New clinical study will provide more cancer patients with targeted treatment

24 Sept

FOCU.SE is a new Swedish study in which genetic analysis of tumours is used to match cancer patients with targeted drugs outside of approved indication. The aim is to give more people access to effective treatment, while gathering valuable knowledge for the future.

In the national clinical study FOCU.SE, approved drugs will be tested on new patient groups with advanced cancer where treatment options have been exhausted. By analysing the genetic profile of the tumours, patients can be matched with targeted therapy. Even before the study has begun, four targeted drugs have been secured. More drugs will be included as the study progresses. As part of the Swedish government’s investment in precision health, the study is being funded with SEK 44 million.

“We are delighted with the support from the government which enables us to now launch the FOCU.SE study. With the FOCU.SE study, we can provide targeted treatments in a structured way to patient groups where it is otherwise difficult to conduct large drug studies, such as pancreatic cancer, bile duct cancer and sarcoma,” says Edvard Abel, medical director at the Clinical Trial Unit Oncology Sahlgrenska University Hospital and responsible for the study.

Digital collaboration on treatment decisions

A central part of the study is the so-called molecular tumour boards, where the results of the analyses are discussed to determine whether any of the study’s treatments may be suitable for the patient. The Molecular Tumor Board Portal (MTBP) tool – a digital platform and clinical decision support system for test results and data – will be used as support. With the help of this tool, doctors from different hospitals can participate in national conferences and discuss treatment options in real time.

The technical solution was first tested within the European research collaboration Cancer Core Europe and is now being adapted for national use in Sweden.

Patient council contributed to study protocol

Early on in the development of FOCU.SE, a patient council was formed, which has been active in developing study protocols and consent forms.

“We have shown how important it is for patients to be involved early on in the design of studies. Our commitment has also made it easier to include patients in the study”, says Margareta Haag, patient representative and chair of the Network Against Cancer:

Edvard Abel agrees:

“Working with the patient council has been time well spent and a great benefit to the entire project.”

Valuable knowledge for future treatment decisions

FOCU.SE makes it possible to systematically follow up on treatments outside of approved indications. This generates new knowledge about the effects and side effects of treatments – knowledge that can form the basis for future approvals and better treatment decisions.

In addition, FOCU.SE serves as a national platform for molecular testing, enabling patients to be identified more quickly for participation in other studies.

“The established collaborations for data sharing with similar studies provide entirely new opportunities to quickly answer research questions that are difficult to address in a single country. The ability to continuously add new drugs is also built into the study design. The broad genomic profiling that is carried out can both support clinical decisions and help identify patients for other studies. In this way, FOCU.SE, in collaboration with industry and international initiatives, can become a key to more clinical trials in Sweden,” says Anders Edsjö, senior physician in pathology at Region Skåne and deputy director of GMS.

About FOCU.SE

FOCU.SE has been developed within the framework of the Testbed Sweden Precision Health Cancer project, with funding from Vinnova and Swelife.
The project is backed by a broad consortium of stakeholders, including Genomic Medicine Sweden (GMS), SciLifeLab, university hospitals, the Swedish Institute for Health Medical Economics, the Stockholm School of Economics, industry partners and patient organisations.
FOCU.SE is being conducted at all university hospitals in Sweden, which means that patients from across the country can participate.
The study is a continuation of the work in the previous regional study MEGALiT and is being conducted in collaboration with several European countries within the EU projects PCM4EU and PRIME-ROSE, with focus on drug repurposing, i.e. evaluating existing drugs for new cancer indications.
The first four targeted drugs in the FOCU.SE study are Olaparib, Amivantamab, Tepotinib and Ivosidenib, all secured through collaboration within PRIME-ROSE.