Glenn Gundersen, Exact Sciences, Norway.

Gene profiling test for breast cancer approved

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A gene profiling test that predicts which breast cancer patients benefit from chemotherapy will now be adopted in Norwegian healthcare services.

After more than three years of processes in Nye Metoder (the national system of managed introduction of new methods in the specialist health care service in Norway), a gene profiling test for breast cancer patients was authorised on Monday morning. The test, offered by Oslo Cancer Cluster member Exact Sciences, can identify which breast cancer patients benefit from chemotherapy. The test was however only approved for breast cancer patients who are lymph node positive.

“We are surprised that we didn’t get approval for the largest group of patients, those who are lymph node negative. The Decision Forum considers that this group is already covered by Prosigna, even though Oncotype DX has very good documentation and is both cost-effective and cost-saving. So now Prosigna (which is not predictive for the use of chemotherapy) is given monopoly on a large group of breast cancer patients. This is incomprehensible across several countries. It seems almost like a misunderstanding. Normally competition is desirable,” said Glenn Gundersen, Exact Sciences, Norway.

Personalised treatment

There are about 4 000 new breast cancer cases in Norway every year and the number increases. Most patients receive chemotherapy after surgery, which can cause serious side effects, but not everyone has an added benefit from this treatment.

“This is about personalised treatment. Oncotype DX is a CE-marked gene profile test, consisting of 16 cancer-related genes and 5 reference genes. The genes have been selected because they have a prognostic and predictive value. This means the test can predict the potential benefit of chemotherapy for each patient’s tumour. These properties have been clinically validated in well-reputed large prospective randomised clinical trials.

“This represents an important advance in cancer precision medicine. We can more than halve the number of women receiving chemotherapy today. That means several hundreds, if not thousands, can be spared of chemotherapy side effects. It will have a dramatic impact if it is offered to lymph node negative patients as well,” said Gundersen.

A long process

Exact Sciences first sent the application to the Ordering Forum in June 2021. More than two years later, the Norwegian Institute of Public Health finished the health technology assessment of the product. However, it would take the Decision Forum another 10 months to decide on whether to approve the test for use in Norwegian cancer clinics.

“This is a no-brainer. Oncotype DX fulfils the three priority criteria: benefit and effect, use of resources, and disease severity. The health technology assessment states that between NOK 15 000 and 50 000 is saved for every patient, and for thousands of patients, it quickly adds up. Based on its strong documentation and value for the patient and the health care system, Oncotype DX should have qualified for a faster approval process,” adds Gundersen.

Based on UK data, an external evaluation group appointed by NICE (UK) reported that Oncotype DX could result in 594 fewer women having chemotherapy per 1 000 tested among N1 patients (patients with cancer spread to 1-3 lymph nodes in the axilla). The reduction for other gene profiling tests (Prosigna, EndoPredict) was 40. Oncotype DX is already in use in about 100 countries and has been tested in more than 1,8 million patients.

Privacy issues

With the advent of personalised cancer medicine, more gene profile tests are entering the market. This sparks legal and ethical questions about sharing Norwegian patients’ tumour tissue and health data with foreign commercial partners.

Gundersen explains: “Exact Sciences recognizes the sensitive nature of health data and the duty to guard its confidentiality. We pledge to maintain the highest level of privacy and security for our patients’ trusted information. Exact Sciences leverages advanced security expertise to safeguard sensitive medical data. We adhere to stringent legal frameworks like Data Processing Agreements (DPA) and Business Associate Agreements (BAA). These compacts are shaped by the mandates of the General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA), respectively, ensuring protection through compliance.

“Exact Sciences does not sell health information. We collect and use personal data for the singular purpose of performing laboratory tests as permitted by contract.

“The tumour specimens are sent by medical express courier to our laboratory in California, where a tiny fraction of the sample is used. In 7-10 days, the results are returned to the treating physician’s password-secured web portal and the remaining sample is returned. This means the Norwegian pathology departments don’t need to do any extra work, in fact, it may liberate capacity since they do not need to perform other local gene profiling analyses.”

 

The post Gene profiling test for breast cancer approved first appeared on Oslo Cancer Cluster.

Christian Jonasson, Research Director, and Steinar Thoresen, Medical Director, at NordicRWE are pleased to present the company's pioneering study into lung cancer immunotherapies. Photo: NordicRWE

NordicRWE reveals lung cancer immunotherapy study

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Three leading immunotherapy drugs against lung cancer demonstrated similar overall survival in a recent comparative study from NordicRWE.

The Norwegian start-up company NordicRWE has compared the effectiveness of three immunotherapies in second line treatment of advanced non-small cell lung cancer. The results indicate that the three immunotherapy drugs were equally effective in terms of overall survival.

