OnCo
trialsTrialNegative

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
NCT01907100
Headline result
PFS HR 1.01, negative.
Reported
2019
Enrolled
458

Outcomes

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In plain words
What these results mean for people, not percentages
458 people took part
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.

458 participants enrolled.

Progression-free survivalprimary
HR 1.01 (0.79–1.3)
Nintedanib + chemotherapy
6.8 mo
Placebo + chemotherapy
7 mo
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survivalprimaryNintedanib + chemotherapy2296.8 months1.01 (0.79–1.3)—link
Placebo + chemotherapy2297 months

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Mesothelioma

drugs

2
NegativeSmall-molecule kinase inhibitor (VEGFR/FGFR/PDGFR)
Nintedanib · Ofev (fibrosis); Vargatef (NSCLC, EU)
ApprovedCytotoxic (antifolate)
Pemetrexed · Alimta (and generics)