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Extended adjuvant immunotherapy to thick node-negative melanomas, a group whose risk of relapse rivals stage III.
RFS and distant metastasis-free survival improved (FDA approval December 2021 for stage IIB/IIC). Five-year follow-up (ESMO 2025) reported sustained RFS and DMFS benefit; OS not yet mature. The absolute benefit is smaller than in stage III and the trial reignited debate about over-treatment given that most stage II patients never relapse.
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.
976 enrolled.
Median not reached in either arm; HR 0.61 (95% CI 0.45-0.82) at the second interim analysis
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Recurrence-free survival (first interim analysis)primary | Pembrolizumab | 487 | Median not reached in either arm; HR 0.61 (95% CI 0.45-0.82) at the second interim analysis | 0.65 (0.46 to 0.92) | 0.0066 | link |
| Placebo | 489 | - | ||||
| Distant metastasis-free survival at 36 months (final DMFS analysis) | Pembrolizumab | - | 84.4% | 0.59 (0.44 to 0.79) | - | link |
| Placebo | - | 74.7% | ||||
| Recurrence-free survival at 36 months | Pembrolizumab | - | 76.2% | 0.62 (0.49 to 0.79) | - | link |
| Placebo | - | 63.4% | ||||
| Recurrence-free survival at 48 months | Pembrolizumab | - | 71.3% | 0.62 (0.5 to 0.78) | - | link |
| Placebo | - | 58.3% |
Adjuvant pembrolizumab is approved for stage IIB and IIC melanoma, though the absolute benefit and lack of survival data make observation a reasonable alternative after discussion.
A second publication from the KEYNOTE-716 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
Shares Stage IIB and IIC melanoma, Melanoma, Immune checkpoint inhibitors.
Shares Stage IIB and IIC melanoma, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Melanoma, Pembrolizumab.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors.
Shares Stage IIB and IIC melanoma, Melanoma.
Shares Stage IIB and IIC melanoma, Melanoma.
Shares Stage IIB and IIC melanoma, Melanoma.
Shares Stage IIB and IIC melanoma, Melanoma.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pembrolizumab, Immune checkpoint inhibitors.