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Norwegian cancer initiatives receive international attention

Norway is pioneering precision medicine in cancer with three nation-wide initiatives.

Norway is breaking new ground for precision cancer medicine implementation with three national initiatives that are highlighted in the latest issue of the academic journal Nature Medicine. The article shows the broad stakeholder involvement in the initiatives with 116 contributors with 80 different affiliations.

Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital (OUS). Photo: OUS

Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital (OUS). Photo: OUS

“These initiatives represent a triple-win effect,” said Kjetil Taskén, Head and Director of Institute of Cancer Research at Oslo University Hospital and Professor at University of Oslo. “The patients gain access to modern treatments; the researchers can investigate the effect of different medicines on new indications; and the industry can expand the application of their drugs.”

The three initiatives

  • InPreD is a service for precision diagnostics organised as a national infrastructure within the specialist health service. 
  • IMPRESS-Norway is a nation-wide clinical trial evaluating the efficacy of anti-cancer drugs on new indications. 
  • CONNECT is a consortium of public and private stakeholders driving the implementation of precision cancer medicine in Norway. 

Precision diagnostics for patients

Recent developments in precision medicine offer new medical opportunities for cancer patients, which has ignited a debate in Norway about access to more modern treatments. Though equal access is ensured through Norway’s universal health coverage, the medical possibilities challenge public budgets and has led to delayed access for some patient groups.

“There is a growing, worrying split in the health service, where some patients feel compelled to buy diagnostics and treatments at private clinics, when the opportunity does not exist in the public sector,” said Ingrid Stenstadvold Ross, General Secretary of the Norwegian Cancer Society. “These initiatives are spearheading new solutions for seriously ill cancer patients, wherever they live in Norway, and demonstrate what is possible to accomplish with public-private collaboration.”

Norway is one of the first countries in Europe to have a reimbursement scheme, with additional financial support from the regional health authorities to hospitals, for the gene panel test via InPreD. The infrastructure is being set up at all university hospitals in Norway and patients from all Norwegian hospitals can be referred to InPreD. It is currently only available to patients with no other treatment options. The results from the test are discussed in a weekly molecular tumour board that refers patients to clinical follow-up, IMPRESS or other clinical trials.

Åslaug Helland

Åslaug Helland from Oslo University Hospital presented IMPRESS-Norway at Nordic Precision Medicine Forum 2022 in Stockholm. Photo: Åsmund Flobak

InPreD has screened more than 359 patients, of which 67 patients have been included into treatment cohorts in IMPRESS, as of April 2022. An additional 10-15 per cent of screened patients have been assigned to another clinical trial or drugs through compassionate use programmes. This means about 40 per cent of screened patients have received a new treatment option.

“This is about leaving no stone unturned, about finding drugs for patients who wouldn’t have gotten it otherwise. We want to serve the needs that the patients have in terms of modern treatments in the public healthcare system,” said Taskén.

Clinical trial offers new hope

There are currently 16 drugs available in IMPRESS and the goal is to include 23 drugs by the end of 2022. The first pharmaceutical company to join was Roche, providing eight drugs in January 2021. Novartis entered IMPRESS as second partner in 2021, now contributing four cancer medicines.  

“These initiatives offer patients who have exhausted available treatments, a chance for new treatment options and hope,” said Eli Bergli, Medical Head Oncology, Novartis Norway. “Novartis is proud to be part of the implementation of precision diagnostics, so patients can receive a tailor-made treatment for their disease. These innovative partnerships, where public sector, academia and private industry collaborate in finding the best solutions for the future of healthcare, are ground-breaking and offer patients early access to new innovative treatments.”

“InPreD, IMPRESS and CONNECT are core initiatives for the implementation of precision medicine in Norway, and Roche is a proud partner,” agreed Kristin Krogsrud, Healthcare System Partner, in Roche Norway. “In addition to the important goals of establishing genetic testing in clinical practice and generation of scientific data, we see the work around development and piloting novel reimbursement methods as key to be able to improve patient’s access to personalized treatment.”

