LINKER-MM1
LINKER-MM1 is the pivotal study for linvoseltamab, with 45% complete responses.
ORR 70%, ≥CR 45%; median PFS not reached at 14 months. Basis for July 2025 accelerated approval.
Setting
Relapsed/refractory myeloma after ≥3 lines: linvoseltamab 200 mg
Phase
Phase 1/2
Sponsor
Regeneron
Registry
Headline result
ORR 70%, ≥CR 45%.
Reported
2024
Enrolled
117
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 70 out of 100 people had their tumour shrink with Linvoseltamab 200 mg.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Relapsed/refractory myeloma after ≥3 lines: linvoseltamab 200 mg. People in a different situation may not see the same effect.
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.
117 participants enrolled.
Objective response rateprimary
Linvoseltamab 200 mg70 of 100
n = 117
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Linvoseltamab 200 mg | 117 | 70% | — | — | — |