Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1

• DOI: 10.1016/j.annonc.2023.07.006
• Publication Date: 2023-09-11T08:56:36Z
• Authors: B. Besse; E. Felip; R. Garcia Campelo; M. Cobo; C. Mascaux; A. Madroszyk; F. Cappuzzo; W. Hilgers; G. Romano; F. Denis; S. Viteri; D. Debieuvre; D. Galetta; E. Baldini; M. Razaq; G. Robinet; M. Maio; A. Delmonte; B. Roch; P. Masson; W. Schuette; A. Zer; J. Remon; D. Costantini; B. Vasseur; R. Dziadziuszko; G. Giaccone; M. Zemanová; B. Besse; C. Bonnet; J. Cadranel; C. Chouaid; A. Cortot; D. Debieuvre; B. Delclaux; F. Denis; B. Duchemann; C. El Kouri; F.R. Ferrand; M. Ginoux; W. Hilgers; A. Madroszyk; P. Masson; J. Mazieres; O. Molinier; D. Moro-Sibilot; E. Pichon; C. Mascaux; G. Robinet; B. Roch; G. Zalcman; G. Schmidtke-Schr...; W. Schuette; L. Urban; M. Gottfried; H. Nechushtan; N. Peled; M. Wollner; A. Zer; E. Baldini; L. Bonanno; A. Bonetti; F. Cappuzzo; A. Delmonte; D. Galetta; M. Maio; V. Minotti; A. Rea; G. Romano; D. Tassinari; G. Tonini; R. Dziadziuszko; B. Karaszewska; A. Szczęsna; M. Cobo; J. De Castro; E. Felip; M.R. Garcia Campelo; A. Hernández; T. Moran; M. Provencio; S. Viteri; A. Dasgupta; N. Gabrail; G. Giaccone; A. Harshad; S. Liu; D. Oubre; R. Panikkar; M. Razaq; R. Sanborn
• Keywords: Interim analysis; Clinical endpoint; Pemetrexed

Patients with advanced non-small-cell lung cancer (NSCLC) treated immune checkpoint blockers (ICBs) ultimately progress either rapidly (primary resistance) or after durable benefit (secondary resistance). The vaccine OSE2101 may invigorate antitumor-specific responses ICB failure. objective of ATALANTE-1 was to evaluate its efficacy and safety in these patients. a two-step open-label study the compared standard-of-care (SoC) chemotherapy (CT). human leukocyte antigen (HLA)-A2-positive NSCLC without actionable alterations, failing sequential concurrent CT were randomized (2 : 1) SoC (docetaxel pemetrexed). Primary endpoint overall survival (OS). Interim OS futility analysis planned as per Fleming design. In April 2020 at time interim analysis, decision taken prematurely stop accrual due coronavirus disease 2019 (COVID-19). Final carried out all patients subgroup secondary resistance defined failure monotherapy second line ≥12 weeks. Two hundred nineteen (139 OSE2101, 80 SoC); 118 had ICB. Overall, median non-significantly favored over {hazard ratio (HR) [95% confidence interval (CI)] 0.86 [0.62-1.19], P = 0.36}. subgroup, significantly improved versus [11.1 7.5 months; HR (95% CI) 0.59 (0.38-0.91), 0.017], post-progression (HR 0.46, 0.004), Eastern Cooperative Oncology Group (ECOG) performance status deterioration 0.43, 0.006) Quality Life Questionnaire Core 30 (QLQ-C30) global health (P 0.045). Six-month control rates progression-free similar between groups. Grade ≥3 adverse effects occurred 11.4% 35.1% 0.002). HLA-A2-positive immunotherapy, increased better CT. Further evaluation this population is warranted.