LUME-Meso Phase II trial success in patients with unresectable malignant pleural mesothelioma is followed by ongoing LUME-Meso Phase III trial.- Boehringer

Boehringer Ingelheim has announced that the LUME-Meso Phase II trial in patients with unresectable malignant pleural mesothelioma (MPM) met its primary endpoint of progression-free survival (PFS). The data presented at the 17th IASLC World Conference on Lung Cancer in Vienna, showed nintedanib plus pemetrexed/cisplatin demonstrated a meaningful clinical benefit compared to placebo plus pemetrexed/cisplatin, with a significantly improved PFS (9.4 vs 5.7 months, HR = 0.56 and p value =0.0174). Preliminary overall survival (OS) data also favoured nintedanib (18.3 vs 14.5 months, HR = 0.78 and p=0.4132).

Nintedanib (Vargetaf) in combination with docetaxel was approved in the EU in 2014 for use in adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. The most common adverse events (more than grade 3) occurring in nintedanib versus placebo patients were low concentration of neutrophils in the blood (neutropenia), 34% vs 10%; elevated liver enzymes, 14% vs 2% and an increase in gamma glutamyltransferase. 14% vs 0%.

LUME-Meso Phase III [NCT01907100] is a double-blind, randomised, multi-centre Phase II/III confirmatory study of nintedanib in combination with pemetrexed/cisplatin, followed by continuing nintedanib monotherapy (versus placebo in combination with pemetrexed/cisplatin followed by continuing placebo monotherapy), for the treatment of patients with unresectable malignant pleural mesothelioma. This study is currently recruiting participants, and aims to enrol 450 patients across 137 sites in 27 countries.