The four Norwegian regional health authorities recently decided to reimburse drugs in Stage 3 cohorts in the IMPRESS trial. The pharmaceutical industry pays for the first 16 weeks and, if the patient achieves a response after 16 weeks in the trial, the treatments can be reimbursed permanently from the public healthcare system. This is the first mechanism for a pay-for-performance model in precision cancer medicine in Norway ever.

Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority.

Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority.

“We have had a great and close collaboration with the hospitals in the establishment of a national infrastructure in the Specialist Health Service for precision diagnostics in the cancer field (InPreD),” said Jan Frich, Deputy Chief Executive Officer at South-Eastern Norway Regional Health Authority. “The high inclusion numbers in the IMPRESS-study after referral from InPreD confirm that we are on the way to succeeding in establishing the necessary ecosystem for advanced diagnostics and clinical studies in the Specialist Health Service. This is something we are very proud of.”

Connecting public with private

The third initiative is CONNECT, a public-private consortium consisting of 28 partners, with Oslo Cancer Cluster being the project coordinator. The common goal is to drive the implementation of precision cancer medicine in Norway.

“Oslo Cancer Cluster is a neutral facilitator and an intermediator between public and private. They have been with us since we started working on these national initiatives. Among other things, Oslo Cancer Cluster has been a great supporter in bringing in the pharmaceutical companies in IMPRESS,” said Taskén.

The Norwegian Health Directorate is one of the observers in CONNECT and a coordinator for the National Strategy for Precision Medicine. 

“We follow the work in CONNECT with great interest as it investigates new ways of implementing precision medicine,” said Grethe Foss, Project Leader for Precision Medicine at the Norwegian Health Directorate. 

Taskén stresses one reason for the success of these initiatives is that they are not about profiling individual institutions or people but about coming together with shared objectives. 

“There has been trust and we have been able to act together. The fact that these initiatives now receive international attention can hopefully lead to an expansion of our efforts, that more companies and institutions join, so that more cancer patients gain access to the cancer treatments of the future.”

 

Learn more

Content looking woman to the left and man to the right, head shots put together

Eli Lilly & Company in the IMPRESS study

Eli Lilly & Company is now part of the national Norwegian IMPRESS study.

Eli Lilly & Company is already part of CONNECT, the national collaboration on implementing precision medicine in Norway. Now, the international pharmaceutical company is offering participants of the IMPRESS study a new and promising medicine. This is good news for cancer patients in Norway.

Read more about CONNECT on their website.

The IMPRESS study is a national clinical study looking into the effect of cancer precision medicine. Patients with advanced, incurable cancer will – through the study – get the opportunity to test new treatments for their type of cancer.

Finding new and effective forms of treatment

The goal of the IMPRESS study is to test whether so-called off-label medications can be effective on new patient groups, based on their type of cancer and genetic mutations (molecular profile). This means that the participants of the study are testing out medications approved for the treatment of other diseases to fight their specific cancer disease. In other words, it’s not the type of cancer, but the genes that determine which medicine the patient receives.

“Impress is an important study for Norwegian researchers, not to mention for Norwegian cancer patients,” said Lars-Petter Strand, Medical Director Oncology in Eli Lilly Norway, in a press release from the company.

The intention is to find effective forms of treatment adapted to each individual’s cancer – a form of precision medicine. CONNECTs partner, Eli Lilly & Company, is now offering the participants of the study a new medication. This is great news for all the participants.

Up to 24 patients

Eli Lilly & Company is giving up to 24 participants the opportunity to try out the lung cancer medication Selpercatinib, sold under the product name Retsevmo. In previous studies, this medication has shown very good effects.

In order to treat as many patients as possible, access to medication is crucial. A wider range of medications to test contributes to more patients being able to receive treatment. Eli Lilly & Company’s support for IMPRESS is therefore of great importance.

“We are thrilled that Lilly supports IMPRESS Norway! We are seeing very good effects from the use of Selperkatinib through the completed studies, and we are pleased to be able to offer this medication to the patients participating in the IMPRESS study,” said Åslaug Helland Nasjonal, Project Leader for IMPRESS-Norway, in the press release.

In the same press release, Lars-Petter Strand emphasizes the importance of the IMPRESS study.

