PIONeeR Project to Reveal Phase Ib/IIa Study Findings at ESMO 2024

The Presidential Symposium titled "Eyes to the future" at the ESMO Congress 2024 will highlight the first-ever presentation of the clinical trial data from the PIONeeR Project (Precision Immuno-Oncology for advanced Non-Small Cell Lung Cancer Patients with PD-(L)1 ICI Resistance). PIONeeR is an international hospital-university research initiative focusing on overcoming resistance to PD-(L)1 immune checkpoint inhibitors (ICIs) in patients with advanced non-small cell lung cancer (NSCLC). The project includes a comprehensive biomarker program with over 400 biomarkers and an umbrella clinical trial featuring four different ICI combinations.

The PIONeeR trial employed an innovative and adaptive design for trial reporting and decision-making to pinpoint signals of efficacy for new ICI combinations in advanced NSCLC patients who have become resistant to PD-(L)1 inhibitors.

Marseille, France, Sept 12, 2024 – The PIONeeR Project consortium announced that Pr Pascale Tomasini, the Principal investigator of the PIONeeR early phase randomized umbrella trial, will present initial data from the PIONeeR clinical trial at the ESMO Congress 2024, taking place from September 13-17 in Barcelona, Spain, and virtually. This presentation will occur during the Presidential Symposium III: Eyes to the future.

Prof. Fabrice BARLESI, coordinator of the PIONeeR Project and General Director at Gustave Roussy, as well as Professor at Paris-Saclay University, commented, "The PIONeeR trial is a collaborative success, fighting on multiple fronts to explore how to overcome resistance to PD-(L)1 inhibitors in advanced NSCLC. The clinical trial is now complete, and we are conducting extensive biomarker analyses that we hope will shed light on how to address this major challenge."

Prof. BARLESI also highlighted the dedication of the over 450 patients enrolled in the biomarker part of the PIONeeR Project and the more than 150 patients screened for inclusion in the clinical trial. "We are grateful for the dedication of our patients, which has taken us a giant step forward in advancing this study," he added.

Details on the abstract accepted for presentation at ESMO Congress 2024 include:

Presidential Symposium III: Eyes to the future
Title: Precision Immuno-Oncology for advanced Non-small cell lung cancer (NSCLC) patients with PD-(L)1 inhibitors Resistance (PIONeeR): a phase Ib/IIa clinical trial targeting identified resistance pathways
Presentation Number: LBA8
Presenter: Pr Pascale Tomasini, Aix Marseille Université, AP-HM, Early Phase Clinical Trials in Oncology Unit, Principal investigator of the PIONeeR early phase randomized clinical trial
Presentation Time: Monday September 16, 2024, 4:30 - 6:15 pm CEST

The abstract will be accessible on the ESMO website: ESMO Congress 2024 - Conference Calendar. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

The PIONeeR Project won the 3rd University-Hospital Research in Health call for projects in the “Investments for the Future program” and involves over 100 scientists across three countries, eight research labs, and 16 hospitals. The project has recruited 450+ patients for its biomarker program and 114 patients for the PIONeeR Phase Ib/IIa clinical trial. The clinical trial is now complete, and extensive biomarker analyses are ongoing. Partners of the PIONeeR Project include Marseille Immunopôle (MI), Aix Marseille Université (amU), Inserm, CNRS, four research and technology centers (CIML, CRCM, CIPHE, MImAbs), Assistance Publique-Hôpitaux de Marseille (AP-HM), the Paoli-Calmettes Institute, the Léon-Bérard Center, Gustave Roussy Institute, and industrial partners AstraZeneca, ImCheck Therapeutics, Innate Pharma, and Veracyte. This seven-year project has received French public funding (ANR-17-RHUS-0007).

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