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Mini Oral - NSCLC, metastatic

1260MO - Activity of OSE-2101 in HLA-A2+ non-small cell lung cancer (NSCLC) patients after failure to immune checkpoint inhibitors (ICI): Step 1 results of phase III ATALANTE-1 randomised trial

Date

18 Sep 2020

Session

Mini Oral - NSCLC, metastatic

Presenters

Giuseppe Giaccone

Citation

Annals of Oncology (2020) 31 (suppl_4): S754-S840. 10.1016/annonc/annonc283

Authors

G. Giaccone1, E. Felip2, M. Cobo3, R. Garcia Campelo4, F. DENIS5, E. Quoix6, A. Madroszyk7, D. Debieuvre8, W. Hilgers9, T. Moran10, D. Galetta11, G.D. Romano12, F. Cappuzzo13, G. Robinet14, P. Masson15, S. Viteri16, N. Peled17, D. Costantini18, R. Dziadziuszko19, B. Besse20

Author affiliations

  • 1 Clinical Research, Weill Cornell Medicine, 10065 - New York/US
  • 2 Medical Oncology, Vall d’Hebron University Hospital, 8035 - Barcelona/ES
  • 3 Unidad De Gestión Clínica Intercentros De Oncología Médica, Hospitales Universitarios Regional y Virgen de la Victoria. IBIMA, 29010 - Malaga/ES
  • 4 Medical Oncology, University Hospital A Coruña, 15006 - A Coruña/ES
  • 5 Medical Oncology, Clinique Victor Hugo Le Mans, 72000 - Le Mans/FR
  • 6 Pneumology Department, Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil, 67091 - Strasbourg/FR
  • 7 Medical Oncology, Institut Paoli Calmettes, 13274 - Marseille/FR
  • 8 Pneumology Department, Hopital Emile Muller GHRMSA, 68100 - Mulhouse/FR
  • 9 Medical Oncology, Institut Ste Catherine, 84082 - Avignon/FR
  • 10 Medical Oncology, Hospital Universitari Germans Trias i Pujol, ICO-Badalona, B-ARGO, 08916 - Barcelona/ES
  • 11 Medical Thoracic Oncology Dept., Istituto Tumori Giovanni Paolo II, 70124 - Bari/IT
  • 12 Oncology Department, Ospedale Vito Fazzi, 73100 - Lecce/IT
  • 13 Department Of Oncology And Hematology, AUSL Romagna, 48121 - Ravenna/IT
  • 14 Medical Oncology, C.H.U. Brest - Hôpital Morvan, 29609 - Brest/FR
  • 15 Pneumology Department, Centre Hospitalier de Cholet, 49300 - Cholet/FR
  • 16 Dept. Oncology, Instituto Oncológico Dr. Rosell. Hospital Universitario Dexeus. Grupo QuironSalud, 8028 - Barcelona/ES
  • 17 Cancer Center, Soroka University Medical Center, 84101 - Beer Sheva/IL
  • 18 Development, OSE Immunotherapeutics, 75015 - Paris/FR
  • 19 Oncology And Radiotherapy, Medical University of Gdansk, 80-211 - Gdansk/PL
  • 20 Medical Oncology, Gustave Roussy, 94800 - Villejuif/FR
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Resources

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Abstract 1260MO

Background

Tedopi® is an anticancer vaccine with modified neoepitopes restricted to HLA-A2+ targeting five tumor-associated antigens frequently expressed in lung cancer: CEA, HER2, MAGE2, MAGE3 and P53. ATALANTE-1 was a randomized, open-label, 2-Step phase 3 study comparing the efficacy of Tedopi® with standard treatment (SoC) in HLA-A2+ NSCLC patients in 2nd or 3rd line treatment after progression on ICI.

Methods

HLA-A2+ NSCLC patients, EGFR and ALK negative, having progressed to platinum-based chemotherapy (CT) and anti-PD(L)1, ECOG PS 0-1 were randomized 2:1 to receive Tedopi® subcutaneously Q3W for 6 cycles, followed by maintenance Q8W up to first year, then Q12W, or SoC (docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W). The Step-1 hypotheses were based on the evaluation of 1y-OS rate (Fleming design: H0 futility boundary at 25%; H1 alternative efficacy: 40% of OS rate at 12 months). Step-2 was a superiority study with OS as primary endpoint.

