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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.

IMPRESS leads the way for cancer precision medicine

IMPRESS Norway is a national clinical study starting in 2021 working towards implementing cancer precision medicine in Norway.

As one of the initiators behind IMPRESS-Norway, Oslo Cancer Cluster is thrilled to see this national clinical study in cancer precision medicine become a reality.

Precision medicine is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease, according to the National Cancer Institute.

During 2019, Oslo Cancer Cluster hosted a series of workshops with public and private stakeholders in cancer. The joint goal was to accelerate the implementation of cancer precision medicine in Norway. The initial idea for IMPRESS emerged in one of these workshops. A dedicated team, including Kjetil Taskén, Sigbjørn Smeland, Åslaug Helland and Hege Russnes, at Oslo University Hospital quickly turned it into a national effort together with colleagues at university hospitals across Norway.

IMPRESS involves the active support of leading global pharmaceutical companies that will provide the study drugs and contribute with per patient fees. Public funding will help to ensure this innovative study paves the way for more cancer clinical trials in Norway.

National infrastructure for precision diagnostics is needed and is currently being set up at all Norwegian cancer hospitals. Cancer patients who are eligible for clinical trials can soon be tested and selected based on their specific genetic profile.

A new public-private partnership called CONNECT is also being established with Oslo Cancer Cluster as project coordinator. CONNECT will provide an arena for all stakeholders to jointly address key obstacles and to pilot novel solutions to advance the implementation of precision cancer medicine.

In the newly released Norwegian state budget, an additional NOK 30 million is allocated for personalized medicine. NOK 25 million is earmarked for the implementation of genetic precision diagnostics at the Norwegian hospitals. This demonstrates a commitment from the Norwegian government to advance the implementation of precision medicine for Norwegian cancer patients.

Learn more: Read the article (in Norwegian) at Oslo University Hospital’s website or the English translation below.

 

IMPRESS NORWAY: Large national precision medicine study in cancer

IMPRESS-Norway, a large national study on precision medicine against cancer, starts in the beginning of 2021. The study will, based on individual and expanded gene analysis give its participants the opportunity to receive so-called off-label medicines, that is medicines approved for the treatment of other diseases, to fight their specific unique cancer disease.

IMPRESS-Norway is a national clinical cancer study in precision medicine. The goal with the study is to test approved pharmaceuticals on new patient groups based on their cancer type and genetic mutations (molecular profile). The study is open for all hospitals in Norway that treat cancer patients and so far, thirteen hospitals have decided to participate in the study.

In the study, we will, in addition to data on clinical efficacy, collect comprehensive information about the molecular changes in the cancer tumour, by performing a complete DNA analysis, whole genome sequencing. This will provide us with a unique and comprehensive dataset that can be used by researchers across Norway to answer key questions in cancer treatment, such as improving the selection of patients for treatment and understanding resistance mechanisms.

For patients with advanced cancer who have received standard treatment

Patients with advanced cancer who have already received standard treatment are eligible to participate in IMPRESS-Norway, and we expect between 250 and 500 patients to be recruited every year. The patients will be included in patient groups (cohorts) based on molecular profiles, cancer diagnosis and medicine. Each cohort will first include eight patients. If one or more patients respond to the treatment, then another sixteen patients will be included. A cohort is considered positive if five or more patients of the total twenty-four patients, respond to the treatment.

The protocol for the study has been sent to The Norwegian Medicines Agency and it is expected to start in the beginning of 2021. The patients need to be referred to the study by their general practitioner or hospital clinician.

The study requires a national infrastructure

IMPRESS-Norway requires that cancer patients are offered an in-depth analysis of the cancer tumour’s genetic mutations. Therefore, the academic environments have worked, with dedicated funds from the regional health authorities, to establish a national infrastructure for precision diagnostics for cancer patients (National infrastructure for precision diagnostics called InPred).

Mapping 500 genes

The establishment of these new diagnostic services is already well underway at several hospitals. The goal is to offer expanded molecular diagnostics with mapping of 500 genes to all cancer patients who are eligible for clinical trial inclusion. The molecular results will be discussed in a national molecular tumour board, consisting of clinicians, pathologists and informaticians, and if the analysis shows that the patient has genetic mutations that can be treated with targeted therapy, the patient can be referred to the appropriate clinical trial or to IMPRESS-Norway.

Collaboration with pharmaceutical companies

IMPRESS-Norway is in dialogue with 17 pharmaceutical companies about contributing approved drugs that can be tested outside their approved indication (off-label). One goal with the study is to try out a concrete model for the implementation of personalized medicine. The clinical study will give health personnel and researchers unique experience with precision medicine and the use of molecular diagnostics in treatment, and will offer new treatments to a group of patients who have used up all other options. In addition, the collaboration partners of IMPRESS-Norway are planning to build a public – private collaboration (called CONNECT) where the experiences from IMPRESS-Norway will provide knowledge of how precision medicine affects, among other things, health economy, the health industry and the health services.

Learning from the Netherlands

IMPRESS-Norway is modelled on a precision medicine study called DRUP, which is currently ongoing in the Netherlands. Similar studies are being planned in several European countries and IMPRESS-Norway plans to collaborate on data sharing with the other Nordic countries. This is especially important since we know from experiences with the DRUP study that individual molecular profiles are so rare that it is difficult to fill the cohorts in a single country and therefore it becomes important to compile data from similar cohorts across studies.