Found 1 Presentation For Request "503P"
503P - The IMPRESS-Norway trial: Improving public cancer care by implementing precision cancer medicine in Norway
- Aaslaug Helland (Oslo, Norway)
Abstract
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.
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.