CheckMate 498
CheckMate 498 asked whether nivolumab could replace temozolomide in the glioblastoma patients who gain least from it. Patients given nivolumab lived a shorter time.
Overview
CheckMate 498, trial NCT02617589 sponsored by BMS, randomised 560 patients with newly diagnosed glioblastoma and an unmethylated MGMT promoter to standard radiotherapy (60 Gy) with nivolumab or with temozolomide. Median overall survival, the primary endpoint, was 13.4 months with nivolumab and 14.9 months with temozolomide (HR 1.31, 95% CI 1.09-1.58); median progression-free survival was 6.0 versus 6.2 months. Published by Omuro and colleagues in Neuro-Oncology (2023;25:123-134). It is one of three negative phase 3 trials of nivolumab in glioblastoma, with CheckMate 143 at recurrence and CheckMate 548 in MGMT-methylated disease.
- Median 13.4 vs 14.9 months with Nivolumab + RT compared with Temozolomide + RT; about 1.5 months shorter 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 31 percent higher chance of the event at any given time (hazard ratio 1.31, likely range 1.09 to 1.58).
- 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: Newly diagnosed glioblastoma with unmethylated MGMT promoter: radiotherapy + nivolumab vs radiotherapy + temozolomide. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (MGMT); the result should not be assumed for people whose cancer does not have it.
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.
560 participants enrolled.
Favours temozolomide
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, MGMT-unmethylated glioblastomaprimary | Nivolumab + RT | 280 | 13.4 months | 1.31 (1.09 to 1.58) | 0.0037 | link |
| Temozolomide + RT | 280 | 14.9 months |
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