‘Oncode Accelerator places patients at the center of the development process’

In this interview, Geraldine explains why and how Oncode Accelerator places patients at the center of the development process of new cancer therapies.

How are patients currently included within the pre-clinical development of new cancer therapies?

“Currently, developing new cancer medication takes approximately 20 to 30 years, and there's a high failure rate. Patients come into play during early clinical trials, the so-called phase 1 and phase 2 trials. Oncode Accelerator aims to involve the patient much earlier in this process compared to the current practice, by using data and material from well-defined patient cohorts. Patient cohorts have access to extensive clinical data and patient materials like tumor tissue and blood samples. This data aids in target discovery, lead finding, and lead validation. We believe that by utilizing this material and data earlier in the development process, we can better identify which patient populations can be treated effectively with which kind of medication.”

What role will the patient cohort platform have within the program?

“Within Oncode Accelerator, we aim to accelerate the preclinical development of cancer therapies. By using specific patient material and rich clinical data, we believe we can better select effective therapies and identify the patient subgroups that will benefit. By setting up the cohorts and proceeding to the clinical phase, we can determine which patients could be eligible for those clinical studies and inform their treating physician. Also, by integrating data from preclinical studies with AI-modelling and organoids, we can design phase 1 studies more intelligently, using adaptive clinical trial design. This approach allows us to learn more from the clinical studies we conduct and apply that knowledge during the preclinical phase, creating a learning loop.”

How will the Patient Cohort Platform help to improve the options for personalized treatment for cancer patients?

“Currently, when a medical oncologist prescribes a drug, they often don’t know whether it will be effective. A drug may be effective in 60% of the patients seen in daily clinical practice, for instance. There are a number of reasons for this. One of them is that only a small percentage of the patients can participate in phase 2 and phase 3 studies. These patients are typically people who are younger and fitter, not very representative of the entire patient population. In addition, every tumor is different and has a unique molecular make-up. That’s why we need good biomarkers to better select the patient population for whom the treatment will be effective. With patient cohorts, we have data from a diverse patient group, allowing us to select either a broad patient population or a smaller group with specific mutations for our tests. This will help us in the search for good biomarkers and better defining for which patients the medication will be effective.”

How is patient privacy handled within Oncode Accelerator?

“Patient privacy and the privacy of the hospitals are paramount. We have a study protocol where we specifically outline how we use patient data and how we handle it, which is also approved by the medical ethical committee. All clinical data and patient materials are coded with a study code, and only the central study team and the treating physicians know the identity of the patient. We don’t use anonymous data and materials because in case significant results emerge during the tests, both the patient and physician need to know. Patients give informed consent because they want to improve outcomes for future patients in both overall survival and quality of life.

How does the adaptive design of patient cohorts work within Oncode Accelerator?

“Typically, within clinical trials, we run a study, and the results are obtained at the end. The aim of early clinical trials with an adaptive design is that we already learn during the study and can adjust it based on the results during the study. Learning along the way is essential in this kind of design. Prerequisite for this is that the data needs to be obtained almost real-time, and endpoints must be determined quickly. For instance, waiting for three years for overall survival is not feasible, since learning during a study would be impossible. Therefore, careful upfront planning, including a statistical plan and considering how quickly clinical data can be obtained and endpoints reached, is necessary when creating an adaptive design.”

What challenges do you foresee in the future?

“What I find exciting is that we have a diverse range of stakeholders in this program, including scientists, clinicians, and private companies, all working together towards the same goal. The Netherlands has a strong reputation for collaboration among different stakeholders to achieve a common objective. Naturally, challenges will arise when working with various organizations, but I am confident that we will overcome them because we are united by a shared goal.”