Results

At cutoff of February 2020, 99 patients (Tedopi® n=63; SoC n=36) were randomized and analyzable for Step-1. The 1y-OS was 29/63 (46%) [95%CI 33-59]) in Tedopi® group and 13/36 (36%) [95%CI 21-54] in SoC. The Step-1 endpoint has shown a lower limit of the 95% confidence interval above the futility boundary (25%) with an OS estimate of 10% above the estimate of SoC. Secondary endpoints and subgroup data will be further presented. Grade 3-4 related TEAEs were 11 % in Tedopi® group and 43 % in SoC. There was no related grade 5 TEAE. Related TEAE leading to withdrawal from the study were also less frequent in Tedopi® group (6%) versus SoC (14%). Due to the risk of COVID-19 pandemic on data integrity, following recommendation of the Independent Data Monitoring Committee and Steering Committee, the decision was taken to early terminate the study at Step-1 and definitely stop new accrual while continuing the OS follow-up in all patients.

Conclusions

The Step-1 primary endpoint was positively achieved with a 1y-OS rate of 46% and a good safety profile. Step-1 results shown a favorable benefit/risk of Tedopi® over SoC as 2nd or 3rd line treatment in advanced HLA-A2+ NSCLC patients after failure to ICI.

Clinical trial identification

EudraCT: 2015-003183-36; NCT02654587.

Editorial acknowledgement

Legal entity responsible for the study

OSE Immunotherapeutics.

Funding

OSE Immunotherapeutics.

Disclosure

G. Giaccone: Advisory/Consultancy: CStone; Advisory/Consultancy: Novartis; Advisory/Consultancy: Daiichi; Research grant/Funding (institution): Medimunne; Research grant/Funding (institution): Incyte. E. Felip: Advisory/Consultancy: AbbVie; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Blueprint Medicine; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Elli Lilly; Advisory/Consultancy: Guardant Health; Advisory/Consultancy: Janssen; Advisory/Consultancy: Merck KgaA; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy: Samsung; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Advisory/Consultancy: GSK; Advisory/Consultancy: Bayer; Speaker Bureau/Expert testimony: Medscape; Speaker Bureau/Expert testimony: Prime Oncology; Speaker Bureau/Expert testimony: Touchime ; Research grant/Funding (institution): Fundation Merck Salud; Advisory/Consultancy: Grifols. R. Garcia Campelo: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. F. DENIS: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Shugai; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy: MSD; Advisory/Consultancy, Licensing/Royalties: Sivan. E. Quoix: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony: Shugai; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Takeda; Honoraria (self), interview at ASCO 2019: Medscape. A. Madroszyk: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: MSD. D. Debieuvre: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self): Shugai; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Sandoz; Travel/Accommodation/Expenses: Boehringer Ingelheim. W. Hilgers: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self): MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Advisory/Consultancy, Travel/Accommodation/Expenses: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Roche. T. Moran: Advisory/Consultancy: Roche; Advisory/Consultancy: Boehringer Ingelheim. D. Galetta: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Boehringer Ingelheim; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: BMS; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca. F. Cappuzzo: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD. G. Robinet: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZenaca; Advisory/Consultancy: BMS. S. Viteri: Full/Part-time employment: Pangaea Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Honoraria (self), Travel/Accommodation/Expenses: MSD; Research grant/Funding (institution), Travel/Accommodation/Expenses: Ose Immunotherapeutics; Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck KgaA; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Boston Pharmaceuticals; Research grant/Funding (institution): Exelexis; Research grant/Funding (institution): Novocure; Research grant/Funding (institution): MedImmune. N. Peled: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Foundation Medicine; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Guardian 360; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Genesort; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck KgaA; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): NovellusDx; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Takeda. D. Costantini: Shareholder/Stockholder/Stock options, Licensing/Royalties, Full/Part-time employment, Officer/Board of Directors: OSE Immunotherapeutics. R. Dziadziuszko: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): Foundation Medicine; Honoraria (self), Advisory/Consultancy: Takeda; Advisory/Consultancy: Seattle Genetics. B. Besse: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Beigene; Research grant/Funding (institution): Blueprint Medicine; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Cellgene; Research grant/Funding (institution): Cristal Therapeutics; Research grant/Funding (institution): Daichi-Sankyo; Research grant/Funding (institution): Elli-Lilly; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Inivata; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck KgaA; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Nektar; Research grant/Funding (institution): Onxeo; Research grant/Funding (institution): Ose Immunotherapeutics; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Spectrum Pharmaceuticals; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Tiziana Pharma; Research grant/Funding (institution): Tolero Pharmaceuticals. All other authors have declared no conflicts of interest.

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