“Lung cancer has historically been associated with a poor prognosis; however, new targeted therapies have significantly improved outcomes for these patients. Immunotherapies are among the new drugs introduced in Norway in recent years. The selection of the most appropriate drug for this specific indication has sparked considerable debate, particularly regarding efficacy and cost-effectiveness. We aimed to use our national registers and advanced statistical methods to answer these questions. We know that our national registers are of high and unique quality, well-suited to addressing these questions,” commented Steinar Thoresen, Medical Director at NordicRWE.

Using Norwegian health data

NordicRWE obtained extensive data from Norwegian health registries and applied advanced epidemiological methods and statistical analyses to emulate populations included in randomised clinical trials (RCTs).

“To introduce a cancer drug to the market, it is mandatory to provide evidence that the intervention is effective compared to current standard-of-care, but not to drugs being in the same drug class. As a result, head-to-head RCTs comparing the best treatments for the same condition are seldom conducted due to various reasons, such as cost, time and associated risk. This lack of comparative evidence from RCTs leads to an important evidence gap that we see can be replaced with using real-world data and advanced epidemiological research methods,” said Christian Jonasson, Research Director at NordicRWE.

“The study can be seen as a follow-up of the respective clinical trials in the real-world setting. Both patients and oncologists must ensure that the treatment administered is the most effective currently available on the market. To our knowledge, this is one of the first observational research studies that have assessed the comparative effectiveness of immunotherapies on lung cancer survival,” Thoresen added.

RWE in drug development

NordicRWE is actively engaged in real-world evidence, focusing on key areas such as the development of external control arms for clinical trials, comparative effectiveness and safety studies, and evaluating the representativeness of clinical trial populations and outcomes in real-world clinical practice.

“Real-world evidence is increasingly important in drug development and evidence generation for drug therapies. With this study, we hope to showcase the exceptional quality of Norwegian health data and demonstrate NordicRWE’s expertise in conducting rigorous epidemiological research studies. This is important with regards to establishing our solutions and services with both the global pharmaceutical industry and governmental bodies,” said Jonasson.

The current study was made possible due to a grant from The Norwegian Research Council.

The results will be presented as an abstract and oral presentation at the International Conference for Pharmacoepidemiology (ICPE) congress in Berlin on 27 August 2024. The full-length article is currently also under review with a leading journal in the field.

 

For more information, please contact: 

Steinar Thoresen, MD, Ph.D. Medical Director

Phone: +47 907 83 736

Email: st@nordicrwe.com

 

Christian Jonasson, MSc. Pharm. Ph.D. Research Director

Phone: +47 909 36 941

Email: cj@nordicrwe.com

The post NordicRWE reveals lung cancer immunotherapy study first appeared on Oslo Cancer Cluster.

Oslo Science Hub will provide an inviting and inclusive area for everyone on the Radium Hospital Campus and contribute to faster development of new cancer treatments. Illustration: Nordic Office of Architecture

New plans for the Radium Hospital Campus

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Article edit: On Tuesday 20 August 2024, an agreement was signed between Oslo City Council and Oslo Science Hub to sell the lots necessary for the building.

The planned buildings will transform the Oslo Montebello area into an international power centre for cancer research.

The drawings for Oslo Science Hub, the next expansion phase of Oslo Cancer Cluster Innovation Park, have been sent to Oslo City for approval and were recently presented at a meeting during Arendalsuka.

“Our vision is to create a vital and inclusive environment where researchers, entrepreneurs and companies at the Radium Hospital Campus can meet and collaborate to contribute to developing better cancer treatments,” stated Thomas London, CEO of Oslo Science Hub.

Thomas London, CEO of Oslo Science Hub, wants to contribute to developing new cancer treatments and offer a better environment for cancer patients and next of kin at the Radium Hospital. Photo: Sofia Linden

The new building will be 40 000 square metres, accommodate up to 2 000 employees, and offer state-of-the-art laboratories, complementary hospital services, biobank facilities and offices. There will be a mixture of tenants from the public and private sectors in health, oncology and biotechnology. The vision includes creating a “miniature village” with town squares, cafés, restaurants and shops to facilitate interactions between employees, patients and visitors.

A European power centre

“The Radium Hospital Campus is a European power centre for research, clinical treatment and innovation. We have a burning desire to develop the campus into a good place to do pharmaceutical research and development, to attract international key players, which are currently the missing link in the area,” commented Jónas Einarsson, founder of Oslo Cancer Cluster and CEO of Radforsk investment fund.

