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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

 

New partners join precision medicine consortium

Five new partners have joined CONNECT, a public-private consortium driving the implementation of precision cancer medicine in Norway, coordinated by Oslo Cancer Cluster.

The five latest additions to the public-private consortium CONNECT include the Norwegian Directorate of Health (Helsedirektoratet), the Norwegian Medicines Agency (Statens Legemiddelverk), and pharmaceutical companies Lilly, MSD and Janssen.

The Norwegian Directorate of Health and the Norwegian Medicines Agency are the most recent public partners to join this unique national public-private partnership.

“The Norwegian Medicines Agency is happy to have joined CONNECT as an observer. Personalised medicine is currently high on the agenda, and we look forward to the extended opportunity for dialogue with national and international stakeholders, provided by CONNECT,” said Karen Marie Ulshagen, Strategic Director, Timely Access, Norwegian Medicines Agency.

The ten pharma companies who co-founded CONNECT in December 2020 are now accompanied by Lilly, MSD and Janssen, all sharing the same vision to drive the implementation of precision cancer medicine in Norway.

“CONNECT represents a collective effort between partners in the healthcare industry (private, public and voluntary sectors) and has the potential to build a culture which fosters innovation, collaboration and development of competency with the increased benefit for the individual patient as the core priority,” said Hilde Enserink, interim Medical Director and Oncology Lead, MSD Norway.

“With our focus on precision cancer medicine in our pipeline and our belief that dialogue and co-operation between all stakeholders is the right way forward, CONNECT fits very well with our purpose in Janssen. In the end though, it is the patients that matter the most and we hope CONNECT will eventually lead to a wider and earlier access to new precision cancer medicines for cancer patients in Norway,” said Sverrir Valgardsson, Medical Affairs Lead, Janssen Norway.

Ravinder Singh, Senior Clinical Research Scientist, Nordic Medical Lead, Lilly, complemented: “The implementation of precision medicine in Norway is a very important measure for Norwegian cancer patients, but at the same time very challenging considering the technological, medical, and regulatory aspects. A united front to facilitate precision medicine, where the pharmaceutical industry is seen as a partner rather than a financial contributor, will be of use for the academic milieu, the industry itself and for Norwegian cancer patients.”

Other CONNECT partners are the Norwegian Pharmaceutical Industry Association (Legemiddelindustrien – LMI), the Norwegian Cancer Society (Kreftforeningen), the Norwegian Institute of Public Health (Folkehelseinstituttet) and the tech companies NEC and PubGene. The unique blend of participants enables CONNECT to address current obstacles facing precision cancer medicine in Norway.

Gathering experts to find new solutions

CONNECT was initiated by 22 founding partners in December 2020 and is coordinated by Oslo Cancer Cluster.

Since its establishment, CONNECT has carried out its activities through four working groups gathering experts from the different university hospitals, authorities, industry and the Norwegian Cancer Society. The working groups had regular digital meetings since February 2021, where they created a joint understanding of the challenges and opportunities associated with the introduction of cancer precision medicine in a public healthcare setting and started the first initiatives.

CONNECT has also offered open, educational meetings and some are still available to be viewed via the CONNECT webpage Recordings of past events.

The next public meeting will take place during Arendalsuka and be held in Norwegian. The topic is How to succeed with precision cancer medicine – Research and collaboration that brings us further. The event will include conversations about emerging research and treatment opportunities for cancer patients in Norway.

Collaborating with national clinical study

CONNECT has facilitated dialogue meetings between industry representatives and the national initiatives IMPRESS-Norway and InPreD.

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. Patients who are eligible for the treatments available in IMPRESS are then offered to participate in the clinical study.

The pharmaceutical company Novartis agreed this week to contribute six new medicines to IMPRESS-Norway to treat up to one hundred patients. More information about this will be published in English next week.

 

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.

Landmark public-private agreement for precision cancer medicine

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