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Poster session 13

503P - The IMPRESS-Norway trial: Improving public cancer care by implementing precision cancer medicine in Norway

Date

10 Sep 2022

Session

Poster session 13

Topics

Clinical Research;  Therapy

Tumour Site

Presenters

Aaslaug Helland

Citation

Annals of Oncology (2022) 33 (suppl_7): S227-S232. 10.1016/annonc/annonc1052

Authors

A. Helland1, K. Tasken2, H.E..G. Russnes3, L. Fagereng4, E.S. Blix5, S. Brabrand6, T. Donnem7, Å. Flobak8, B.T. Gjertsen9, A. Haug10, R. Hovland11, G. Inpred12, P.E. Lonning13, P. Niehusmann14, K. Puco15, E.S. Samdal10, S. Smeland16

Author affiliations

  • 1 Oncology Dept., Oslo University Hospital, 310 - Oslo/NO
  • 2 Dept. Of Cancer Immunology, Institute For Cancer Research, Oslo University Hospital - The Norwegian Radium Hospital, 0424 - Oslo/NO
  • 3 Pathology, Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo/NO
  • 4 Institute For Cancer Research, Oslo University Hospital - Radiumhospitalet, 0424 - Oslo/NO
  • 5 Dept Of Oncology, University Hospital of North Norway, 9038 - Tromso/NO
  • 6 Division Of Cancer Medicine, University of Oslo, Institute of Clinical medicine, 0379 - Oslo/NO
  • 7 Oncology, University Hospital of North Norway, 9019 - Tromso/NO
  • 8 Oncology, St. Olavs Hospital HF, 7006 - Trondheim/NO
  • 9 Hematology, Haukeland University Hospital, Bergen/NO
  • 10 Oncology Dept., Haukeland Universitetssykehus, 5021 - Bergen/NO
  • 11 Pathology, Haukeland University Hospital, Bergen/NO
  • 12 Cancer Medivine, Oslo University Hospital, Oslo/NO
  • 13 Oncology Department, University of Bergen, 5020 - Bergen/NO
  • 14 Div Of Cancer Medicine, Oslo University Hospital, Oslo/NO
  • 15 Oncology Dept, Lovisenberg Diakonale Sykehus AS, 0456 - Oslo/NO
  • 16 Cancer Medicine, Oslo University Hospital - The Norwegian Radium Hospital, N-0424 - Oslo/NO

Resources

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Abstract 503P

Background

There is a high demand for precision cancer treatment. Methods for advanced molecular diagnostics are available, and a considerable number of drugs are already approved on specific indications. However, these drugs are only to be used within subgroups of patients with the specific diagnostics determined by clinical studies. Some drugs targeting a specific pathway or gene aberration, might just as well be efficient in patients with other tumour types, not yet tested.

Methods

In this national, investigator-initiated, prospective, open-label, non-randomized combined basket- and umbrella-trial, patients are enrolled into multiple parallel treatment cohorts. Patients with progressive disease with no further standard therapy, are eligible. Each cohort is defined by the patient’s tumour type, molecular profile of the tumour, and study drug. Treatment outcome in each cohort is monitored by using a Simon two-stage-like ‘admissible’ monitoring plan to identify evidence of clinical activity. All drugs available in IMPRESS-Norway are regulatory approved. Molecular diagnostics with the TSO-500 gene panel are funded by the public health care system. In addition, patients included in IMPRESS-Norway are screened by analyses of ctDNA. Currently, 17 drugs are provided by five different pharmaceutical companies / research grants. The primary objective in the study is clinical benefit of treatment at 16 weeks of treatment, defined as complete response, partial response, or stable disease.

Results

The trial opened for accrual April 1st 2021. As of April 25, 2022, 359 patients had been included in the molecular screening, and 295 had completed evaluation in the national molecular tumour board. 67 patients were allocated to therapy in an IMPRESS-Norway treatment-cohort. Early aggregated data at 16-weeks show clinical benefit in 43% (12/26 of the first patients reaching 16 weeks of treatment). Updated results will be presented.

Conclusions

Patients with advanced cancer progressing on standard treatment are eligible for IMPRESS-Norway. Genetic alterations indicating benefit of the drugs currently available in the study, are detected in 23% of the patients.

Clinical trial identification

EudraCT: 2020-004414-35; NCT04817956.

Editorial acknowledgement

Legal entity responsible for the study

Oslo University Hospital.

Funding

Funding from the regional health authorities, The Norwegian Cancer Society, Radiumhospitalets legater, Drug and funds from Roche, Novartis, Incyte, Eli Lilly and AstraZeneca.

Disclosure

A. Helland: Financial Interests, Institutional, Advisory Board, Advisory boards: Jansen, Takeda, AstraZeneca, AbbVie, Roche, BMS, Pfizer, MSD, Bayer, Lilly,; Financial Interests, Institutional, Invited Speaker, talks at meetings: AstraZeneca, Roche, AbbVie, Pfizer; Financial Interests, Institutional, Invited Speaker, BMS provides drug to patients in an investigator initiated clinical trial: BMS; Financial Interests, Institutional, Invited Speaker, Ultimovacs provides drug and funds for investigator initiated clinical trial: Ultimovacs; Financial Interests, Institutional, Invited Speaker, AstraZeneca provides drug and funds for investigator initiated clinical trial: AstraZeneca; Financial Interests, Institutional, Invited Speaker, Roche provides drug and funds for investigator initiated clinical trial: Roche; Financial Interests, Institutional, Invited Speaker, Novartis provides drug and funds for clinical trial: Novartis; Financial Interests, Institutional, Invited Speaker, Eli Lilly provides drug and funds for clinical study: Eli Lilly; Financial Interests, Institutional, Invited Speaker, Incyte provides drug and funds for clinical study: Incyte; Non-Financial Interests, Other, Board member in the patient organisation. Provides advice and gives talks: The lung cancer patients organisation. All other authors have declared no conflicts of interest.

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