LUME-Meso randomised 458 patients with epithelioid pleural mesothelioma to first-line cisplatin and pemetrexed with nintedanib or placebo. The phase 2 progression signal for the multi-kinase inhibitor vanished in phase 3, with no delay in progression and no gain in life, a lesson in the unreliability of small phase 2 signals in this disease.
LUME-Meso, trial NCT01907100 sponsored by Boehringer Ingelheim and reported in 2019, found that the phase 2 progression signal for the multi-kinase inhibitor nintedanib vanished in phase 3. It randomised 458 patients with epithelioid pleural mesothelioma to nintedanib or placebo with first-line cisplatin and pemetrexed and found no difference in progression-free survival and no survival benefit. OnCo links it to mesothelioma, nintedanib and pemetrexed. The record treats it as a lesson in the unreliability of small randomised phase 2 progression signals in mesothelioma, and why such signals so often fail to replicate in this disease is the open question.
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.
Shares Nintedanib, Boehringer Ingelheim, Anti-angiogenic therapy, Small-molecule kinase inhibitors.
Shares Mesothelioma, Pemetrexed, Anti-angiogenic therapy.
Shares Boehringer Ingelheim, Pemetrexed, Small-molecule kinase inhibitors.
Shares Boehringer Ingelheim, Pemetrexed, Small-molecule kinase inhibitors.
Shares Boehringer Ingelheim, Small-molecule kinase inhibitors.
Shares Mesothelioma, Pemetrexed.
Shares Mesothelioma, Pemetrexed.
Shares Pemetrexed, Anti-angiogenic therapy, Small-molecule kinase inhibitors.