Meeting
2017 ASCO Annual Meeting
Mature overall survival (OS) 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).
Authors
Anna K. Nowak
School of Medicine, Faculty of Medicine and Health Sciences, University of Western Australia, Crawley, Australia
Anna K. Nowak , Federica Grosso , Nicola Steele , Silvia Novello , Sanjay Popat , Laurent Greillier , Tom John , Natasha B. Leighl , Martin Reck , Nick Pavlakis , Jens Benn Soerensen , David Planchard , Giovanni Luca Ceresoli , Brett Gordon Maxwell Hughes , Julien Mazieres , Mark A. Socinski , Derek Velema , Ute von Wangenheim , Nassim Morsli , Giorgio V. Scagliotti
Organizations
School of Medicine, Faculty of Medicine and Health Sciences, University of Western Australia, Crawley, Australia, Oncology, SS Antonio e Biagio General Hospital, Alessandria, Italy, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, University of Turin, Department of Oncology, Torino, Italy, Royal Marsden Hospital, London, United Kingdom, Assistance Publique - Hopitaux De Marseille, Marseille, France, Olivia Newton-John Cancer Research Institute, Heidelberg, Australia, Princess Margaret Cancer Centre, Toronto, ON, Canada, Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany, Northern Cancer Institute, University of Sydney, Sydney, Australia, Rigshospitalet Blegdamsvej 9, Copenhagen, Denmark, Gustave Roussy, Department of Medical Oncology, Villejuif, France, Cliniche Humanitas Gavazzeni, Department of Oncology, Bergamo, Italy, The Prince Charles Hospital, Brisbane, Australia, HOP Larrey, Onco, Chemin de Pouvourville, Toulouse, France, University of Pittsburgh Centre Avenue, Pittsburgh, PA, Boehringer Ingelheim Canada Ltd./Ltée, Burlington, ON, Canada, Boehringer Ingelheim Pharma GmbH and Co. KG, Biberach, Germany, Boehringer Ingelheim France, S.A.S., Paris, France, University of Turin, Department of Oncology, S. Luigi Hospital, Torino, Italy
Research Funding
Pharmaceutical/Biotech Company
Background: LUME-Meso is a Phase (Ph) II/III, double-blind, randomized study. N targets MPM by inhibiting VEGFR 1–3, PDGFR α/β, FGFR 1–3, Src and Abl kinases. Primary analysis of the Ph II data demonstrated improved progression-free survival (PFS; hazard ratio [HR]=0.56; 95% confidence interval [CI] 0.34–0.91; p=0.017). Mature Ph 2 OS and updated PFS results are reported here. Methods: Pts with unresectable MPM (ECOG PS 0–1) were stratified by histology (epithelioid/biphasic) and randomized 1:1 to receive ≤6 cycles PEM (500 mg/m2)/CIS (75 mg/m2) Day 1 + N or P (200 mg bid, Days 2–21), followed by N or P monotherapy until progression or toxicity. The primary endpoint was PFS. The primary OS analysis and updated PFS analysis were performed as predefined. Results: 87 pts were randomly assigned (N=44, P=43). OS benefit favored N over P treatment (HR=0.77; 95% CI 0.46–1.29; p=0.319; 62 [71%] OS events) and was greatest in epithelioid pts (HR=0.70; 95% CI 0.40–1.21; p=0.197) with a median (m) OS gain of 5.4 months (mOS [95% CI]: 20.6 [16.2–28.8] N vs 15.2 [12.2–23.6] P). Updated PFS results (HR=0.54; 95% CI 0.33–0.87; p=0.010) also showed greatest benefit for epithelioid pts (HR=0.49; 95% CI 0.30–0.82; p=0.006) with a mPFS gain of 4.0 months (mPFS [95% CI]: 9.7 [7.2–12.4] N vs 5.7 [5.5–7.0] P). Improved forced vital capacity, objective response rates and duration of response were also observed with N treatment. Drug-related adverse events (AEs) in N- vs P-treated pts were 97.7% vs 97.6%. Grade ≥3 AEs of note included neutropenia (27.3% vs 4.9%), ALT (11.4% vs 0) and GGT (6.8% vs 0) elevations, and diarrhea (6.8% vs 0). AEs led to trial discontinuation in only 3 (6.8%) N vs 7 (17.1%) P pts. Conclusions: Mature Ph II OS data show that adding N to standard 1st-line treatment gives a strong signal towards improved OS. Updated PFS confirmed the primary analysis; AEs were manageable. The greatest clinical benefit was observed in pts with epithelioid histology. Median survival of 20.6 months in epithelioid pts treated with N is unprecedented in advanced MPM trials. Ph III is actively recruiting in this pt population. Clinical trial information: NCT01907100
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Abstract Details
Session Type
Oral Abstract Session
Session Title
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Track
Lung Cancer
Sub Track
Mesothelioma
Clinical Trial Registration Number
NCT01907100
Citation
J Clin Oncol 35, 2017 (suppl; abstr 8506)
DOI
10.1200/JCO.2017.35.15_suppl.8506
Abstract #
8506
Abstract Disclosures
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