Personalised oncology: innovative people centred, multi-modal therapies against cancer

In addition to contributing to Europe’s Beating Cancer Plan, the Mission on Cancer, the EU Industrial and Pharmaceutical Strategy, and implementation of the Sustainable Development Goals of the United Nations, the work supported under this topic will help to achieve several of the expected impacts from IHI specific objective 2: “Integrate fragmented health research & innovation (R&I) efforts bringing together health industry sectors and other stakeholders, focusing on unmet public health needs, to enable the development of tools, data, platforms, technologies and processes for improved prediction, prevention, interception, diagnosis, treatment and management of diseases, meeting the needs of end-users.”

Specifically, it will do this by doing the following:

• Breaking down fragmentation between various disciplines of medicine and technological areas in order to conceive and develop technologically and socially innovative, people-centred, integrated healthcare solutions that can seamlessly be introduced in healthcare systems.
• Fostering the development of safe and effective innovative health technologies and their combinations thanks to new and harmonised approaches to data generation.
• Better and faster integration of future products, services and tools along the healthcare pathway responding to patients’ specific needs and leading to improved health outcomes and patient well-being.

Moreover, the work supported under this topic will also contribute to some expected impacts from IHI Specific Objective 3: “Demonstrate the feasibility of people-centred, integrated health care solutions.”

• Patients benefit from treatment and care better adapted to their needs through improved diagnostics, prognosis and monitoring their quality of life while on and beyond treatment.
• Integrated health care solutions, including those based on the use of digital solutions, better responding to the needs and preferences of patients and healthcare providers through an inclusive approach.
• Successful implementation of digital solutions supporting people-centred care.

R&I actions to be supported under this topic shall contribute to all the following outcomes:

Platform, standards and regulatory

• A versatile and dynamically evolving platform for R&I collaboration across sectors, between academia and industry partners with a focus on the early stages of applied clinical research on cancer.
• Cancer healthcare pathway standards to enable personalised treatment and joint registries.
• Demonstration of how the benefits of health technology convergence can be harnessed in line with all relevant regulatory frameworks in Europe.

Improved multi-modal therapy

• Health innovations in cancer therapy through development, testing and validation of multi-modal therapeutic approaches including novel or emerging technical and clinical concepts and potentially supported by in vitro diagnostics.
• Personalised therapeutic options for cancer patients to improve outcomes, including shared information and integration of various specialised clinicians as well as shared decision-making for treatment and care.
• Improved active monitoring and adaptation of therapy through the patient journey, involving early-response biomarkers and evaluation of their predictive power and correlation to clinical outcomes, as well as more involvement of patients in the cancer patient journey.

Different treatment modalities are available for various cancers, however, the differing biology of cancers as well as the differing efficacy of treatment modalities dictate rather patient-specific approaches. Multi-modal therapies have been shown to be of high value in this respect and there is a strong need to increase the therapeutic arsenal of such multi-modal therapies and to tailor the treatment approach to the individual patient.

The aim of this call topic is biomarker-guided multi-modal precision oncology based on imaging, phenotype, genomics, in vitro diagnostics, co-morbidities, clinical and real-world data.

Proposals should facilitate the development of new health technologies and integrate them with (possibly adapted) current therapy concepts, to create and explore multi-modal therapies personalised to the needs of the individual patient. Applicant consortia should pursue different therapeutic strategies and combine at least two cancer treating modalities¹ (supported by a sound scientific rationale in the application).

The proposed R&I activities should include development of research protocols for multi-modal therapies expected to have a significant potential to create patient benefits. These protocols should be explored via early clinical studies with sufficient sample size and statistical power to assess safety and efficacy and demonstrate feasibility of the chosen multi-modal approach.

Depending on the specific therapies to be studied and combined, the R&I activities should consider the clinical decision-making process aspect among the various disciplines involved. They should also include the evaluation of aspects such as the sequencing, timing and dosing of therapies to maximise treatment effects with minimal toxicity and normal tissue complications. It is expected that the use of prognostic and predictive biomarkers and the combination of diagnostic tools to plan and adapt treatment and evaluate treatment and the follow up of patients will be a key component of the proposed integrated healthcare solutions.

To overcome the barriers to cross-sectoral collaboration, proposals need to consider methodologies and standards for the combination of various technologies into integrated healthcare solutions. Furthermore, proposals should also consider the design and conduct of clinical studies of multi-modal therapies and methods to evaluate their safety and clinical benefits.

Proposals should include a description of how data will be generated, captured and stored, and how it will be used in line with the FAIR² principles and sustained to promote collaboration among stakeholders. Proposals should enable secure, GDPR³ compliant and interoperable access of the data.

^{1 Pharmaceutical, nanotechnology, radiology or other therapeutic approaches (e.g. small molecules, hormone-, cell-, or immuno-therapy, drug delivery systems and nanoparticles, radio-ligand therapy, adaptive radiation therapy with guided dose optimisation, altered dose fractionation schemes including hypo-fractionation, ablation and radio-surgical concepts based on photon or charged particle radiation including FLASH (irradiation at ultra-high dose rates, several orders of magnitude higher than conventional dose rates), theranostics and radiopharmaceuticals).}

^{2 Findable, Accessible, Interoperable, Reusable}

^{3 General Data Protection Regulation}