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Poster Display session 1

2352 - ATALANTE-1 randomized phase 3 trial, OSE-2101 versus standard treatment as second or third line in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients


28 Sep 2019


Poster Display session 1


Tumour Site

Non-Small Cell Lung Cancer


Enriqueta Felip


Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260


E. Felip1, B. Besse2, R. Dziadziuszko3, M. Cobo Dols4, F. Denis5, M. García-Campelo6, D. Debieuvre7, A. Catino8, M.T. Moran Bueno9, A. Madroszyk Flandin10, P. Masson11, C. Chouaid12, P. Lianes13, F. Cappuzzo14, A. Delmonte15, G. Robinet16, G. Romano17, V. Gabarre18, J. Remon Masip19, G. Giaccone20

Author affiliations

  • 1 Medical Oncology Service (lung Cancer Unit)  , Vall d'Hebron University Hospital, 08035 - Barcelona/ES
  • 2 Dept Of Cancer Medicine, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 3 Department Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
  • 4 Medical Oncology Department, 1 Hospital Regional Universitario de Málaga, 29009 - Málaga/ES
  • 5 Dept. Oncology, Clinique Victor Hugo, 7200 - Le Mans/FR
  • 6 Medical Oncology Department, Complejo Hospitalario Universitario A Coruna (CHUAC), 15006 - La Coruña/ES
  • 7 Pneumologie, Hopital Emile Muller, 68100 - Mulhouse/FR
  • 8 Dept. Oncology, Istituto Tumori Giovanni Paolo II, 70124 - Bari/IT
  • 9 Medical Oncology Department, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, 08916 - Badalona/ES
  • 10 Dept. Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 11 Oncology, CH Cholet, 49 - Cholet/FR
  • 12 Pneumologie, CH Intercommunal de Créteil, 94010 - Créteil/FR
  • 13 Medical Oncology Department, Hospital de Mataro - Consorcio Sanitario del Maresme, 8304 - Mataro/ES
  • 14 Oncology And Hematology, Ospedale Santa Maria delle Croci, 48121 - Ravenna/IT
  • 15 Medical Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 16 Pneumologie, C.H.U. Brest - Hôpital Morvan, 29609 - Brest/FR
  • 17 Dept. Oncology, Ospedale Vito Fazzi, 73100 - Lecce/IT
  • 18 Paris, OSE Immunotherapeutics, 75014 - Paris/FR
  • 19 Dept. Oncology, CIOCC- Centro Integral Oncológico Clara Campal, 08023 - Barcelona/ES
  • 20 Oncology, Lombardi Cancer Center Georgetown University, 20007 - Washington DC/US


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Abstract 2352


Moving immune checkpoint inhibitors (ICI) in first-line setting in advanced NSCLC, new treatment strategies are needed for patients who progress on treatment with ICI. Tedopi® (OSE-2101) is a neoepitope vaccine restricted to HLA-A2 positive patients (∼45% of NSCLC) targeting five tumor-associated antigens expressed in lung cancer cells: ACE, HER2, MAGE2, MAGE3 and P53. In a phase II trial (Barve et al. JCO 2008), Tedopi® showed a median overall survival (OS) of 17.3 months with a manageable safety profile in pre-treated advanced NSCLC patients. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase III study comparing the efficacy of Tedopi® with standard treatment (SoC) in HLA-A2 positive patients with advanced NSCLC after progression on ICI.

Trial design

Patients with advanced NSCLC (EGFR and ALK negative), progressive disease to platinum-based chemotherapy with sequential or concurrent ICI, HLA-A2 positivity (blood test), ECOG PS 0-1, treated and asymptomatic brain metastases allowed, are randomized 2:1 to receive 1 ml Tedopi® subcutaneously Q3W for 6 cycles, then Q8W for the remainder of the year and finally Q12W, or SoC treatment (docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W). In both arms, treatment continues until progression, intolerable toxicity or consent withdrawal. Stratification criteria are histology, best response to first-line, line rank of ICI. Tumor assessment is performed every 6 weeks (RECIST 1.1). Primary endpoint is OS; Secondary endpoints are: Progression Free Survival, Objective Response Rate , Disease Control Rate , Duration of response, Quality of Life and safety. This is a superiority study with a hazard ratio of 0.7, two-sided alpha 5% and power 80%, after 278 events are observed. An independent analysis (1y-OS rate) is planned in the first 84 patients treated with Tedopi®. Last study review by the Data Monitoring Committee in June 18 suggested that the study continues as planned. Translational research will evaluate pharmacodynamic markers of efficacy baseline and after treatment initiation in this population of NSCLC patients who progressed after ICI treatment.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

OSE Immunotherapeutics, Paris, France.


OSE Immunotherapeutics, Paris, France.


V. Gabarre: Full / Part-time employment, employee: OSE immunotheapeuticds. J. Remon Masip: Travel / Accommodation / Expenses: OSE immunotheapeuticds. All other authors have declared no conflicts of interest.

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