Abstract 5587
Background
While increasing number of diagnostic laboratories perform new generation sequencing on tumor DNA at a rapidly decreasing cost, beyond companion diagnostics, multi-gene panels are still underutilized due to lack of reimbursement and value based technical assessment. Besides financial reasons, prioritizing between diagnostic tests, multiple genetic alterations and multiple on-label or off-label targeted treatment options linked to these alterations can be a major challenge without having a reproducible, standardized and effective information service system in hand that a molecular tumor board could safely rely on. Here, we present an easily clinically adaptable, dynamic treatment decision support program (Protocol), that makes tumor molecular profile-based oncology care feasible and potentially reimbursed by public insurance funds.
Methods
Our Protocol was developed based on 4868 cancer cases with 429 different histology, 2367 genes with 36492 variants. Our program utilizes multidisciplinary molecular tumor board (MTB) supported by Realtime Oncology Treatment CalculatorTM (Calculator) with the idea of integrating molecular and clinical data to provide genomics-driven treatment strategy plan. MTB mobilizes multiple sub-specialties for managing patients and tumor samples. The Calculator under constant upgrade is currently operating based on 24000 rules, 4000+ curated evidence, 101 registered and 618 targeted drugs under development.
Results
This medical procedure (protocol) was endorsed by the Hungarian National Health Insurance Fund based on QUALY gain calculation and value-based technology assessment.
Conclusions
It is crucial to have an established protocol in the community of practice to indicate effective and eliminate ineffective genomics-driven treatments based on molecular profiling. The technology assessment provided evidence that standardized decision support of the molecular tumor board (MTB) to select diagnostic tests and treatments can assure clinical utility and cost effectiveness of multigene testing (NGS).
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
I. Petak: Leadership role, ownership: Oncompass Medicine Hungary Ltd. C. Hegedus: Full / Part-time employment: Oncompass Medicine Hungary Ltd. E. Várkondi: Full / Part-time employment: Oncompass Medicine Hungary Ltd. Z. Farkas: Full / Part-time employment: Oncompass Medicine Hungary Ltd. D. Tihanyi: Full / Part-time employment: Oncompass Medicine Hungary Ltd. R. Dóczi: Full / Part-time employment: Oncompass Medicine Hungary Ltd. D. Mathiasz: Full / Part-time employment: Oncompass Medicine Hungary Ltd. G. Pajkos: Full / Part-time employment: Oncompass Medicine Hungary Ltd. R. Schwab: Advisory / Consultancy, ownership: Oncompass Medicine Hungary Ltd. J. Deri: Full / Part-time employment: Oncompass Medicine Hungary Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
3469 - Ancillary evaluation of systemic immune antitumor response (SIAR) and tumor growth rate (TGR) of patients (pts) with metastatic melanoma (MM) treated with radiotherapy (RT) combined with ipilimumab (ipi) in the phase 1 study Mel-Ipi-Rx.
Presenter: Celine Boutros
Session: Poster Display session 3
Resources:
Abstract
3252 - Genes involved in DNA replication, chromatin remodeling and cell cycle as potential biomarkers for therapy outcome to immune therapy in patients with metastatic cutaneous malignant melanoma
Presenter: Fernanda Costa Svedman
Session: Poster Display session 3
Resources:
Abstract
5545 - Phase Ib/II Study (SENSITIZE) assessing safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical outcome of domatinostat in combination with pembrolizumab in patients with advanced melanoma refractory/non-responding to prior checkpoint inhibitor therapy
Presenter: Jessica Hassel
Session: Poster Display session 3
Resources:
Abstract
5213 - Genomic landscape of primary malignant melanoma of esophagus
Presenter: Jie Dai
Session: Poster Display session 3
Resources:
Abstract
2716 - A phase III, randomised, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation in patients with high-risk cutaneous squamous cell carcinoma (CSCC)
Presenter: Danny Rischin
Session: Poster Display session 3
Resources:
Abstract
3550 - ILLUMINATE 301: A randomized phase 3 study of tilsotolimod in combination with ipilimumab compared with ipilimumab alone in patients with advanced melanoma following progression on or after anti-PD-1 therapy
Presenter: Marcus Butler
Session: Poster Display session 3
Resources:
Abstract
1645 - PRIME002 - Early phase II study of Azacitidine and Carboplatin priming for Avelumab in patients with advanced melanoma who are resistant to immunotherapy
Presenter: Andre Van Der Westhuizen
Session: Poster Display session 3
Resources:
Abstract
4440 - Pembrolizumab (pembro) Plus Lenvatinib (len) for First-Line Treatment of patients (pts) With Advanced Melanoma: Phase 3 LEAP-003 Study
Presenter: Alexander Eggermont
Session: Poster Display session 3
Resources:
Abstract
3454 - Proof of concept study with the histone deacetylase inhibitor vorinostat in patients with resistant BRAFV600 mutated advanced melanoma
Presenter: Sanne Huijberts
Session: Poster Display session 3
Resources:
Abstract
1832 - A phase Ia/Ib clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary anti-tumor activity of FCN-159 in patients with advanced melanoma harboring NRAS-aberrant (Ia) and NRAS-mutation (Ib).
Presenter: Lu Si
Session: Poster Display session 3
Resources:
Abstract