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ATALANTE-1 randomized phase III trial, OSE-2101 versus standard treatment as second or third-line in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients
abstracts
Annals of Oncology
ATALANTE-1 randomized phase III trial, OSE-2101 versus standard treatment as second or third-line in HLA-A2 positive advanced nonsmall cell lung cancer (NSCLC) patients
E. Felip1, B. Besse2, R. Dziadziuszko3, M. Cobo Dols4, F. Denis5, M-R. Garcıa-Campelo6, D. Debieuvre7, A. Catino8, M.T. Moran Bueno9, A-C. Madroszyk Flandin10, P. Masson11, C. Chouaid12, P. Lianes13, F. Cappuzzo14, A. Delmonte15, G. Robinet16, G. Romano17, V. Gabarre18, J. Remon Masip19, G. Giaccone20 1 Medical Oncology Service (Lung Cancer Unit), Vall d’Hebron University Hospital, Barcelona, Spain, 2Department of Cancer Medicine, Gustave Roussy - Cancer Campus, Villejuif, France, 3Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, 4Medical Oncology Department, 1 Hospital Regional Universitario de M alaga, M alaga, Spain, 5Department of Oncology, Clinique Victor Hugo, Le Mans, France, 6Medical Oncology Department, Complejo Hospitalario Universitario A Coruna (CHUAC), La Coru~ na, Spain, 7Pneumologie, Hopital Emile Muller, Mulhouse, France, 8Dept. Oncology, Istituto Tumori Giovanni Paolo II, Bari, Italy, 9 Department of Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain, 10Department of Oncology, Institute Paoli Calmettes, Marseille, France, 11Oncology, CH Cholet, Cholet, France, 12Pneumologie, CH Intercommunal de Cre´teil, Cre´teil, France, 13Medical Oncology Department, Hospital de Mataro - Consorcio Sanitario del Maresme, Mataro, Barcelona, Spain, 14Oncology and Hematology, Ospedale Santa Maria delle Croci, Ravenna, Italy, 15Medical Oncology, Istituto Tumori della Romagna I.R.S.T., Meldola, Italy, 16Pneumologie, C.H.U. Brest - Hoˆpital Morvan, Brest, France, 17Dept. Oncology, Ospedale Vito Fazzi, Lecce, Italy, 18Paris, OSE Immunotherapeutics, Paris, France, 19 Department of Oncology, CIOCC- Centro Integral Oncol ogico Clara Campal, Barcelona, Spain, 20Oncology, Lombardi Cancer Center Georgetown University, Washington, DC, USA Background: Moving immune checkpoint inhibitors (ICI) in first-line setting in advanced NSCLC, new treatment strategies are needed for patients who progress on R (OSE-2101) is a neoepitope vaccine restricted to HLA-A2 treatment with ICI. TedopiV 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 R showed a median overall survival (OS) of 17.3 months with a al. JCO 2008), TedopiV manageable safety profile in pre-treated advanced NSCLC patients. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase III study comparing the efficacy of R with standard treatment (SoC) in HLA-A2 positive patients with advanced TedopiV 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 R subcutaneously Q3W for 6 cycles, allowed, are randomized 2:1 to receive 1 ml TedopiV 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 R . Last study analysis (1y-OS rate) is planned in the first 84 patients treated with TedopiV 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: NCT02654587. Legal entity responsible for the study: OSE Immunotherapeutics, Paris, France. Funding: OSE Immunotherapeutics, Paris, France. Disclosure: 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.
v658 | NSCLC, Metastatic
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz260.114/5576350 by guest on 26 October 2019
1592TiP
Annals of Oncology
ATALANTE-1 randomized phase III trial, OSE-2101 versus standard treatment as second or third-line in HLA-A2 positive advanced nonsmall cell lung cancer (NSCLC) patients
E. Felip1, B. Besse2, R. Dziadziuszko3, M. Cobo Dols4, F. Denis5, M-R. Garcıa-Campelo6, D. Debieuvre7, A. Catino8, M.T. Moran Bueno9, A-C. Madroszyk Flandin10, P. Masson11, C. Chouaid12, P. Lianes13, F. Cappuzzo14, A. Delmonte15, G. Robinet16, G. Romano17, V. Gabarre18, J. Remon Masip19, G. Giaccone20 1 Medical Oncology Service (Lung Cancer Unit), Vall d’Hebron University Hospital, Barcelona, Spain, 2Department of Cancer Medicine, Gustave Roussy - Cancer Campus, Villejuif, France, 3Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland, 4Medical Oncology Department, 1 Hospital Regional Universitario de M alaga, M alaga, Spain, 5Department of Oncology, Clinique Victor Hugo, Le Mans, France, 6Medical Oncology Department, Complejo Hospitalario Universitario A Coruna (CHUAC), La Coru~ na, Spain, 7Pneumologie, Hopital Emile Muller, Mulhouse, France, 8Dept. Oncology, Istituto Tumori Giovanni Paolo II, Bari, Italy, 9 Department of Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain, 10Department of Oncology, Institute Paoli Calmettes, Marseille, France, 11Oncology, CH Cholet, Cholet, France, 12Pneumologie, CH Intercommunal de Cre´teil, Cre´teil, France, 13Medical Oncology Department, Hospital de Mataro - Consorcio Sanitario del Maresme, Mataro, Barcelona, Spain, 14Oncology and Hematology, Ospedale Santa Maria delle Croci, Ravenna, Italy, 15Medical Oncology, Istituto Tumori della Romagna I.R.S.T., Meldola, Italy, 16Pneumologie, C.H.U. Brest - Hoˆpital Morvan, Brest, France, 17Dept. Oncology, Ospedale Vito Fazzi, Lecce, Italy, 18Paris, OSE Immunotherapeutics, Paris, France, 19 Department of Oncology, CIOCC- Centro Integral Oncol ogico Clara Campal, Barcelona, Spain, 20Oncology, Lombardi Cancer Center Georgetown University, Washington, DC, USA Background: Moving immune checkpoint inhibitors (ICI) in first-line setting in advanced NSCLC, new treatment strategies are needed for patients who progress on R (OSE-2101) is a neoepitope vaccine restricted to HLA-A2 treatment with ICI. TedopiV 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 R showed a median overall survival (OS) of 17.3 months with a al. JCO 2008), TedopiV manageable safety profile in pre-treated advanced NSCLC patients. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase III study comparing the efficacy of R with standard treatment (SoC) in HLA-A2 positive patients with advanced TedopiV 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 R subcutaneously Q3W for 6 cycles, allowed, are randomized 2:1 to receive 1 ml TedopiV 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 R . Last study analysis (1y-OS rate) is planned in the first 84 patients treated with TedopiV 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: NCT02654587. Legal entity responsible for the study: OSE Immunotherapeutics, Paris, France. Funding: OSE Immunotherapeutics, Paris, France. Disclosure: 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.
v658 | NSCLC, Metastatic
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz260.114/5576350 by guest on 26 October 2019
1592TiP