PS1066 AXICABTAGENE CILOLEUCEL (AXI‐CEL) IN REFRACTORY LARGE B CELL LYMPHOMA: OUTCOMES IN PATIENTS ≥ OR < 65 YEARS OF AGE IN THE PIVOTAL PHASE 1/2 ZUMA‐1 STUDY
Bibliographic record
Abstract
Background: Axi‐cel is an autologous anti‐CD19 chimeric antigen receptor (CAR) T cell therapy approved in the European Union and United States for the treatment of patients with relapsed or refractory large B cell lymphoma with ≥ 2 prior systemic therapies. In the 2‐year follow‐up of ZUMA‐1, the objective response rate was 83%, with a complete response rate of 58%, and 39% of patients were in ongoing response (Locke et al. Lancet Oncol . 2019). Aims: To assess efficacy and safety outcomes of axi‐cel in patients ≥ or <65 years of age from ZUMA‐1. Methods: Eligible patients with refractory large B cell lymphoma underwent leukapheresis and conditioning chemotherapy followed by a target dose of 2 × 10 6 anti‐CD19 CAR T cells/kg. The Phase 2 primary endpoint was investigator‐assessed objective response rate. Additional key endpoints were adverse events, overall survival, and levels of CAR gene‐marked cells in peripheral blood. Efficacy was evaluated for Phase 2 patients; safety was evaluated for all treated patients (Phases 1 and 2). Patients were analyzed by age ≥ 65 years vs <65 years. Results: As of August 11, 2018, 108 patients were treated. Patients ≥ 65 years (n = 27) vs <65 years (n = 81) had a median age of 69 years vs 55 years, respectively, and were 81% vs 63% male; 70% vs 36% had an International Prognostic Index score of 3–4, 59% vs 57% had an Eastern Cooperative Oncology Group performance status of 1, 67% vs 72% had ≥ 3 prior therapies, and median tumor burdens were 3790 mm 2 vs 3574 mm 2 . Median follow‐up was 27.1 months for Phase 2 patients (n = 101). The objective response rate for patients ≥ 65 years (n = 24) and <65 years (n = 77) was 92% and 81% (complete response rate, 75% and 53%), respectively, with ongoing responses in 42% and 38% of patients (ongoing complete response, 42% and 35%). The 24‐month overall survival rate was 54% for patients ≥ 65 years and 49% for patients <65 years. Most patients experienced Grade ≥ 3 adverse events (100% of patients ≥ 65 years; 98% of patients <65 years), and 4% of each group (1/27 patients ≥ 65 years and 3/81 patients <65 years) died due to adverse events as previously reported. Grade ≥ 3 neurologic events and cytokine release syndrome occurred in 44% vs 28% and 7% vs 12% of patients ≥ 65 years vs <65 years, respectively. CAR T cell expansion by peak level (43 vs 35 cells/μL) or area under the curve (562 vs 448 days × cells/μL) was similar in patients ≥ 65 years vs <65 years, respectively. Summary/Conclusion: The 2‐year follow‐up of ZUMA‐1 demonstrates that axi‐cel can induce high rates of durable responses with a manageable safety profile for patients ≥ and <65 years. Axi‐cel offers substantial clinical benefit for older patients with refractory large B cell lymphoma who otherwise have limited treatment options.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".