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Non-metastatic NSCLC and other thoracic malignancies

2278 - Overall survival (OS) and forced vital capacity (FVC) results from the LUME-Meso study of nintedanib (N) + pemetrexed/cisplatin (PEM/CIS) vs placebo (P) + PEM/CIS in chemo-naïve patients (pts) with malignant pleural mesothelioma (MPM)


11 Sep 2017


Non-metastatic NSCLC and other thoracic malignancies


Silvia Novello


Annals of Oncology (2017) 28 (suppl_5): v568-v572. 10.1093/annonc/mdx389


S. Novello1, A.K. Nowak2, F. Grosso3, N. Steele4, S. Popat5, L. Greillier6, T. John7, N.B. Leighl8, M. Reck9, N. Pavlakis10, J.B. Sorensen11, D. Planchard12, G.L. Ceresoli13, B. Hughes14, J. Mazieres15, M.A. Socinski16, U. von Wangenheim17, J. Barrueco18, N. Morsli19, G. Scagliotti20

Author affiliations

  • 1 Department Of Oncology, University of Turin, S. Luigi Hospital, 10124 - Torino/IT
  • 2 School Of Medicine, Faculty Of Medicine And Health Sciences, University of Western Australia, Crawley/AU
  • 3 Department Of Oncology, SS Antonio e Biagio Hospital, Alessandria/IT
  • 4 -, The Beatson West of Scotland Cancer Centre, Glasgow/GB
  • 5 -, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 6 Assistance Publique - Hopitaux De Marseille, Aix Marseille University, 13915 - Marseille/FR
  • 7 Olivia Newton John Cancer Research Institute, Austin Hospital, Heidelberg/AU
  • 8 -, Princess Margaret Cancer Centre, Toronto/CA
  • 9 Department Of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 10 Northern Cancer Institute, St Leonard's, Sydney/AU
  • 11 -, Rigshospitalet, Copenhagen/DK
  • 12 Department Of Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 13 Department Of Oncology, Cliniche Humanitas Gavazzeni, 24125 - Bergamo/IT
  • 14 -, The Prince Charles Hospital, Chermside/AU
  • 15 -, HOP Larrey, Onco, Toulouse/FR
  • 16 -, University of Pittsburgh, Pittsburgh/US
  • 17 -, Boehringer Ingelheim GmbH & Co. KG, Biberach/DE
  • 18 -, Boehringer Ingelheim Pharmaceuticals, Inc., 06877 - Ridgefield/US
  • 19 -, Boehringer Ingelheim France S.A.S., Paris/FR
  • 20 Department Of Oncology, University of Turin, S. Luigi Hospital, Torino/IT


Abstract 2278


N targets MPM by inhibiting VEGFR 1–3, PDGFR α/β, FGFR 1–3, Src and Abl kinases. In a Phase II/III, double-blind, randomised LUME-Meso trial, primary Phase II analysis showed improved progression-free survival (PFS) with N and a trend for prolonged interim OS. FVC, a common pulmonary function test reflecting pt performance and quality-of-life, was also evaluated.


Pts with unresectable MPM (ECOG PS 0–1), stratified by histology, were randomised 1:1 to ≤ 6 cycles PEM (500 mg/m2)/CIS (75 mg/m2, Day 1) + N or P (200 mg bid, Days 2–21), followed by N/P monotherapy until progression/unacceptable toxicity. The primary endpoint was PFS; OS was the secondary endpoint. FVC was a further endpoint, evaluated as percentage change from baseline for cycle (C)1–8 using a mixed-effect model with repeated measures.


87 pts were randomised (N = 44; P = 43). At the primary OS analysis (71% of events), OS benefit favoured N (hazard ratio [HR]=0.77; 95% confidence interval [CI]: 0.46–1.29; p = 0.319) and primary PFS results were confirmed (HR = 0.54; [95% CI]: 0.33–0.87; p = 0.010). Benefit of N was greatest in epithelioid MPM for PFS (HR = 0.49; 95% CI: 0.30–0.82; p = 0.006; median [m] 9.7 vs 5.7 months [mo]) and OS (HR = 0.70; 95% CI: 0.40–1.21; p = 0.197; mOS 20.6 vs 15.2 mo). Adjusted mean (standard error [SE]) FVC change at C8 favoured N over P (all pts: +10.0 [SE: 3.5]% vs + 2.8 [SE: 3.7]%; mean treatment difference [TD]: 7.2 [SE: 4.5]%; pts with epithelioid histology: +14.1 [SE: 2.9]% vs + 4.2 [SE: 3.3]%; mean TD: 9.9 [SE 4.5]%). A trend towards improved FVC with N over P was observed from C2 in all pts and epithelioid histology. Neutropenia was the most frequent Grade ≥3 adverse event (AE; N, 43%; P, 12%); febrile neutropenia rate was low (4.5 vs 0%). AEs leading to discontinuation were lower with N than P (7 vs 17%).