“Impress is an important study for Norwegian researchers, not to mention for Norwegian cancer patients, where the benefit and risk of tumor agnostic-targeted treatment will be investigated,” Strand said, and added:

“IMPRESS also emphasizes the importance of the hospitals and the pharmaceutical industry having an open dialogue about data and research, in order to contribute to the best possible treatment for Norwegian cancer patients.”

Novartis enters IMPRESS

One of the largest pharmaceutical companies enters the precision cancer study IMPRESS in Norway.

Access to a broad portfolio of different medicines that can match molecular findings in a patient is important to succeed with the precision medicine approach of IMPRESS, Norway’s largest cancer study.

“We are very happy that Novartis is now contributing several of their medicines in the IMPRESS-Norway study. This means that Norwegian cancer patients can have more treatment opportunities in the study and that we can treat more patients based on molecular diagnostics. Novartis has many very interesting medicines. We count on more companies joining the study with their medicines soon,” said Åslaug Helland, National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Åslaug Helland is looking into the camera with a content smile, wearing a blue jacket and glasses.

Åslaug Helland is National coordinator for IMPRESS-Norway and Head of Research at Oslo University Hospital.

 

Six new medicines

Novartis is happy to support the IMPRESS study with six of its cancer medicines to treat up to one hundred patients. The first two Novartis medicines are ready for use this summer and the last four will probably be introduced during the autumn.

A broad collaboration with pharma partners for IMPRESS is important, both to Norwegian cancer patients who have run out of other treatment options, and to build stronger collaborations between public and private actors in the healthcare sector.

“Novartis is proud to contribute to the solutions of the challenges we are facing in the health ecosystem, including the implementation of personalized medicine. Through IMPRESS-Norway and the public-private collaboration in CONNECT, we wish to contribute to a culture for innovative and trusting partnerships with the health service – partnerships that are greater than the capacity and resources of each side alone. We are stronger together,” said Tarje Bergdahl, Nordic Medical Director Oncology Novartis.

Testing off-label treatments

IMPRESS-Norway is a national clinical study in precision cancer medicine, which is testing off-label treatments on cancer patients based on molecular changes in the patient’s tumour. Patients with advanced cancer disease can receive molecular diagnostics through InPreD (Infrastructure for Precision Diagnostics) and are discussed in a national molecular tumour board to provide optimal treatment for the individual patient. Patients who are eligible for the treatments available in IMPRESS are then offered to participate in the clinical study.

All the Norwegian hospitals that are treating cancer patients are part of IMPRESS, in total 17 hospitals, including the university hospitals. Of these sites, 8 are currently open for the study, the rest are opening in August and September. As of 1 July, 40 patients were included in the molecular profiling with a 500 gene panel, 18 patients were discussed in the national molecular tumour board and 7 patients were included with different treatments in the IMPRESS study.

Read more

  • The consortium CONNECT is linked to the clinical study IMPRESS and the Infrastructure for Precision Diagnostics InPreD. CONNECT has facilitated dialogue meetings between industry representatives and the two mentioned national initiatives IMPRESS and InPreD. CONNECT is coordinated by Oslo Cancer Cluster. Read more about CONNECT, the partners and recent activities here: The CONNECT website
  • Dagens Medisin has written about Novartis entering IMPRESS (in Norwegian) here: Flere legemidler tilgjengelig i IMPRESS-studien

 

First pharma company joins IMPRESS-Norway

Roche is the first pharmaceutical company included in the national clinical study in cancer precision medicine called IMPRESS-Norway.

IMPRESS-Norway is a national clinical trial in precision oncology. Approved drugs will be used to treat new cancer indications (“off label”) based on the molecular profile of the patient’s tumour. The success of IMPRESS-Norway is dependent on molecularly targeted drugs contributed by pharmaceutical companies. Roche is the first company to officially join IMPRESS-Norway. The company will contribute eight different medicines and provide a diagnostic gene test through its subsidiary Foundation Medicine.

“Positive and important news that Roche wishes to contribute their resources. Now, this will be a joint investment in both diagnostics and treatment, so that precision medicine for advanced cancer disease can be offered at all hospitals in Norway. We are very happy that Roche wishes to participate in this initiative,” commented Egil Støre Blix, oncologist at the Cancer Department at the University Hospital of North Norway and member of the Trial Management Committee at IMPRESS-Norway.

