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
2935 - Correlation of progression free survival-2 and overall survival in solid tumors
Presenter: Paul Mainwaring
Session: Poster Display session 1
Resources:
Abstract
2273 - High performance of serial tumor biopsies in first in human (FIH) phase I trials.
Presenter: Jun Sato
Session: Poster Display session 1
Resources:
Abstract
5933 - Response rates and lesion-level progression patterns of solid tumor patients in an academic phase 1 program: implications for tumor heterogeneity
Presenter: Christopher Chen
Session: Poster Display session 1
Resources:
Abstract
3569 - Clinical Benefit and Response Rate in Early Phase Clinical Trials: First Report from a Single-Institution Study
Presenter: Antonio Marra
Session: Poster Display session 1
Resources:
Abstract
4139 - Patient (pt) selection for immunotherapeutic early-phase clinical trials (ieCTs): a single Phase I Unit experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract
4451 - Improving patient selection for immuno-oncology phase 1 trials: an external validation of five prognostic scores at Claudius Regaud Institute of Toulouse, Oncopôle (IUCT-O).
Presenter: Ghassan Al Darazi
Session: Poster Display session 1
Resources:
Abstract
1696 - Demonstrating the Changing Trends in Phase 1 Clinical Trials
Presenter: Christina Guo
Session: Poster Display session 1
Resources:
Abstract
3202 - Participation of Women in phase 1 oncology clinical trials
Presenter: Laura Vidal
Session: Poster Display session 1
Resources:
Abstract
4518 - Predictors for early trial discontinuation of patients with cancer participating in phase I clinical trials
Presenter: Joeri Douma
Session: Poster Display session 1
Resources:
Abstract
4368 - Safety of Tumor Treating Fields delivery to the torso: Meta analysis from TTFields clinical trials
Presenter: Federica Grosso
Session: Poster Display session 1
Resources:
Abstract