Posts

First pharma company joins IMPRESS-Norway

/in , /by

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.

Landmark public-private agreement for precision cancer medicine

/in , /by

Scroll down to read the press release in Norwegian.

While more than 30 000 Norwegians are diagnosed with cancer every year and the incidence is still increasing, more precise treatments can save lives. CONNECT is a new initiative aiming to ensure that precision medicine reaches the patients.

“A serious cancer disease is an existential challenge for the individual. Cancer research gives hope. The pharmaceutical industry and the public health sector, clinicians and executive authorities, have to collaborate to offer new treatments, balancing the latest research with hospital operations,” says Åsmund Flobak, Oncologist at St Olav’s Hospital, Trondheim University Hospital.

The new initiative, called CONNECT (Norwegian Precision Cancer Medicine Implementation Consortium), is a direct response to Health Minister Bent Høie’s political guidance to accelerate the implementation of precision medicine for Norwegian patients. It also responds to the Health Minister’s ambition to increase research and collaboration between public and private actors, including hospitals, other public stakeholders, the Norwegian Cancer Society, and the pharmaceutical industry.

CONNECT is one of four interconnected initiatives that will ensure infrastructure and collaboration on diagnostics, clinical trials, implementation of advanced precision medicine and use of health data e.g. for health economics analysis. This could eventually affect how Nye Metoder (The National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway) is adapted for personalized medicine and treatments for small patient groups in cancer.

See the fact boxes about the different initiatives at the bottom of this page.

Precision medicine for the future

Precision medicine, or personalised medicine, is a type of treatment tailored to the individual patient based on individual diagnostic and clinical information. In simple words, it is about giving the right treatment to the right patient at the right time.

“The research front is continuously moving forward. With modern technology, today’s clinicians can analyse specific changes in the cancer of each patient. There are individual changes in a patient’s tumour that can be treated with targeted therapies tailored to every individual patient,” says Bjørn Tore Gjertsen, Director of Research at Haukeland University Hospital, Helse Bergen Health Trust.

“Precision medicine changes healthcare. The implementation of precision medicine requires new types of interactions and partnerships among patients, clinicians, companies, regulators, and payors. CONNECT is a new public-private partnership allowing all stakeholders to jointly address key obstacles and piloting novel solutions,“ says Jutta Heix, Project Manager for CONNECT and Head of International Affairs at Oslo Cancer Cluster.

A nationwide effort towards a common goal

CONNECT is a unique national partnership where the central players join forces to accelerate the implementation of precision medicine.

All six university hospitals in Norway are partners in CONNECT. More than ten leading pharmaceutical companies have joined the initiative so far. As representative for patients, the Norwegian Cancer Society will play a central role.

“We are also having a good dialogue with the Norwegian Directorate of Health, the Norwegian Institute of Public Health and the Norwegian Medicines Agency about participating in CONNECT and contributing with their competency. The Institute of Public Health joins as an observer from the start and the Directorate of Health has expressed an intention to join as an observer as well,” says Kjetil Tasken, Head and Director of the Institute for Cancer Research at Oslo University Hospital.

Karen Marie Ulshagen, Area Director at the Norwegian Medicines Agency, says in a comment that the Medicines Agency supports the project and intends to engage.

“A culture for public-private collaboration is not created through strategic plans, political ambitions or celebratory speeches, but through actions and behaviours that set a new standard. CONNECT is not about money or donating pharmaceuticals. It is the combined expertise of the different players and agencies that will increase the competency essential to ensure the implementation of precision medicine. Novartis is happy to participate, and I think that is true for the other industry players too,” says Lars Petter Strand, Head of Medical, Novartis Oncology Norway. He has worked closely together with representatives from Roche, BMS and Merck in the working group for CONNECT.

CONNECT and the associated public initiatives work towards common goals: giving patients access to medicines they otherwise wouldn’t receive, increasing the precision medicine experience of clinicians and researchers nationwide, generating data and insights important for analysing the outcomes and adopting health technology assessments for these new treatment concepts. Via CONNECT a structured dialogue, information sharing and planning for national precision medicine and diagnostics will be established, with Oslo Cancer Cluster having the coordinating role.

