IMCgp100-202
The first drug ever to extend life in metastatic uveal melanoma, and the first T-cell receptor-based medicine to win a phase 3.
OS 21.7 vs 16.0 months (HR 0.51) despite a low response rate, showing that ctDNA reduction and tumour growth slowing matter more than RECIST shrinkage for this class. FDA approval January 2022. Cytokine release syndrome and rash are frequent but manageable with step-up dosing.
Setting
Untreated HLA-A*02:01-positive metastatic uveal melanoma: tebentafusp vs investigator's choice (pembrolizumab, ipilimumab, or dacarbazine)
Phase
Phase 3
Sponsor
Immunocore
Registry
Headline result
OS 21.7 vs 16.0 months; HR 0.51.
Reported
2021
Enrolled
378
Replication
Supported by a phase 2 in previously treated uveal melanoma; no second randomised trial.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 21.7 vs 16 months with Tebentafusp compared with Investigator's choice; about 5.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 49 percent lower chance of the event at any given time (hazard ratio 0.51).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Untreated HLA-A*02:01-positive metastatic uveal melanoma: tebentafusp vs investigator's choice (pembrolizumab, ipilimumab, or dacarbazine). 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.
378 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Tebentafusp | — | 21.7 months | 0.51 | — | link |
| Investigator's choice | — | 16 months |
Replication
Supported by a phase 2 in previously treated uveal melanoma; no second randomised trial.