2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Poster Session
Time: Sunday June 2, 8:00 AM to 11:00 AM
Location: Hall A
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.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
Poster Board Number:
Poster Session (Board #440b)
J Clin Oncol 37, 2019 (suppl; abstr TPS9121)
Author(s): Enriqueta Felip, Giuseppe Giaccone, Rafal Dziadziuszko, Fabrice Denis, Teresa Moran, Didier Debieuvre, Manuel Cobo, Domenico Galetta, François Roger Vanel, Giampiero Romano, Anne Madroszyk, Christos Chouaid, Francois-Regis Ferrand, Werner Hilgers, Federico Cappuzzo, Philippe Masson, Nir Peled, Berangere Vasseur, Jordi Remon, Benjamin Besse; Vall d´Hebron University Hospital, Barcelona, Spain; Georgetown University, Washington, DC; Medical University of Gdańsk, Department of Oncology and Radiotherapy, Gdańsk, Poland; Institut Inter-Regional de Cancérologie Jean Bernard, Le Mans, France; Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain; Emile Muller Hospital, Mulhouse, France; Hospital Regional Universitario de Malaga, Málaga, Spain; Medical Oncology Department, Clinical Cancer Center Giovanni Paolo II, Bari, Italy; Unité de Cancerologie Thoracique, Nouvel Hopital Civil, Strasbourg, France; Oncologia Medica, Lecce, Italy; Institut Paoli-Calmettes, Marseille, France; Centre Hospitalier Intercommunal (CHI) Creteil, Créteil, France; Hôpital Inter-Armées de Bégin, Saint-Mandé, France; Institut Sainte Catherine, Avignon, France; U.O. Ospedale Santa Maria delle Croc, Ravenna, Italy; Centre Hospitalier De Cholet, Cholet, France; Clalit Health Services, Soroka Medical Center, Beer-Sheeva, Israel; OSE Immunotherapeutics, Paris, France; Centro Integral Oncología Clara Campal Barcelona, HM-Delfos, Barcelona, Spain; Paris-Sud University, Orsay and Gustave Roussy, Villejuif, France
Background: New treatment strategies are needed for advanced NSCLC patients who progress on treatment with immune checkpoint inhibitors (ICI). Tedopi (OSE2101) is a neoepitope vaccine restricted to HLA-A2 positive patients (45%) targeting five tumor-associated antigens frequently expressed in lung cancer cells, ACE, HER2, MAGE2, MAGE3 and P53. Previously, 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 advanced NSCLC patients. ATALANTE-1 (NCT02654587) is a randomized, open-label, phase 3 study comparing the efficacy and safety of TEDOPI with standard of care (SoC) treatment in HLA-A2 positive patients with advanced NSCLC, as second- or third-line therapy. Methods: Patients with advanced NSCLC without EGFR-sensitizing mutations or ALK rearrangements; progressive disease to platinum-based chemotherapy (ChT) with sequential or concurrent ICI; HLA-A2 positivity (blood test); ECOG PS 0-1; with treated and asymptomatic brain metastases,, are randomized 2:1 to receive 5mg Tedopi subcutaneously Q3W for 6 cycles, then Q8W for the reminder of the year and finally Q12W, or SoC treatment with: docetaxel 75 mg/m2 Q3W or pemetrexed 500 mg/m2 Q3W (in non-squamous and pemetrexed-naïve patients). Treatment continues until progression, intolerable toxicity or consent withdrawal, in both arms. Patients are stratified by histology, best response to first line, and line rank of ICI. Tumor assessment is performed every 6 weeks (RECIST 1.1). Primary endpoint is OS. Secondary end points are PFS, ORR, DCR, and 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 (1year OS rate) is planned in the first 84 patients treated with Tedopi. Last trial review by the DMC in June 18 suggested that the trial continues as planned. Translational research will be performed evaluating pharmacodynamic markers of efficacy such as immunogenicity response against Tedopi vaccine neoantigens, as well as parameters in liquid and tissue biopsies. End January 19, 87 patients (51 Tedopi, 36 Soc) have been enrolled. Clinical trial information: NCT02654587