The sustainability of the healthcare system is under extreme pressure, given the increasing costs associated with research, drug development, treatment and hospital care. Through support of its Investigators’ research and development activities, Oncode is working to advance new and innovative therapies to patients. In support of its goal to make healthcare more affordable, Oncode set up a dedicated call together with ZonMw to specifically fund projects with an affordable healthcare focus.

Medical oncologist Henk Verheul and physician-researcher Sophie Gerritse (Radboudumc), together with Oncode Investigator Jan Paul Medema (Amsterdam UMC) submitted a proposal and were recently awarded an €800.000 grant to support their project. With this money, they will conduct a clinical study into a new treatment with the existing anti-cancer drug sunitinib. Recent research by the investigators showed that with a higher dosage of sunitinib than traditionally delivered in first line therapy, a subset of patients with metastatic colon cancer see their tumor growth slow and decrease in size. Patients were able to tolerate this new dosage regimen, which administered the drug in a high dose once every two weeks, rather than a lower dose every day. The researchers are going to study this in a clinical trial.

Oncode spoke with Sophie Gerritse and Jan Paul Medema about the importance of their follow-up clinical study.

Why did you decide to work together and submit a proposal?
We initially came together to test out the idea that colorectal cancer subtypes would define the efficacy of sunitinib in a phase 1 trial via the Oncode Clinical Proof of Concept fund. Once we discussed our proposal during the first Proof of Concept workshop, it became apparent that our proposal to study this in a phase 2 set-up would fit the new affordable healthcare goals much better. sunitinib will go off-patent soon and if successful, we can stratify patients for therapy with an inexpensive diagnostic test, based on a biomarker for the CRC subtypes.

What is the goal of you project?
We aim to improve outcomes for patients with metastatic colorectal carcinoma, for which treatment options are extremely limited, by investigating the effect of high-dose intermittent sunitinib as an alternative therapeutic option. Next, we will try to correlate treatment responses to potential biomarkers and tumor characteristics to determine feasibility of upfront response prediction.

The overarching goal is to optimize therapy for the patients that are likely to respond to sunitinib.

How does this project contribute to the Affordable Healthcare goals of Zonmw and Oncode Institute?
By demonstrating superior outcome of our new treatment strategy for patients with metastatic colorectal carcinoma through extended survival and increased quality of life, we aim to repurpose this soon to be off-patent drug, thereby enabling both higher quality and more affordable healthcare.

Moreover, our project includes identification and assessment of potential (new) biomarkers for improved colorectal carcinoma diagnostics and treatment planning based on previous work on classifying colorectal cancer in different subtypes based on underlying biology. This subtype classification has the potential to be an inexpensive biomarker assay for identifying responders in clinical practice.

Did you get any support from Oncode during the call process and what was your experience?
Oncode supported us in setting up the Target Product Profile(s) (TPP). These are key strategic documents which are used to communicate summary requirements for (new) products that fulfil a priority need. This forced us to clearly think about our project, including primary and secondary aims and strengthened our proposal.

What are you most excited about within this project?
This project represents an ongoing and long-standing close collaboration between fundamental scientists and clinicians from multiple academic hospitals, who have the goal of contributing to the efficient translation of academic research into clinical practice. The research questions within this trial were determined by unmet needs in clinical practice. Thereby, this project can potentially provide immediate added value to patients with metastatic colorectal cancer for which treatment options are extremely limited. Furthermore, our studies on the obtained patient data and material include investigation of novel blood and tumor biomarkers, to enable future prognostic prediction for the future patients. Last but not least, we are possibly most excited by the fact that - with the help of Oncode - we have received the Bench to Bedside; Affordable Health Grant, enabling us to translate these plans into action and to determine whether we can improve care for this patient population.