Oslo Science Hub will be built next to Oslo Cancer Cluster Innovation Park, the Institute for Cancer Research and Oslo University Hospital. Illustration: Nordic Office of Architecture

The Radium Hospital Campus already includes Oslo University Hospital, a Comprehensive Cancer Centre focused on innovation with its newly built clinic and proton centres. The area also encompasses the Institute for Cancer Research, which boasts solid research groups performing world-class research in several oncology areas.

Right next door is Oslo Cancer Cluster Innovation Park housing a mixture of public and private stakeholders, such as the Cancer Registry of Norway, Oslo University Hospital, and the Oslo Cancer Cluster Incubator with different start-ups and established companies.

A fourth building block is currently under construction, which will accommodate a restaurant, a cafeteria, a training centre, the non-profit organisations Active Against Cancer and Youth Cancer, and the international life science company Thermo Fisher Scientific.

Lack of space

“The area needs this type of building. We have been there for 30 years and are missing areas for expansion, special laboratories, and cafés and restaurants,” commented Geir Hetland, Chief Financial Officer of Thermo Fisher Scientific.

Thermo Fisher Scientific Norway was based on the Norwegian invention “Ugelstad-kulene” (later known as Dynabeads). The technology was developed in close collaboration with the Radium Hospital and today it is used in 5 billion diagnostic tests every year. Thermo Fisher Scientific need space to continue the company’s research and development in Norway.

Oslo Science Hub will bring laboratories, office spaces, biobank facilities and more, which will contribute to attracting international key players in research and development. Illustration: Nordic Office of Architecture

“We have spent an unnecessary amount of time through the years handling the lack of space for our companies. We have needs from start-ups, established companies and the hospital. I am happy we have built this ecosystem with all its positive dynamics and see that it is essential for start-ups to collaborate with international companies. So there needs to be further investments both on a national and local level for the health industry to succeed,” commented Ketil Widerberg, general manager of Oslo Cancer Cluster.

More than a hospital

For the patients, next of kin and health workers, these facilities are also sorely needed, since there are currently few places to meet, exercise, enjoy food or venture outdoors.

Sigbjørn Smeland, director of the Norwegian Radium Hospital, commented:

“My predecessor Jan Vincent Johannessen coined the term ‘more than a hospital’. This is clearly an extension of his work and shows that building culture and creating value over time releases good forces. We will offer the patient more than treatment for their cancer disease. This building is incredibly valuable in the totality we offer as a Comprehensive Cancer Centre.”

The new building will offer open and airy spaces for employees, visitors, patients and next of kin to meet and interact. Illustration: Nordic Office of Architecture

Ingrid Stenstadvold Ross, general secretary of the Norwegian Cancer Society, added:

“The most important thing is that the Radium Hospital is a spearhead in cancer care, that patients can get the best treatments available. The health services are also under pressure, meaning it is more important than ever to attract and keep skillful health workers. These facilities will help to do both these things.”

From words to action

Leader of the Oslo City Council Eirik Lae Solberg (The Conservative Party of Norway) made the campaign promise last year to ensure the sale of the real estate needed to build Oslo Science Hub.

“This is not a regular real estate issue. We need to prioritise this. We have a milieu that contributes to saving lives. From Oslo’s point of view, it is fantastic to have this industry. We have to support it if we want to be competitive in the future as a capital city,” Lae Solberg said.

Solveig Vitanza (the Labour Party of Norway), parliamentary representative, and Eirik Lae Solberg (the Conservative Party of Norway), leader of the Oslo City Council, promised their support to the development of the Radium Hospital Campus. Photo: Sofia Linden

Secretary General of the Ministry of Health and Care Services Cathrine Lofthus was also excited to see the plans taking concrete shape:

“I believe we need physical meeting places. We are not good enough at collaborating with the industry, but we hope to be better. This is exactly what we are talking about when we refer to the Roadmap for the Health Industry and Health as an Export Priority.”

Parliamentary representative Solveig Vitanza (Labour Party of Norway) expressed her ambition to go from words to action:

“We must facilitate the whole value chain: testing and piloting, clinical studies, clusters, health technology and data. We are in a very special time, with a recent pandemic and a geopolitical situation, which makes health a higher priority than ever.”

