706P - The IMPRESS-Norway trial: Improving public cancer care by implementing precision cancer medicine in Norway - Safety analysis of the first 126 patients included in the trial

Background

IMPRESS-Norway is a national, prospective, investigator-initiated, open-label, non-randomized combined basket and umbrella precision medicine trial. Patients with advanced malignancies with no further treatment options are included and treated in multiple treatment cohorts, defined by tumor type, molecular alteration and study drug.

Methods

The trial started recruitment in April 2021, and by February 2023, 126 patients were included in treatment cohorts. Patients were treated with: trametinib (n=28); pertuzumab+trastuzumab (n=25); atezolizumab (n=19); vemurafenib+cobimetinib (n=16); trametinib+dabrafenib (n=12); alpelisib (n=11); pemigatinib (n=6); atezolizumab+ bevacizumab (n=4); vismodegib (n=3); alectinib (n=1) and imatinib (n=1). Per protocol, adverse events (AEs) grade ≥ 3 and serious adverse events (SAEs) are collected, allowing us to perform a preliminary safety analysis of currently treated patients.

Results

In total, 172 AEs and 131 SAEs were reported by February 2023. 32% of all AEs, were considered as not related or unlikely related to treatment, 35% were classified as possibly related and 27% as related to treatment. Conversely, 60% of the SAEs we considered as not related or unlikely related to treatment, 28% as possibly related and 10% as related to treatment. Ten AEs and two SAEs were still not evaluated at the time of data collection. Six deaths were registered during the treatment period, one considered to be treatment related, and four suspected unexpected serious adverse reactions (SUSARs) were reported. Nine patients discontinued treatment permanently due to AE. Detailed analysis and updated results will be presented.

Conclusions

We report preliminary safety analysis of eleven drugs or drug combinations used in the IMPRESS-Norway trial. All drugs are used outside of their current indications. These first results show safety profiles consistent with toxicities reported in earlier trials.

Clinical trial identification

EudraCT 2020-004414-35; NCT04817956.

Editorial acknowledgement

Legal entity responsible for the study

Oslo University Hospital.

Funding

The regional health authorities of Norway, Norwegian Cancer Society, The Norwegian Radium Hospital Legats and Nordforsk is offering financial support. Roche, Novartis, Eli Lilly, AstraZeneca, Incyte and Merck are providing the study drugs and financial support.

Disclosure

K. Puco: Financial Interests, Personal, Advisory Board, Both advisory board and invited speaker: Astellas Pharma, MSD, Bayer Norway, Pfizer AS; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb (BMS), Ipsen, Janssen-Cilaq; Financial Interests, Institutional, Funding: AstraZeneca, Roche, Novartis, Eli Lilly, Incyte, Merck, Illumina. E.S. Blix: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo, Eli Lilly, Gilead, MSD; Financial Interests, Personal, Invited Speaker: Novartis, Pfizer, Pierre Fabre, Roche. A. Flobak: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer, Pierre Fabre, Amgen, Bayer. C. Fredvik Torkildsen: Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca. T.K.K. Guren: Financial Interests, Institutional, Other, Honoraria: Pierre Fabre; Financial Interests, Institutional, Local PI: Genentech/Roche, MSD, Merus, Pfizer, Ultimovacs, Eli Lilly/Loxo, Novartis, Boehringer Ingelheim. H.E.G. Russnes: Financial Interests, Institutional, Invited Speaker, Speaker on Illumina satellite meeting ( ESMO 2022): Illumina; Financial Interests, Institutional, Advisory Board, Novartis satellite meeting, Nordic Lung Cancer meeting, 2022: Novartis; Financial Interests, Institutional, Other, Debate, precision medicine, Oslo 2022 : Merck; Financial Interests, Institutional, Other, Participation, round table, Cholangiocarcinoma; Nordic meeting 2021: Incyte; Financial Interests, Institutional, Coordinating PI, Funding of 500 FMliquid test to patients in the IMPRESS-Norway trial: Roche Norway; Financial Interests, Institutional, Coordinating PI, Funding of TSO500 liquid tests for 500 patients in the IMPRESS-Norway trial: Illumina; Non-Financial Interests, Leadership Role, InPreD is an establishment in the public health care, securing disciplinary work when implementing precision diagnostics for cancer: National Infrastructure for Precision Diagnostics (InPreD); Non-Financial Interests, Leadership Role, A network structure established as part of the public health care system, to share knowledge, build competence and work with harmonisation and standardisation to implement precision medicine: National Competence Network for Precision Medicine; Non-Financial Interests, Leadership Role, Head of working group for molecular pathology and for the Norwegian association for molecular pathology: The Norwegian Association of Pathology. K. Tasken: Financial Interests, Personal, Advisory Board, Company established based on innovation in my lab. Holds stock and Scientific advisor: Serca Pharmaceuticals; Financial Interests, Personal, Stocks/Shares, Stock and Stock options, and royalty agreement through Oslo UniversityHospital / University of Oslo Tech Transfer Office Inven2 AS: Serca Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Ledidi; Financial Interests, Personal, Royalties, Stock and Stock options, and royalty agreement through Oslo UniversityHospital/University of Oslo Tech Transfer Office Inven2 AS: Serca Pharmaceuticals; Financial Interests, Institutional, Steering Committee Member, IMPRESS-Norway trial Trial Management & Steering Committee: Roche; Financial Interests, Institutional, Steering Committee Member, IMPRESS Norway trial Trial Management & Steering Committee: Novartis, Lilly, Incyte, Merck KGaA, AstraZeneca, Illumina. 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, Coordinating PI, BMS provides drug to patients in an investigator initiated clinical trial: BMS; Financial Interests, Institutional, Coordinating PI, Ultimovacs provides drug and funds for investigator initiated clinical trial: Ultimovacs; Financial Interests, Institutional, Coordinating PI, AstraZeneca provides drug and funds for investigator initiated clinical trial: AstraZeneca; Financial Interests, Institutional, Coordinating PI, Roche provides drug and funds for investigator initiated clinical trial: Roche; Financial Interests, Institutional, Coordinating PI, Novartis provides drug and funds for clinical trial: Novartis; Financial Interests, Institutional, Coordinating PI, Eli Lilly provides drug and funds for clinical study: Eli Lilly; Financial Interests, Institutional, Coordinating PI, Incyte provides drug and funds for clinical study: Incyte; Financial Interests, Institutional, Coordinating PI, Illumina provides assays for patients in a clinical trial: Illumina; Non-Financial Interests, Other, Board member in the patient organisation until 2022. Provides advice and gives talks: The lung cancer patients organisation. All other authors have declared no conflicts of interest.