Sample benchmark sheet · Oncology
Heavily pretreated multiple myeloma: ORR in single-arm trials
What published trials showed in this setting. This is precedent, not an FDA requirement.
- Indication
- Multiple Myeloma
- Endpoint
- Overall response rate (ORR)
- Setting
- Relapsed or refractory, heavily pretreated
- Checked
- 2 November 2026
Lowest approved precedent
25.3%
Overall response rate, with no control arm
STORM (selinexor + dexamethasone), FDA label: 21 of 83 patients, median duration of response 3.8 months
The weakest result among the approved trials on this sheet. Approved precedents listed here showed ORR of 25.3% (selinexor+dexamethasone, STORM, n=83, median DoR 3.8 months), 61.0% (elranatamab), 64% to 70% (talquetamab) and 73% (ide-cel). Observed precedent, not an FDA bar.
The trials
Each of these trials supported an FDA approval.
| Trial | Result | Sources |
|---|---|---|
| MagnetisMM-3elranatamab, BCMA bispecific | 61.0% (75/123)Figures from: Paper abstract | Lesokhin et al., Nat Med 2023 Elrexfio FDA label |
| MonumenTAL-1talquetamab, GPRC5D | 70% (405 µg/kg weekly), 64% (800 µg/kg every 2 weeks); FDA label 73% and 73.6%Figures from: Paper abstract and FDA label | Chari et al., NEJM 2022 Talvey FDA label |
| KarMMaidecabtagene vicleucel, CAR-T | 73% (94/128)Figures from: Paper abstract | Munshi et al., NEJM 2021 |
| STORMselinexor+dexamethasone, penta-refractory | 25.3% (21/83), median DoR 3.8m (FDA label)Figures from: FDA label | Chari et al., NEJM 2019 Xpovio FDA label |
Results are overall response rates. DoR: duration of response.
Observed range: 25.3% to 73%, median 65.5%. Based on the 4 named trials listed. Range and median use each trial's lead figure (70% for talquetamab weekly).
The limits of this sheet
- These are single-arm results, so there is no control arm to measure a gain against.
- The lowest precedent is far from the rest. STORM's patients had a median of 7 prior regimens, and its 2019 approval came before the CAR-T and bispecific approvals listed here. It says little about what a new drug in those classes would face.
- The drug classes differ: a CAR-T therapy, bispecific antibodies and a nuclear export inhibitor.
- Papers and labels differ. Selinexor is 26% of 122 patients in the paper and 25.3% of 83 on the label. Elranatamab is 61.0% of 123 in the paper and 57.7% of 97 on the label.
- The talquetamab paper reports the Phase 1 study (70% and 64%). The label's 73% and 73.6% come from MonumenTAL-1 groups of 100 and 87 patients.
- Elranatamab and talquetamab are still on FDA's accelerated approval list.
- 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
FDA has approved therapies for heavily pretreated RRMM on response rate and durability from single-arm studies: accelerated approval for selinexor 7/3/2019 (traditional 12/18/2020), elranatamab 8/14/2023 and talquetamab 8/9/2023. Ide-cel's label carries no accelerated-approval statement. No minimum DoR is published: selinexor's median DoR was 3.8 months. FDA lists: fda.gov and fda.gov.
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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