher cytokine release syndrome | Axicabtagene ciloleucel | 101 | 13% | - | - | link |
| Grade 3 or higher neurologic events | Axicabtagene ciloleucel | 101 | 28% | - | - | link |
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 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, Cyclophosphamide, Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Cyclophosphamide 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 Non-Hodgkin lymphoma (all types) and the tag subtype-trials.
Shares Cyclophosphamide and the tag subtype-trials.