Addition of N to PEM/CIS resulted in a substantial improvement in PFS, a trend for prolonged OS and improvement in the pulmonary function measure FVC. Treatment effect was most pronounced in pts with epithelioid histology; Phase III is recruiting in this population (NCT01907100).

Clinical trial identification


Legal entity responsible for the study

Boehringer Ingelheim Pharma GmbH & Co. KG


Boehringer Ingelheim Pharma GmbH & Co. KG


S. Novello: Honoraria from Roche, Boehringer Ingelheim, Bristol-Meyers Squibb, Eli Lilly, AstraZeneca, Pfizer and Novartis; payment as a consultant from Roche, A.K. Nowak: Payment as consultant from Aduro Biotech, Morphotek, Bayer, AstraZeneca, Sellas Life Sciences, Trizell, Boehringer-Ingelhelm, Epizyme, Roche; travel expenses by Amgen and AstraZeneca; received research funding from Boehringer-Ingelhelm and AstraZeneca. F. Grosso: Travel expenses paid by Boehringer-Ingelhelm and PharmaMar. N. Steele: Honoraria from Pfizer, Novartis; payment as consultant from MSD, Boehringer-Ingelhelm and BMS; travel expenses paid by Pfizer, MSD, Boehringer-Ingelhelm and research funding from Merck Serono, AstraZeneca, Boehringer-Ingelhelm, BMS, Novartis and Roche. S. Popat: Honoraria from Pfizer, Boehringer-Ingelheim (BI), AstraZeneca, Roche, Eli-Lilly, Novartis; payment as consultant from Boehringer-Ingelheim, Roche, Eli-Lilly, Novartis, Pfizer; received funding from BI, Epizyme, BMS, Clovis Oncology, Roche and Eli-Lily. L. Greillier: Honoraria from Roche, Boehringer Ingelheim, BMS, Eli Lilly, AstraZeneca, Pfizer and Novartis; payment as a consultant from Roche, Boehringer Ingelheim and BMS; author’s institution has received research funding from Roche. T. John: Honoraria from Roche, Lilly, BMS, AstraZeneca/MedImmune, Pfizer; payment as consultant from AstraZeneca, AstraZeneca/MedImmune, Pfizer, Roche/Genentech and travel expenses paid by Boehringer-Ingelhelm, Roche and AstraZeneca. N.B. Leighl: Travel expenses paid for by AstraZeneca, MSD, BMS and Pfizer and has received research funding from Novartis. M. Reck: Honoraria, consultation payment and speakers bureau attendance from Boehringer-Ingelhelm, Roche, Eli-Lily, Proacta, AstraZeneca, BMS, MSD, Merck, Novartis, Pfizer and Celgene. N. Pavlakis: Honoraria and payment as consultant from Specialised Therapeutics, Pfizer, Boehringer-Ingelhelm, Merck Serono, Bayer, AstraZeneca, Novartis, Roche, AMtene. Author has also been paid to consult with Sanofi. J.B. Sorensen: Payment as consultant from Roche, Merck, Boehringer-Ingelhelm and Eli-Lilly. D. Planchard: Payment as consultant from Lilly, Boehringer-Ingelhelm, BMS, Pfizer, Clovis Oncology, MSD, Sanofi, AstraZeneca, Novartis and Roche and has received research funding from Novartis. G.L. Ceresoli: Research funding from Bayer. B. Hughes: Payment as consultant from MSD, BMS and Roche and has received travel expenses from MSD. J. Mazieres: Research funding received from BMS and Roche. M.A. Socinski: Honoraria and payment for consultation from Genetech and their institution has received funding from Pfizer. U. von Wangenheim, J. Barrueco, N. Morsli: Employed by Boehringer Ingelhelm. G. Scagliotti: Honoraria from Eli-Lily, AstraZeneca, Roche, Pfizer, MSD; payment as consultant from Eli-Lily; travel expenses by Bayer and has been paid by Eli-Lily and MSD to participate in a Speaker’s Bureau.

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