MajesTEC-1
MajesTEC-1 was the pivotal single-arm study for the first myeloma bispecific, with responses in 63% of patients who had exhausted the main drug classes.
ORR 63%, CR or better 39%; median PFS 11.3 months, median OS 22.2 months at 30-month follow-up. Infections were the leading cause of non-relapse death, prompting IVIG prophylaxis.
Setting
Relapsed/refractory myeloma after ≥3 lines: teclistamab monotherapy
Phase
Phase 1/2
Sponsor
Janssen
Registry
Headline result
ORR 63%, ≥CR 39%.
Reported
2022
Enrolled
165
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 63 out of 100 people had their tumour shrink with Teclistamab.
- 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: teclistamab monotherapy. 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.