LUME-Meso
In LUME-Meso, a promising phase 2 signal for the multi-kinase inhibitor nintedanib vanished in phase 3.
PFS 6.8 vs 7.0 months (HR 1.01); no OS benefit. A lesson in the unreliability of small randomised phase 2 PFS signals in mesothelioma.
Setting
Epithelioid pleural mesothelioma, first line: cisplatin-pemetrexed ± nintedanib
Phase
Phase 3
Sponsor
Boehringer Ingelheim
Registry
Headline result
PFS HR 1.01, negative.
Reported
2019
Enrolled
458
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 6.8 vs 7 months with Nintedanib + chemotherapy compared with Placebo + chemotherapy; about 0.2 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 1 percent higher chance of the event at any given time (hazard ratio 1.01, likely range 0.79 to 1.3).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Epithelioid pleural mesothelioma, first line: cisplatin-pemetrexed ± nintedanib. 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.