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Poster session 18

1914P - Nintedanib(N) as switch maintenance treatment in malignant pleural mesothelioma (MPM) (NEMO): A double-blind randomized phase II trial (EORTC-08112-LCG)

Date

14 Sep 2024

Session

Poster session 18

Topics

Cancer Research

Tumour Site

Mesothelioma

Presenters

Omar Abdel-Rahman

Citation

Annals of Oncology (2024) 35 (suppl_2): S1115-S1121. 10.1016/annonc/annonc1613

Authors

O.M. Abdel-Rahman1, P. Taylor2, J. Raskin3, C. Dazzi4, V. Surmont5, R. Young6, A.C. Toffart7, P. Jankowska8, S.I. Marreaud9, L. Boone9, S. Popat10

Author affiliations

  • 1 Oncology, Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 2 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 3 Thoracic Oncology, UZA - University Hospital Antwerp, 2650 - Edegem/BE
  • 4 Medical Oncology, Ospedale Santa Maria delle Croci, 48121 - Ravenna/IT
  • 5 Respiratory Medicine/thoracic Oncology, UZ Gent - Universitair Ziekenhuis Gent, 9000 - Gent/BE
  • 6 Medical Oncology, Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust, S10 2SJ - Sheffield/GB
  • 7 Pulmonology Unit, CHU Grenoble-Alpes - Le site nord à La Tronche - Hopital Michallon, 38700 - La Tronche/FR
  • 8 Oncology, Musgrove Park Hospital - Taunton and Somerset NHS Foundation Trust, TA1 5DA - Taunton/GB
  • 9 Medical Department, EORTC AISBL/IVZW - European Organisation for Research and Treatment of Cancer, 1200 - Brussels/BE
  • 10 Department Of Medicine, The Royal Marsden Hospital - NHS Foundation Trust, SW3 6JJ - London/GB

Resources

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Abstract 1914P

Background

VEGF and FGFR play major roles in MPM tumorigenesis. Bevacizumab(bev)-platinum-pemetrexed (PP) with bev maintenance improved progression-free (PFS) and overall survival (OS) in the MAPS trial. N is an angiokinase inhibitor with antifibrotic properties targeting VEGF1-3, PDGFRA/B, FGFR1-3, SRC, ABL. VEGF inhibitors previously showed encouraging activity and N’s role as switch maintenance remained unknown. During enrolment, the LUME-Meso phase III trial reported no OS improvement for N-PP and N maintenance in epithelioid MPM and cediranib-PP demonstrated no significant PFS benefit (SWOG S0905).

Methods

We enrolled treatment naïve unresectable MPM (all histology), adequate organ function, no unstable co-morbidities, no N contraindication, performance status 0-2 and no progression after 4-6 cycles PP. Patients(pts) were randomized to N 200mg BID or placebo, continued until loss of clinical benefit, toxicity, or death. Primary endpoint was PFS, secondary endpoints were OS, time to treatment failure (TTF), overall response rate (ORR) and safety. 114 pts were planned for recruitment to target PFS HR=0.62.

Results

The study closed due to poor accrual with 37 pts randomized. We present final analyses. Demographics/efficacy shown (Table). Grade≥3 adverse events (AEs) were observed in 27.8%(N) vs 10.5%(placebo), no deaths from toxicity. Commonest AEs were typical for N. Table: 1914P

N, n=18 Placebo, n=19 HR (95% CI)
Median follow up (mo) 48.7 42.4
M:F (n) 12:6 15:4
Epithelioid (%) 78 79
Median treatment duration (weeks) 11.8 24.3
PFS (mo) 3.4 4.6 2.25 (1.07-4.73)
OS (mo) 13.1 38.9 2.38 (1.05-5.43)
TTF (mo) 2.0 4.6 2.55 (1.22-5.32)
Further anticancer treatment (%) 72 79
Further immunotherapy (%) 46 87
.

Conclusions

Despite closing early, whilst imbalanced by subsequent immunotherapy use, NEMO suggests a detrimental effect of maintenance N compared with placebo (Sponsor, EORTC; Funding, Boehringer Ingelheim/EORTC; NCT02863055).

Clinical trial identification

EORTC-08112-LCG; NCT02863055.

Editorial acknowledgement

Legal entity responsible for the study

EORTC.

Funding

Boehringer Ingelheim.

Disclosure

S. Popat: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Novartis, Amgen, Janssen, Daiichi Sankyo, AstraZeneca, Bayer, BMS, Blueprint, Merck Serono, Guardant Health, Takeda, Lilly, Roche, Turning Point Therapeutics, GSK, MSD, Pfizer, Sanofi, EQRx, AnHeart, Arcus Biosciences, Ellipses, Gilead, IO Biotech, Mirati; Financial Interests, Personal, Invited Speaker: Medscape, VJ Oncology, Novocure, PharmaMar; Financial Interests, Institutional, Other, Sub-investigator: Amgen; Financial Interests, Institutional, Coordinating PI: Ariad, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Takeda, Turning Point Therapeutics, Roche, Janssen, BMS, Lilly; Financial Interests, Institutional, Local PI: AstraZeneca, Roche, GSK, Trizel; Financial Interests, Institutional, Other, Sub-Investigator: MSD, Blueprint; Financial Interests, Institutional, Research Grant: Guardant Health; Non-Financial Interests, Leadership Role, Chair of Steering Committee, Unpaid: British Thoracic Oncology Group; Non-Financial Interests, Officer, Thoracic Faculty, Unpaid: European Society of Medical Oncology; Non-Financial Interests, Leadership Role, Foundation Council Member, Unpaid: European Thoracic Oncology Platform; Non-Financial Interests, Advisory Role, Mesothelioma Committee, Unpaid: International Association for the Study of Lung Cancer; Non-Financial Interests, Member of Board of Directors, Unpaid: Mesothelioma Applied Research Foundation; Non-Financial Interests, Advisory Role, Honorary Clinical Advisor, Unpaid: ALK Positive UK; Non-Financial Interests, Advisory Role, Research Advisory Group Member, Unpaid: Ruth Strauss Foundation; Non-Financial Interests, Advisory Role, Scientific Advisory Board Member, Unpaid: Lung Cancer Europe. All other authors have declared no conflicts of interest.

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