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A second LAG-3 blocker failed to beat pembrolizumab alone, a warning that the Opdualag result is not automatically a class effect.
Regeneron reported that the trial missed its primary PFS endpoint; the high-dose combination improved median PFS numerically by 5.1 months, but the difference was not statistically significant. Differences from RELATIVITY-047 include the comparator (pembrolizumab rather than nivolumab), the antibody, and dosing. The adjuvant fianlimab phase 3 continues.
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.
1,546 enrolled.
Not significant; primary endpoint not met
SourceNot significant
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival, fianlimab 1600 mg + cemiplimab vs pembrolizumabprimary | Fianlimab 1600 mg + cemiplimab | 508 | 11.5 months | 0.845 (0.709 to 1.008) | 0.0627 | link |
| Pembrolizumab | 462 | 6.4 months | ||||
| Progression-free survival, fianlimab 400 mg + cemiplimab vs pembrolizumabprimary | Fianlimab 400 mg + cemiplimab | 422 | 9.6 months | 0.931 (0.773 to 1.112) | 0.4661 | link |
| Pembrolizumab | 462 | 6.4 months | ||||
| Progression-free survival, cemiplimab monotherapy arm | Cemiplimab | 154 | 6.3 months | - | - | link |
Shares Caution: LAG-3 blockade outside active disease, Extended-interval immunotherapy: give checkpoint inhibitors every 8-12 weeks once stable, Give immunotherapy in the morning, Randomised trials of stopping immunotherapy after one year versus continuing and the tag failure.
Shares Melanoma, Pembrolizumab, Immune checkpoint inhibitors and the tag failure.
Shares Pembrolizumab, Immune checkpoint inhibitors and the tag failure.
Shares Pembrolizumab and the tag failure.
Shares Melanoma and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.
Shares Melanoma and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.