Abstract 2352
Background
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
NCT02654587.
Editorial acknowledgement
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.
Resources from the same session
2728 - MicroRNA expression and DNA methylation profiles do not distinguish between primary and recurrent well-differentiated liposarcoma
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
3197 - Genomic Alterations, Tumor Mutation Burden and Prognosis of Chinese Cardiac Sarcoma Patients
Presenter: Na Zhu
Session: Poster Display session 1
Resources:
Abstract
4214 - Evaluation of a peptide-conjugated alkylator melflufen in osteosarcoma preclinical models
Presenter: Konstantin Byrgazov
Session: Poster Display session 1
Resources:
Abstract
2654 - Expression analysis of NHEJ and HR genes in Ewing sarcomas: indications of DSB repair dysfunction
Presenter: Anastasios Kyriazoglou
Session: Poster Display session 1
Resources:
Abstract
4383 - Epidemiology of Synovial Sarcoma in EU28 countries
Presenter: Nedra Joseph
Session: Poster Display session 1
Resources:
Abstract
1937 - Resection Of High-Grade Large Soft Tissue Sarcoma With Adequate Wide Margin Can Lead To Good Local Control Without Adjuvant Radiotherapy
Presenter: Toshiyuki Kunisada
Session: Poster Display session 1
Resources:
Abstract
3757 - Influence of eribulin on proliferation, migration and invasion properties of leiomyosarcoma cell line models
Presenter: Marta Mendiola
Session: Poster Display session 1
Resources:
Abstract
1040 - EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
1048 - A Phase 2 biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, a disease with a high unmet need
Presenter: Kan Yonemori
Session: Poster Display session 1
Resources:
Abstract
1511 - A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010)
Presenter: Herbert Loong
Session: Poster Display session 1
Resources:
Abstract