Paris, November 23, 2018

French oncologists rally to promote innovation for patients, accelerate evaluation, and expand access

At the 5th Cancer Innovation Conference, which brought together more than 400 participants, the attending physician-researchers commended the efforts of health authorities and agencies to restore France’s international competitiveness in the field of clinical research—particularly early-phase trials—and to accelerate patient access to innovation. In oncology, the role of breakthrough innovations in the patient care pathway is unparalleled in any other discipline.

The year 2018 marked a major milestone in the evolution of legal and regulatory measures and frameworks governing innovation in healthcare (CSIS measures, the ANSM action plan, an amendment to the Jardé Law regarding the random selection of CPPs, the extension of ATUs, early coverage of medical devices, etc.). France now has the assets to enhance its appeal. “These measures will have a positive impact on the French clinical research ecosystem and the resulting medical challenges,” comments Prof. Jean-Yves Blay, Director General of the Léon Bérard Center, “but we must remain extremely vigilant regarding the implementation of action plans and resources, as well as their timelines for effective implementation, because it is necessary to consolidate them, following the example of the CLIP² centers accredited by INCa through 2019.”

“Innovative treatments provided as part of clinical trials, including early-phase trials, are part of a broader effort to improve the patient journey. “There is no longer a boundary between care and research,” emphasizes Prof. Gilles Vassal, Director of Clinical Research at Gustave Roussy; access to innovation—whether for new molecules or molecular tests—underpins the principles of precision medicine and the new therapies that are currently revolutionizing previous treatment paradigms, such as immunotherapy.”

Against the backdrop of a major acceleration in scientific knowledge about cancers, more than 900 new drugs are currently in development worldwide (including 84 that received FDA approval versus 37 EMA approvals in 2017 and 2018). Early-phase trials (targeted therapies, immunotherapy antibodies, various combinations, etc.) now provide significant clinical benefit for patients who have failed standard treatments (20% response rate [Chakiba et al. NEJM, 2018] and more than 50% achieving prolonged disease stabilization). These results are achieved through so-called precision medicine guided by biomarkers using validated molecular tests, the costs of which are not covered. France’s role in these strategic trials therefore remains limited, with 244 trials currently open compared to 710 in Europe and 2,143 in the U.S. [clinicaltrials.gov], and its appeal continues to be threatened by delays in evaluation and market access.
 
Strengthening France’s competitiveness, as well as shifting the balance between standard care and innovative care in favor of the latter, has an impact on the organization of the healthcare system, as it requires establishing at the national level a limited number of specialized centers with thethe expertise and sufficient critical mass to provide innovative care—ideally through regional networks—and working in close collaboration with industry partners.

Academic clinical research professionals must also, as quickly as possible, become key partners in structuring and professionalizing French expertise in innovation and contributing to an ambitious and visionary health policy. “Physician-researchers propose to organize their expertise to inform future strategic decisions and promote the voices of the coordinators of these innovative trials to regulatory bodies and agencies,” comments Prof. Fabrice Barlesi, Coordinator of the Marseille Early-Phase Cancer Trials Center, AP-HM, noting that, as things stand, regulatory agencies focus on a singular relationship with industrial sponsors and other stakeholders in the healthcare sector at the expense of leveraging national scientific expertise.

About the Cancer Innovation Meetings

Organized by Gustave Roussy’s Department of Therapeutic Innovation and Early-Phase Trials since 2010, the Cancer Innovation Meetings will take place this year on November 23 in Paris, at the Salle Wagram. This biennial event, which brings together innovation stakeholders and government agencies for roundtable discussions, provides an opportunity to discuss patients’ access to innovation in oncology.

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