IMPRESS-Norway is in dialogue with several other pharmaceutical companies about contributing cancer medicines. These companies have also joined CONNECT, the newly established public-private partnership initiated to accelerate the implementation of precision medicine for cancer patients in Norway (see the fact box below for a complete list of CONNECT Founding Partners).

“The CONNECT partnership and IMPRESS-Norway are important milestones in the implementation of personalised medicine and will drive the development of a more personalised health service,” commented Ingvild Hagen, Area Owner for Personalized Healthcare in Roche. “We hope that in signing the IMPRESS agreement, we are motivating other companies to do the same. To realise the potential of this project, we are dependent on as many partners as possible. We are definitely stronger together!”

Oslo Cancer Cluster has played an active role in setting up the initiatives IMPRESS-Norway, CONNECT, InPreD and INSIGHT, to gather the Norwegian oncology community with the common goal of getting cancer precision medicine faster to Norwegian patients.

Ketil Widerberg, General Manager at Oslo Cancer Cluster. Photo: Stig Jarnes/Oslo Cancer Cluster

Ketil Widerberg, General Manager at Oslo Cancer Cluster. Photo: Stig Jarnes/Oslo Cancer Cluster

“Cancer is a genetic disease. However, we often treat according to where in the body the cancer is discovered and not based on the genetic profile. This changes now when technology and medicine are merging in precision medicine. Roche is one of the companies that has come furthest in this development. Their involvement in IMPRESS and CONNECT is highly appreciated. This is an important milestone, and we look forward to more companies following their example,” commented Ketil Widerberg, General Manager, Oslo Cancer Cluster.

Precision medicine is about providing the right treatment for the right patient at the right time. There are many cancer therapies today that can be targeted towards specific molecular changes in the cancer cells. Patient access to molecular diagnostics is one of the prerequisites for the successful implementation of precision medicine.

Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway. Photo: Mathilde Oseberg

Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway. Photo: Mathilde Oseberg

“The establishment of broad genetic testing is essential to offer patients our treatments in clinical studies and IMPRESS drives the implementation of this in Norway. For patients whose tumour tissue isn’t available, the contribution from Roche through Foundation Medicine is of great importance to examine whether blood can replace tissue when identifying relevant biomarkers,” commented Randi Hovland, Head of Section for Clinical Genetics at Haukeland University Hospital and member of Trial Management Committee in IMPRESS-Norway.

IMPRESS is based on the DRUP (Drug Rediscovery Protocol) trial in the Netherlands, a precision medicine trial evaluating the effects of a broad portfolio of precision treatments based on the molecular profile of the patient’s tumour. The benefits of this study were highlighted by Emile Voest, Medical Director of The Netherlands Cancer Institute, at the recent Cancer Crosslinks. The  learnings from IMPRESS and related trials will be discussed in CONNECT and are important to develop novel implementation models for cancer precision medicine.

Read more about CONNECT, InPred and INSIGHT here: Landmark public-private agreement for precision cancer medicine

 

CONNECT Founding Partners:

  • Akershus universitetssykehus HF
  • Helse Bergen HF
  • Helse Stavanger HF
  • Olavs hospital HF
  • Universitetssykehuset Nord-Norge HF
  • Oslo Universitetssykehus med Kreftregisteret og OUH Comprehensive Cancer Center
  • Folkehelseinstituttet
  • Oslo Cancer Cluster SA
  • Kreftforeningen
  • Legemiddelindustrien
  • Roche Norge AS
  • Bristol-Myers Squibb Norway Ltd NUF
  • Novartis Norge AS
  • Merck AB NUF
  • Takeda AS
  • Amgen AB Norge NUF
  • AstraZeneca AS
  • AbbVie AS
  • Bayer AS
  • PubGene AS
  • Pfizer Norge AS
  • NEC Corporation

 

Please get in touch with Jutta Heix, Head of International Affairs at Oslo Cancer Cluster, to learn more about our initiatives in precision medicine and how to join CONNECT.