En forsker undersøker celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

Nye kreftbehandlinger krever nye samarbeidsformer

En forsker undersøker et celler fra en kreftsvulst. Illustrasjonsfoto: AstraZeneca

I et debattinnlegg i Aftenposten beskriver Sigbjørn Smeland, Steinar Thoresen og Ketil Widerberg hvordan Norge er i en internasjonal særstilling for godt samarbeid i helsesektoren.

This opinion piece was originally printed in the daily newspaper Aftenposten and is only available in Norwegian. / Debattinnlegget sto først på trykk i Aftenposten mandag 9. august, og kan også leses på aftenposten.no.

 

Innføring av nye legemidler for små pasientgrupper tar unødvendig lang tid. Noen blir ikke tatt i bruk i Norge i det hele tatt. Det er en utfordring.

Direktørene i helseforetakene mener hovedgrunnen er at legemiddelprisene er for høye i forhold til nytten for pasientene. Legemiddelindustrien (LMI) mener at store utviklingskostnader gjør at medisinene er dyre. Pasientorganisasjonene påpeker at byråkrati og prestisje går foran alvorlig syke.

Alle har rett. Likevel er ikke løsningen å argumentere videre i hver sin retning. Det trengs et nytt samarbeid mellom industri, myndigheter og pasientorganisasjoner.

Et nasjonalt samarbeid

Hoveddelen av nye legemidler innføres innen kreft. Her er det nylig etablert et nasjonalt samarbeid som heter Connect. Det skal nettopp forbinde alle oss som jobber med kreft, som legemiddelfirmaer, regulerende myndigheter, Kreftforeningen og sykehusleger.

Målet er å finne løsninger for å få tilgjengelig ny medisin til små pasientgrupper. Det kalles presisjonsmedisin. Connect omfatter både avansert diagnostikk og nye behandlingsmetoder. Det har som ambisjon å løfte frem nye prinsipper for finansiering av nye legemidler.

Innføring av presisjonsmedisin er på mange måter et puslespill. Vårt mål er å sette brikkene sammen til et helhetlig bilde som både er bra for pasientene, men som også skaper innovasjon og er innenfor rammene og prioriteringene vi har i Helse-Norge.

Presisjonsmedisin for små pasientgrupper innebærer at utviklingskostnadene deles på færre pasienter. Dette driver kostnadene oppover.

Dagens gullstandard ved innføring av nye medikamenter er randomiserte kliniske studier. Randomisering innebærer at behandlingene vi sammenligner i en studie, blir tildelt deltagerne helt tilfeldig. Det krever store pasientgrupper og er derfor ikke egnet som eneste grunnlag ved innføring av presisjonsmedisin.

Det illustrerer også en fordel med presisjonsmedisin: Kun et utvalg av pasientene vil bli tilbudt behandlingen, basert på analyser av kreftsvulsten. Det hindrer overbehandling, som vi ser i utstrakt grad i dag.

Lære fra hver pasient

Det er derfor nødvendig med felles utvikling av nye løsninger. Det betyr ikke at firmaer får automatisk godkjenning, eller at klinikere får alt de ønsker til pasientene. Regulerende myndigheter får nok heller ikke jobbe på den samme trygge måten som før. Dette blir et krevende samarbeid for alle parter.

Innføring av presisjonsmedisin i helsevesenet er en utfordring de fleste land sliter med. Samtidig er det en enorm mulighet for kostnadsbesparelser og forbedret omsorg. Et stikkord er «midlertidig godkjenning» under forutsetning av fortsatt kunnskapsgenerering.

For vi må lære fra hver eneste pasient. I Norge gjør vi fremskritt, for eksempel gjennom samarbeid om helsedata, tidlig innføring og ny nasjonal handlingsplan for kliniske studier. Myndigheter og industri finner i økende grad løsninger sammen.

Norge i en særstilling

I Norge kan vi etter samtykke samle informasjon fra blodprøver og overskuddsvev. Dette kan kobles opp mot helseopplysninger fra våre unike kvalitetsregistre. Ett eksempel er Kreftregisteret.

Her er vi internasjonalt i en særstilling. Det kan gi oss interesse fra legemiddelfirmaer og bidra til at flere kliniske studier kommer til Norge.

Men det vil kreve en satsing fra våre politikere. I dag mangler infrastruktur i storskala, og da spesielt drift av biobanker. Dette må på plass. Først da kan vi hevde at vi oppfyller målsetningen om at vi skal lære av hver eneste pasient.

Samarbeid mellom offentlig og privat sektor kan gjøre Norge mer interessant for klinisk utprøvning. Det kan igjen gjøre flere legemidler tidlig tilgjengelig for norske pasienter.