Watch the meeting here (in Norwegian):

Oslo Science Hub facts

  • Planned to be finished: 2030
  • Brutto area: 40 000 sqm
  • Potentially 2000 employees
  • State-of-the-art laboratories, complementary hospital services, biobank and offices
  • Mix of tenants similar to Oslo Cancer Cluster Innovation Park: public and private actors in oncology and biotechnology, especially international pharmaceutical industry
  • Open areas for the public, such as shops, restaurants, cafes and roof terraces

The Radium Hospital Campus facts

  • One of Europe’s largest campuses for cancer research and treatment
  • Consists of the new Radium Hospital, which opens in September 2024, the Institute for Cancer Research and Oslo Cancer Cluster Innovation Park and Incubator (OCCI)
  • Total building mass is 105 000 sqm
  • About 3 500 people work on the campus in different enterprises, while Ullern Upper Secondary School, which is an integrated part of OCCI, has 970 students
  • OCCI expands with 12 000 sqm that will be finished in 2025, which will include Thermo Fisher Scientific with several research departments, Active Against Cancer and some of the companies from OCC Incubator
  • A mix of public and private institutions that collaborate across organisations
  • Ullern Upper Secondary School have a school collaboration with other enterprises on campus, which includes placements and mentorships
  • Oslo Cancer Cluster Incubator with 16 start-up companies
  • A part of Oslo Science City, which is Norway’s first innovation district and an important part of Oslo City’s investment as a business capital

The post New plans for the Radium Hospital Campus first appeared on Oslo Cancer Cluster.

State Secretary Usman A. Mushtaq of the Norwegian Ministry of Health and Care Services and Parliamentary Representative Alfred Bjørlo (Liberal Party Norway) debated the future challenges on the health service at Fremtidens kreftbehandling during Arendalsuka 2024. Photo: Sofia Linden

Health – the next alerted crisis?

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New personalised treatments, investments in prevention, and integrating primary and specialist health services could contribute to averting a future health crisis.

“If we love Norway, we must also dare to change it.”

This statement was made by Alfred Bjørlo, parliamentary representative for The Liberal Party (Norway), at a recent meeting titled Fremtidens kreftbehandling during Arendalsuka. The topic for discussion was whether Norwegian health services are prepared for future challenges.

Bjørlo said: “We are going into a revolution in cancer care, from broad cancer treatments for big patient groups to precision treatment for individual cancer patients. It is a happy situation to be in, to have come so far in research and development of new treatments that we can save lives. But the revolution in the cancer field forces us to also re-evaluate how we rig the system.”

A higher demand

The Health Personnel Commission has concluded that with the changing demography, the future demand for health services will be larger than the resources available. They have suggested several measures to combat the crisis, including organisational changes, implementing novel technologies and increasing the number of health workers.

The newly appointed State Secretary Usman A. Mushtaq for the Norwegian Ministry of Health and Care Services commented in the debate:

“There is no doubt that the demographic development, the technology development and all other great changes happening in our society affect how we think about future health challenges and opportunities. At the same time, we must not forget that people’s expectations of us are also steadily increasing. Preserving the trust in the health services is incredibly important. We see challenges that will need tough prioritisation and health is something we will continue to prioritise.”

Cancer prevention & climate crisis

Mushtaq continued: “If we look at cancer, a disease area where we invest huge resources, there are more cancer cases and more survivors, but prevention does not get enough attention. Globally, it is estimated that a third of cancer cases are preventable. We can prevent cancer through lifestyle choices and vaccines. We cannot afford not to invest money in this area.”

Bjørlo agreed: “There are many things we must do in the field of prevention. For example, there are new dietary recommendations coming on Thursday. This also affects environmental and climate politics. A lot of this is connected. We need to make the right changes on the individual and system level.”

Gunnar Bovim, Head of the Health Personnel Commission, Chairman of the Board in the Norwegian Research Council and advisor in NTNU, emphasised seeing the health services more as one whole:

“It is important to see the whole patient pathway. A larger investment at the start can make the patient healthy enough to return to work. This has an enormous value.”

The health services as one whole

One model coming from Denmark is to have better integration between the primary and the specialist health services. Norway is characterized by many small municipalities, which makes the distances from university hospitals to small municipalities longer.

Bjørlo commented: “We have worked actively to reform the municipalities and make them larger. These are extremely challenging processes. There is too much silo thinking in Norway’s health services. A lot of amazing pilot work is happening in municipalities and health organisations, but we are too bad at putting them into the system and getting an effect. This is our responsibility as politicians, to dare to be clear about it. We need to be ready to make quite large structural changes.”

Mushtaq commented: “It is a good premise to have long-term investments in health. It is always more ‘sexy’ to invest in specialist health services, while primary health services often come in second place. Some will say that the specialist services get too much media attention, and it is up to us politicians to also prioritize the primary health services.”

The meeting was led by Thomas Axelsen from the Norwegian Cancer Society. You can watch a recording of the entire event (in Norwegian) below:

The Norwegian news outlets Medwatch and Healthtalk also covered the event and published articles in Norwegian here:

 

Fremtidens kreftbehandling is a meeting series organized by Oslo Cancer Cluster, The Norwegian Pharmaceutical Industry Association (LMI), The Norwegian Cancer Society, AstraZeneca Norway and MSD Norway.

 

The post Health – the next alerted crisis? first appeared on Oslo Cancer Cluster.