Sample benchmark sheet · Oncology
Relapsed or refractory DLBCL: complete response in single-arm trials
What published trials showed in this setting. This is precedent, not an FDA requirement.
- Indication
- Diffuse Large B-Cell Lymphoma
- Endpoint
- Complete response rate (CR)
- Setting
- Relapsed or refractory, after prior systemic therapy
- Checked
- 2 November 2026
Lowest approved precedent
24.1%
Complete response rate, with no control arm
LOTIS-2 (loncastuximab tesirine): 35 of 145 patients
The weakest result among the approved trials on this sheet. Approved precedents listed here showed CR of 24.1% (loncastuximab, LOTIS-2), 40% (JULIET), 43% (L-MIND) and 54% (ZUMA-1). FDA labels report lower rates for some: JULIET 32%, L-MIND 37%, ZUMA-1 51%. Observed precedent, not an FDA bar.
The trials
Each of these trials supported an FDA approval.
| Trial | Result | Sources |
|---|---|---|
| ZUMA-1axicabtagene ciloleucel, CAR-T | 54% CR, 82% ORRFigures from: Paper abstract | Neelapu et al., NEJM 2017 Yescarta FDA label |
| JULIETtisagenlecleucel, CAR-T | 40% CR, 52% ORRFigures from: Paper abstract | Schuster et al., NEJM 2019 Kymriah FDA label |
| L-MINDtafasitamab+lenalidomide; 1-3 prior regimens, transplant-ineligible | 60% ORR, 43% CR (Salles 2020); FDA label 55% and 37%Figures from: Paper abstract and FDA label | Salles et al., Lancet Oncol 2020 Monjuvi FDA label |
| LOTIS-2loncastuximab tesirine, after 2 or more prior regimens | 24.1% CR, 48.3% ORRFigures from: Paper abstract and FDA label | Caimi et al., Lancet Oncol 2021 Zynlonta FDA label |
CR: complete response. ORR: overall response rate.
Observed range: 24.1% to 54%, median 41.5%. Based on the 4 named trials listed. Range and median use CR rates from the papers; FDA labels report lower rates for some, as the limits below say.
The limits of this sheet
- These are single-arm results, so there is no control arm to measure a gain against.
- Complete response was not what these approvals turned on. ZUMA-1 and JULIET used overall response as the primary endpoint, and the accelerated approvals of tafasitamab and loncastuximab rested on overall response.
- FDA labels report lower complete response rates for some: 51% for ZUMA-1, 32% for JULIET and 37% for L-MIND. The lowest precedent is 24.1% either way.
- L-MIND enrolled patients after one to three prior regimens, so part of it is second line.
- The drugs differ: two CAR-T therapies, an antibody combination and an antibody-drug conjugate.
- Response criteria differ, for example 2007 IWG in L-MIND and Lugano 2014 in LOTIS-2.
- This is precedent, not a requirement. These results supported approvals in their own context, and matching a number here guarantees nothing.
- This is a selected list. Only the trials named here are counted, and other approvals in this setting are not on this sheet.
- Results across trials are not directly comparable. Populations, control arms, follow-up and response criteria differ.
FDA context
Accelerated approval on overall response: tafasitamab+lenalidomide 7/31/2020 and loncastuximab 4/23/2021 (fda.gov). The axi-cel and tisagenlecleucel labels carry an accelerated-approval statement only for follicular lymphoma, not for large B-cell lymphoma.
Also cited on this row
How this was checked
On 2 November 2026 automated tools checked each result against the source named beside it and resolved each paper’s DOI. No clinician has reviewed this sheet. Check the source before you rely on a figure. Tell us if something looks wrong.
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