Unique public-private partnership

CONNECT will be an arena for all partners and stakeholders to address important issues and will ensure a balanced, broad, and informed approach and debate.

“This is a concrete and important milestone for public-private collaborations in the health sector and builds on the ambitions from, among other things, HelseOmsorg21. This is a completely new way to work in Norway and I hope it paves the way for more collaborative projects and pilots between private and public players in healthcare,” says Karita Bekkemellem, CEO of Legemiddelindustrien (LMI).

 

Press release in Norwegian:

Inngåelse av historisk offentlig-privat kreftsamarbeid

Mer enn 30 000 nordmenn diagnostiseres med kreft hvert år og antall krefttilfeller øker, mer presis behandling vil kunne redde liv. CONNECT er et nytt initiativ med mål å sørge for at presisjonsmedisin når pasientene.

– Alvorlig kreftsykdom er en eksistensiell utfordring for den enkelte. Kreftforskning er håp. Privat legemiddelindustri og offentlig helsevesen, både behandlere og overordnet byråkrati, må samarbeide for å kunne tilby ny behandling i grenseflaten mellom forskningsfront og sykehusdrift, sier Åsmund Flobak, lege ved Kreftklinikken St Olavs hospital.

Det nye initiativet, som kalles CONNECT, er en direkte respons til helseminister Bent Høies ønske om å akselerere implementering av presisjonsmedisin for norske pasienter. Det svarer også helseministerens ønske om mer forskning, og aktivt samarbeid mellom offentlige og private aktører som blant annet sykehus, andre offentlige interessehavere, Kreftforeningen og legemiddelindustrien.

Avtalen er en del av flere initiativ som vil sikre en infrastruktur og samarbeid for diagnostikk, kliniske studier, implementering av avansert presisjonsmedisin og bruk av helsedata til blant annet helseøkonomiske analyser. Dette vil etter hvert kunne påvirke hvordan systemet for Nye Metoder tilpasses persontilpasset medisin og behandlinger til små pasientgrupper innen kreftområdet.

Se faktaboks om de ulike initiativene nederst i saken.

Presisjonsmedisin for fremtiden

Presisjonsmedisin, eller persontilpasset behandling, er en form for kreftbehandling som er tilpasset spesielt den enkelte pasient. Kort fortalt handler dette om å gi riktig medisin til riktig pasient og til riktig tid.

– Forskningsfronten flytter seg stadig fremover, og med moderne teknologi kan leger i dag undersøke detaljerte forandringer i kreftsvulster hos hver enkelt pasient. Det finnes individuelle forandringer i arvestoffet som kan behandles med målrettede behandlinger som er tilpasset hvert enkelt individs behov sier Bjørn Tore Gjertsen, forskningssjef, Helse Bergen

– Presisjonsmedisin forandrer hele helsetjenesten og krever nye typer samarbeid og partnerskap mellom pasienter, klinikere, selskaper, regulatoriske myndigheter og betalere. CONNECT er et helt nytt offentlig-privat samarbeid som vil gi alle parter felles muligheter for å adressere utfordringer og prøve nye løsninger, sier Jutta Heix, prosjektleder for CONNECT og leder for internasjonal kontakt i Oslo Cancer Cluster.

Samler hele Norge for felles mål

CONNECT er et unikt partnerskap der alle de sentrale aktørene er samlet for å akselerere innføringen av presisjonsmedisin.

Alle seks universitetssykehus i Norge er med som partnere. Over ti ledende legemiddelselskaper har også gått med i initiativet. Som representant for pasientperspektivet er Kreftforeningen sentral.

– Vi har også hatt en god dialog med Helsedirektoratet, Folkehelseinstituttet og Legemiddelverket om å delta i CONNECT og bidra med sin kompetanse. Folkehelseinstituttet kommer inn som observatør fra starten, Helsedirektoratet har uttrykt en intensjon om å være med som observatør i CONNECT, sier Kjetil Tasken, leder for Institutt for Kreftforskning ved Oslo Universitetssykehus.

