Nintedanib (BIBF 1120) in Mesothelioma

Summary

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

Timeline

Start

2013-09-19

Primary completion

2018-03-16

Completion

2018-08-31

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (other test); Placebo vs Nintedanib; p = 0.0174; Hazard Ratio (HR) 0.555 (95% CI 0.340 to 0.907); Proportional hazards mode reads as mixed primary results NCT01907100 ↗

registry analysis (other test); Placebo vs Nintedanib; p = 0.5430; Hazard Ratio (HR) 1.01 (95% CI 0.79 to 1.30); Proportional hazards model; note: one-sided p-value reads as mixed primary results NCT01907100 ↗

paper The primary progression-free survival endpoint of the phase 3 part of LUME-Meso was not met and phase 2 findings were not confirmed. reads as mixed primary results PMID 31103412 ↗

release “the LUME-Meso Phase II trial in patients with unresectable malignant pleural mesothelioma (MPM) met its primary endpoint of progression-free survival (PFS).” reads as met primary endpoint prnewswire.com ↗

Publications

• Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nintedanib	Small molecule	200 mg	—
Comparator	Cisplatin	Other / unclassified	75 mg/m2	—
Background	Pemetrexed	Small molecule	500 mg/m2	—

Indications