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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5209 - Maintenance treatment with the TLR9 agonist lefitolimod in extensive-stage small-cell lung cancer (ES-SCLC): Final results from the randomized phase 2 IMPULSE study

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Cytotoxic Therapy

Tumour Site

Presenters

Michael Thomas

Citation

Annals of Oncology (2018) 29 (suppl_8): viii596-viii602. 10.1093/annonc/mdy298

Authors

M. Thomas1, S. Ponce Aix2, A. Navarro Mendivil3, J. Riera Knorrenschild4, M. Schmidt5, E. Wiegert6, K. Kapp7, C. Mauri8, M. Domine Gomez9, J. Kollmeier10, P. Sadjadian11, K. Fröhling12, R.M. Huber13, M. Wolf14

Author affiliations

  • 1 Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital; Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), 69126 - Heidelberg/DE
  • 2 Medical Oncology, University Hospital 12 De Octubre, 28041 - Madrid/ES
  • 3 Vall D' Hebron Institute Of Research (vhir), Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 4 Klinik Für Hämatologie, Onkologie Und Immunologie, Uniklinikum Giessen und Marburg, 35043 - Marburg/DE
  • 5 Early & Translational R&d, Mologen AG, 14195 - Berlin/DE
  • 6 Clinical Development, Mologen AG, 14195 - Berlin/DE
  • 7 Translational R&d, Mologen AG, 14195 - Berlin/DE
  • 8 Divison Of Medicine, University College London, WC1E 6JF - London/GB
  • 9 Medical Oncology Department, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 10 Lungenklinik Heckeshorn, HELIOS Klinikum Emil von Behring GmbH, Berlin/DE
  • 11 Klinik Für Hämatologie, Onkologie Und Palliativmedizin, Johannes Weseling Klinikum, 32429 - Minden/DE
  • 12 Klinik Für Innere Medizin/pneumologie, Kath. Klinikum Koblenz-Montabaur, Koblenz/DE
  • 13 Thoracic Oncology Centre Munich, LMU Klinikum der Universität München, 80336 - Munich/DE
  • 14 Medizinische Klinik Iv, Klinik Kassel, 34125 - Kassel/DE

Resources

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Abstract 5209

Background

The immune surveillance reactivator lefitolimod (MGN1703), a DNA-based TLR9 agonist, is currently in a comprehensive clinical development program including a phase 3 trial in mCRC. The phase 2 IMPULSE study was designed to evaluate efficacy and safety of lefitolimod in ES-SCLC, an indication with high unmet medical need and stagnant treatment improvement in the last decades.

Methods

IMPULSE is a randomized, international, multicenter, open-label trial to assess the effect of lefitolimod on overall survival (OS) in ES-SCLC. 103 patients with objective tumor response following 4 cycles of platinum-based first-line induction therapy were randomized 3:2 to receive either lefitolimod maintenance therapy or local standard of care until progression or unacceptable toxicity.

Results

From 103 patients, 62 were randomized to lefitolimod, 41 to the control arm. Patient demographics and response patterns to first-line therapy were balanced. Lefitolimod exhibited a favorable safety profile in this vulnerable population and pharmacodynamic assessment confirmed the mode-of-action showing clear activation of monocytes and production of interferon-gamma-induced protein 10. While in the ITT population no relevant effect of lefitolimod on OS could be observed, two pre-defined patient subgroups indicated promising results, favoring lefitolimod with respect to OS: Patients with a low frequency of activated CD86+ B cells (HR 0.53, 95%CI 0.26-1.08; n = 38 of 88 analyzed) and patients with reported chronic obstructive pulmonary disease (COPD) (HR 0.48, 95%CI 0.20-1.17, n = 25 of 103). Notably, a post-hoc analysis revealed that a strong lefitolimod-induced immune activation translated into an OS benefit when analysed after 4 weeks of treatment. Two patients from the lefitolimod arm exhibited long-term disease control.

Conclusions

The IMPULSE study showed (1) the expected pharmacodynamic response, (2) positive efficacy signals in two pre-defined subgroups regarding OS and (3) a favorable safety profile. This data provides significant guidance for defining patient populations most likely to benefit from lefitolimod treatment.

Clinical trial identification

NCT02200081.

Legal entity responsible for the study

Mologen AG.

Funding

Mologen AG.

Editorial Acknowledgement

Disclosure

M. Schmidt, K. Kapp, E. Wiegert, C. Mauri: Employee: Mologen AG. All other authors have declared no conflicts of interest.

Resources from the same session

5671 - The landscape of NTRK fusions in Chinese solid tumor patients

Presenter: Qi Ling

Session: Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Resources:

Abstract

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