Karen Marie Ulshagen, Områdedirektør, SLV sier i en kommentar at Legemiddelverket støtter prosjektet og har en intensjon om en nærmere tilknytning dersom det er mulig.

– Kultur for offentlig-privat samhandling skapes ikke ved strategiske planer, politiske ambisjoner eller festtaler, kun gjennom handling og adferd som setter en ny standard. CONNECT handler ikke om penger eller donasjon av legemidler, det er den faglige ekspertisen fra de ulike aktører og instanser som utgjør kompetanseløftet som er essensielt for å sikre innføring av presisjonsmedisin. Novartis er glad for å kunne ta del i dette, og det tror jeg gjelder de andre industriaktørene også, sier Lars Petter Strand, Medisinsk Direktør i Novartis. Han har arbeidet tett sammen med representantene fra firmaene Roche, BMS, Merck i arbeidsgruppen for CONNECT.

Målet er at CONNECT og de underliggende initiativene sammen kan bidra til å gi pasienter tilgang til medisiner som de ikke ellers ville fått, helsepersonell og forskere får unik erfaring med denne type medisiner og diagnostikk, og helsevesenet vil få data og erfaring fra hvordan presisjonsmedisin fungerer og påvirker måten vi i dag regner helseøkonomi. Gjennom CONNECT skal det etableres strukturert dialog, kunnskapsutveksling og planlegging for persontilpasset medisin og diagnostikk hvor Oslo Cancer Cluster vil ha den koordinerende rollen.

Unikt offentlig-privat samarbeid

Alle medlemmer og interessenter vil kunne ta opp saker som er viktige for dem, da målet er at CONNECT blir en arena som sikrer en bred, balansert og informert debatt.

Dette er et konkret og viktig løft for offentlig-privat samarbeid på helsefeltet og bygger videre på ambisjonene fra blant annet HelseOmsorg21-rådet. Det er en helt ny måte å jobbe på i Norge og jeg håper det baner vei for flere samarbeidsprosjekter og piloter mellom private og offentlige helseaktører, sier Karita Bekkemellem, Administrerende direktør i Legemiddelindustrien (LMI).

 

Fact boxes:

InPreD (Infrastructure for Precision Diagnostics) is a national infrastructure for advanced molecular diagnostics that will secure a robust, interactive structure facilitating clinical cancer trials on a national level by providing equal access for patients to advanced diagnostics, state-of-the art competence and technology.
IMPRESS-Norway (Improving public cancer care by implementing Precision medicine in Norway) is a prospective, non-randomized clinical trial evaluating efficacy of commercially available, anti-cancer drugs prescribed for patients with advanced cancer diagnosed with potentially actionable alterations as revealed by standardized molecular diagnostics. IMPRESS-Norway is a nation-wide study and all hospitals with an oncology and / or hematology department will be invited to participate in the study. As of December 2020, 17 Norwegian Hospitals have agreed to join IMPRESs. The study will use a combined umbrella and basket design and a Simon two-stage model of expanding cohorts to follow up potentially effective combinations of biomarker and drug on specific indications. Sampling of biological material will be performed at presentation, during treatment and upon progression. Additional biomarker and translational analyses including whole genome sequencing (WGS) on tumour material and liquid biopsies, identifying mechanisms underlying drug sensitivity versus resistance will be performed.
INSIGHT (Regulatory framework for implementing precision medicine into the Norwegian health care system) will develop an analytic framework for using synthetic control data for evaluating effects of small-scale one-armed clinical trials, as in IMPRESS-Norway. INSIGHT will use the developed control arms and data from IMPRESS-Norway and InPreD to evaluate cost-effectiveness of the PCM-model and suggest new reimbursement scheme that reflects the uncertainty in PCM. Concrete ethical and legal challenges when integrating clinical research as part of standard-of-care e.g. the need for informed consent, access and data sharing, storage of molecular data as part of diagnostic pipeline will also be addressed. Taken together, the project will deliver fundamental knowledge and suggest regulatory changes/models necessary for implementation of PCM.

 

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

 

 

IMPRESS leads the way for cancer precision medicine

/in , /by

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.