MonumenTAL-1
Showed that a second target, GPRC5D, works in myeloma, including after BCMA therapies have failed.
ORR 74% (0.4 mg/kg weekly) and 72% (0.8 mg/kg every 2 weeks); 65% in prior T-cell-redirection cohort. Taste, skin and nail toxicities frequent.
Setting
Relapsed/refractory myeloma after ≥3 lines: talquetamab (weekly or biweekly)
Phase
Phase 1/2
Sponsor
Janssen
Registry
Headline result
ORR ~73%.
Reported
2022
Enrolled
288
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 71.7 vs 74.1 out of 100 had their tumour shrink with Talquetamab 0.8 mg/kg Q2W compared with Talquetamab 0.4 mg/kg QW; 2.4 fewer per 100.
- On this measure the first group did worse, not better.
- 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: talquetamab (weekly or biweekly). 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.
288 participants enrolled.
Objective response rateprimary
Talquetamab 0.8 mg/kg Q2W71.7 of 100
n = 145
Talquetamab 0.4 mg/kg QW74.1 of 100
n = 143
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | Talquetamab 0.8 mg/kg Q2W | 145 | 71.7% | — | — | — |
| Talquetamab 0.4 mg/kg QW | 143 | 74.1% |