Alene redder det ikke liv. Alene skaper det heller ikke en ledende helsenæring i Norge. Men det hjelper betydelig på veien.

 

Artikkelforfattere:

Sigbjørn Smeland, Klinikkleder ved Oslo universitetssykehus, styreleder i Connect

Steinar Thoresen, Leder av Oncology I Norden og Baltikum i Merck, styremedlem i Connect

Ketil Widerberg, Leder av Oslo Cancer Cluster, styremedlem i Connect

Novartis is happy to join IMPRESS-Norway. Tarje Bergdahl, Nordic Medical Director Oncology, and Gry Lønne Eriksson, Medical Advisor Hematology and Oncology, have both been involved in the process of joining the largest cancer study in Norway. Photo: Novartis

Novartis enters IMPRESS

Smiling and looking into the camera is Lars-Petter Strand, Head of Medical & Country Manager Norway og Gry Lønne Eriksson, Medical Advisor Hematology and Oncology, Novartis.Novartis

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

 

The five new partners that have joined CONNECT in the last six months are the Norwegian Health Directorate, the Norwegian Medicines Agency, Janssen, Lilly and MSD.

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.

 

Cancer Crosslinks 2020 gathered a distinguished group of national and international speakers, and received a record number of meeting delegates.

Cancer Crosslinks 2020

The speakers, chairpersons, introducers and organizers of Cancer Crosslinks 2020Oslo Cancer Cluster

Engaging presentations by leading international and Norwegian oncology experts at the 12th Cancer Crosslinks “Progress in Cancer Care – A tsunami of promises or Game Changing Strategies?”.

Oslo Cancer Cluster’s annual meeting gathered more than 350 delegates from all over Norway at the Oslo Cancer Cluster Innovation Park, and more than 50 participants followed the live stream. The record high participation shows the large interest in translational cancer research and the importance of the programme for the Norwegian oncology community.

Cancer Crosslinks has become one of the largest national meeting places for oncologists, haematologists, translational researchers, regulatory experts and industry representatives. The meeting offers a full day educational program.

The aim of the conference is to stimulate broader interactions between researchers and clinicians, to encourage translational and clinical research, and to inspire collaborations. Novel partnerships between industry, academia and authorities are essential to deliver new treatments and diagnostics to Norwegian cancer patients.

“At the start of 2020, cancer patients have more treatment options than ever before. Immuno-oncology is firmly established as the fourth pillar of cancer treatment and the tremendous progress in the field is reflected in increased survival rates,” said Jutta Heix, Head of International Affairs, Oslo Cancer Cluster. “However, many patients do not benefit from novel treatments and we still have significant gaps in our understanding of the complex biological mechanisms. Deciphering this complexity is a task for the decade to come. The Cancer Crosslinks 2020 speakers are shedding light on emerging concepts and key challenges and discuss how they are addressing them to advance cancer care.”

The audience at Cancer Crosslinks 2020.

The audience at Cancer Crosslinks 2020. Photo: Cameo Productions UB/Oslo Cancer Cluster

An inspiring programme

Referring to a record number of new oncology drug approvals in recent years and an enormous global pipeline of drugs in late-stage development, this year’s programme addressed the question “Progress in Cancer Care – A Tsunami of Promises or Game-Changing Strategies?”. Distinguished international experts from leading centres in the US and Europe presented emerging concepts, recent progress and key questions to be addressed for both solid and haematological cancers.

Cancer researchers and clinicians from all of Norway enjoyed excellent presentations and engaging discussions with speakers and colleagues.

“Cancer Crosslinks 2020 gave me an opportunity to listen to talks by international top scientists, and discuss some of the latest developments in translational cancer research with meeting participants from academia and industry in a relaxed and inspiring setting,” said Johanna Olweus, Head of Department of Cancer Immunology at the Institute for Cancer Research.

“Cancer Crosslinks is always a meeting that makes me proud of being part of Oslo Cancer Cluster. It is inspiring to see Norwegian and international participants come together to discuss recent progress in cancer research and how to develop cancer treatments for the patients,” said Øyvind Kongstun Arnesen, Chairman of the Board, Oslo Cancer Cluster.

The day programme was complemented with an evening reception in the city center where speakers and delegates continued their lively discussions and listened to an inspiring talk by Ole Petter Ottersen, President of Karolinska Institute, at Hotel Continental in Oslo.

Cancer Crosslinks was established by Oslo Cancer Cluster in 2009 in collaboration with the pharmaceutical company Bristol-Myers Squibb.

