Sweden eyes broader use of precision cancer medicine [Advocacy Lab Content]

Swedish researchers are preparing a national clinical trial to personalise off-label cancer drugs for patients who have run out of treatment options. The trial hopes to lead to a broad adoption of precision medicine in cancer care across Sweden.

Swedish researchers are now preparing to start a DRUP (Drug Rediscovery Protocol) clinical trial in Sweden in an attempt to discover potential new cancer medicines for patients with a bleak prognosis, and no other treatment options,

“Over the past 25 years, we have developed new methods to analyse the genetic and protein expression of tumours, map the mutations they contain and identify specific proteins that could be targeted. This knowledge has led to many new targeted therapies,” says Edvard Abel, consultant in oncology at the Sahlgrenska University Hospital in Gothenburg, and the medical director of the Swedish upcoming DRUP clinical trial.

The study was initiated by the Testbed Sweden Precision Medicine Health Cancer, a broad collaboration of key Swedish stakeholders such as Nollvision Cancer, Genomic Medicine Sweden, and SciLifeLab, which also involves authorities, researchers, pharmaceutical companies and patient representatives.

Today, precision medicine is unevenly accessible for patients with advanced or rare cancers across Sweden.

Repurposing cancer drugs

The collaborating parties hope that the study, called FOCU.se, will be the driving force for a national implementation of precision medicine in Swedish cancer care.

Abel told Euractiv: “We want to find out how we can use already approved drugs in new indications, in other tumour types. We could either test a drug against a specific mutation or against a basket of mutations.”

The trial will include around 1,500 adult patients with serious solid tumours who have not responded to standard treatments. They will be offered the chance to try one or maybe several approved cancer drugs on the market, initially approved for other tumour indications than their tumour type.

The launch of the clinical trial is planned for early next year if the European Medicines Agency and the Swedish Medical Products Agency give researchers the go-ahead. Discussions with global pharmaceutical producers are currently ongoing.

DRUP studies reportedly started in the US and were adopted in the Netherlands in 2016. So far, the results of the Dutch study show an increase in overall survival for about 30 per cent of patients, which translates to up to 11 months, with an average of nine months.

PRIME-ROSE precision medicine network project

For now, a handful of European countries have adopted similar DRUP trials, but some variant ones are also being conducted.

All of them are part of the EU-funded PRIME-ROSE precision medicine network project. The Swedish trial will also join.

The network uses powerful data processing techniques and has the ambition to share patient or mutation data and the efficacy of different cancer drugs between countries.

Cancer drugs are usually developed to target a specific type of cancer, such as breast cancer. However, the DRUP studies are based on the assumption that tumours, wherever they are situated in the body, can have a similar modus operandi or similar protein expressions or signalling pathways to gain growth.

By matching a tumour’s genetic and protein profile with potential off-label cancer drugs, the researchers hope to find more medicine that can shrink a tumour or slow its growth. They hope that in the future, more patients will be able to survive advanced or rare cancers.

Swedish patients’ last chance

Speaking to Euractiv, Margareta Haag, chair of the Swedish Network Against Cancer, an umbrella organisation for many cancer patient organisations in Sweden and responsible for the patient’s committee of the FOCU.se-trial, said that:

“This new DRUP study could be the last chance for Swedish patients. If 30 per cent survive for a longer period, as in the Netherlands, that would be fantastic and something we really would hope to see also in Sweden. But of course, it is a really sad situation for those patients who cannot be helped,” she says.

Overall, she hopes the trial will also lead to earlier and better diagnoses of advanced cancers and more personalised treatments.

New diagnostic methods

Dag Larsson, Senior Policy Manager at LIF, Sweden’s research-based pharmaceutical industry association, is also hopeful.

“If this project goes well, the plan is to build future cancer care on other types of diagnostic methods that are also important for the treatment of the patient,” he told Euractiv.

“Today, we have organised cancer care according to the type of tumour or the organ in which it is located. But this FOCU.se study means working in a new way. It may imply a major reorganisation of cancer care in Sweden because today we have rigged everything from the medical training of doctors to the organisation of cancer care to organ-based care,” he continued.

Dag Larsson sees two main advantages for pharmaceutical companies in joining the Swedish DRUP trial.

“The first one is that a growing proportion of new innovative cancer drugs introduced today require specific diagnostic tests to be used properly. In other words, it is about applied precision medicine where each patient is offered the most appropriate medication,” he told Euractiv.

The second benefit, according to Larsson, is that the data generated by the trial may reveal new indications for an old drug that a company may exploit commercially.

Around ten pharmaceutical companies are interested in participating in the project. They are needed to supply the patients with cancer drugs used in the clinical trial.

The Swedish clinical study will shortly apply for ethical approval from the European and Swedish authorities.

[By Monica Kleja, edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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