“Cancer Crosslinks 2020 has been a fantastic conference, where the presenters have given an excellent description of current and near future achievements within cancer research and the importance of understanding the underlying biology of cancer to rationally give patients the correct cancer therapy. In particular within immunotherapy, there is a need to understand the dynamic complexity of tumor immunology and how to apply the best and tailored immuno-oncology based treatment strategy for cancer patients,” said Ali Areffard, Disease Area Specialist Immuno-Oncology, Bristol-Myers Squibb.

This year, the pharmaceutical company Sanofi Genzyme Norway was a proud co-sponsor of the meeting.

“It was great to be able to provide a platform for interaction between the Norwegian scientific cancer environment and top international research capacities. Therefore, it was with huge enthusiasm Sanofi Genzyme co-sponsored this important conference. New treatment options in oncology are developing fast, where new treatment modalities provide clinicians with additional and superior options. New treatments specifically targeting the malignant cells, as well as activating the host immune response towards the cancer, provides tools to significantly improve current cancer treatments. This year’s Cancer Crosslinks conference gave an excellent insight into this,” said Knut Steffensen, Medical Advisor Hematology Nordic & Baltics, Sanofi Genzyme.

Interview with Prof. Jason Luke

View the interview with Prof. Jason Luke, by HealthTalk, in the video below:

Interview with Prof. Michel Sadelain

View the interview with Prof. Michel Sadelain, by HealthTalk, in the video below:

The speakers at Cancer Crosslinks 2020

Jason J. Luke, Director of the Cancer Immunotherapeutics Center, Associate Professor of Medicine, University of Pittsburgh Medical Center and Hillman Cancer Center

Jason J. Luke, MD, FACP, Director of the Cancer Immunotherapeutics Center, Associate Professor of Medicine, University of Pittsburgh Medical Center and Hillman Cancer Center, USA. Photo: Cameo UB Productions/Oslo Cancer Cluster

Stefani Spranger, Howard S. and Linda B. Stern Career Development Assistant Professor, Koch Institute for Integrative Cancer Research at MIT, Cambridge

Stefani Spranger, Howard S. and Linda B. Stern Career Development Assistant Professor, Koch Institute for Integrative Cancer Research at MIT, Cambridge, USA. Photo: Cameo UB Productions/Oslo Cancer Cluster

Harriet Wikman, Professor, Group Leader, Center for Experimental Medicine, Institute of Tumor Biology, University Medical Centre Hamburg-Eppendorf

Harriet Wikman, Professor, Group Leader, Center for Experimental Medicine, Institute of Tumor Biology, University Medical Centre Hamburg-Eppendorf, Germany. Photo: Cameo UB Productions/Oslo Cancer Cluster

Vessela Kristensen, Professor, Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital

Vessela Kristensen, Head of Research and Development and Director of Research at the Dept. of Medical Genetics, Oslo University Hospital, Norway. Photo: Cameo UB Productions/Oslo Cancer Cluster

Peter A. Fasching, Professor of Translational Gynecology and Obstetrics, University Hospital and Comprehensive Cancer Center Erlangen-EMN

Peter A. Fasching, Professor of Translational Gynecology and Obstetrics, University Hospital and Comprehensive Cancer Center Erlangen-EMN, Germany. Photo: Cameo UB Productions/Oslo Cancer Cluster

Karl Johan Malmberg, Professor, Group Leader Dept. of Cancer Immunology and Director STRAT-CELL, Oslo University Hospital, Norway.

Karl Johan Malmberg, Professor, Group Leader Dept. of Cancer Immunology and Director STRAT-CELL, Oslo University Hospital, Norway. Photo: Cameo UB Productions/Oslo Cancer Cluster

Michel Sadelain, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center

Michel Sadelain, MD, PhD, Professor, Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, USA. Photo: Cameo UB Productions/Oslo Cancer Cluster

Bjørn Tore Gjertsen, Consultant Hematology, Haukeland University Hospital, Norway.

Bjørn Tore Gjertsen, Professor of Hematology, Centre for Cancer Biomarkers CCBIO, Dept. of Clinical Science, University of Bergen, Norway. Photo: Cameo UB Productions/Oslo Cancer Cluster

Hermann Einsele, Professor, Chair, Dept. of Internal Medicine II, Head of the Clinical and Translational Research Program on Multiple Myeloma, Wuerzburg University Hospital

Hermann Einsele, Professor, Chair, Dept. of Internal Medicine II, Head of the Clinical and Translational Research Program on Multiple Myeloma, University Hospital Wuerzburg, Germany. Photo: Cameo UB Productions/Oslo Cancer Cluster

 

Sign up to our monthly newsletter