October 2022 • PharmaTimes Magazine • 6
// TREATMENTS //
Nordic Bioscience has announced that the New England Journal of Medicine Evidence (NEJME) has published research that further establishes its extracellular matrix biomarker, PRO-C6, as a potential next-generation biomarker.
It concerns patients with heart failure and preserved ejection fraction (HFpEF). The studies – conducted in collaboration with Bristol Myers Squibb and the University of Pennsylvania – combined analyses of six independent cohorts of HFpEF patients from around the world which are being evaluated with the PRO-C6 biomarker.
HFpEF is a highly heterogenous syndrome greatly affected and driven by underlying comorbidities. With no current treatments that selectively reduce morbidity and mortality, it poses one of the greatest unmet medical needs today, and its prevalence is projected to increase in the coming years.
The PRO-C6 biomarker assay has been transferred to the Roche Diagnostics ‘cobas e’ platform, increasing accuracy in sample measurements and enabling future IVD-based decision-making. It is a further step in making sure that clinical samples are utilised in the best way possible, while also enabling patient segregation and drug decision-making in clinical trials.
Fibrosis is acknowledged to be a key driver of HFpEF pathology, contributing to ventricular stiffness and reduced function. Improving understanding of how fibrosis and extracellular matrix turnover are regulated could be key to unlocking novel treatments for patients.
Novartis has announced new data from the phase 3 RATIONALE 301 trial that shows how tislelizumab demonstrated non-inferior overall survival (OS) compared to sorafenib in patients with previously untreated, unresectable hepatocellular carcinoma (HCC).
RATIONALE 301 is a multi-regional, open-label, randomised phase 3 study of tislelizumab versus sorafenib in previously untreated patients with unresectable HCC. During the trial, 674 participants received either tislelizumab or sorafenib. The primary objective has been to compare OS between the two treatment groups.
The trial met its primary objective of non-inferiority for OS, while superiority was subsequently tested, which was not met. This data was presented at a late-breaking oral session at the 2022 European Society for Medical Oncology Congress.
OS results were consistent across pre-specified subgroups, including regions. Tislelizumab was associated with higher objective response rate and more durable responses than sorafenib. The safety profiles of both agents were consistent with previous reports and no new safety signals were identified.
The European canSERV project – which aspires to defragment the landscape of European cancer research – has begun.
Over the next three years, canSERV will enable academia and industry access to services and support from basic science up to clinical translation. The initiative aims to foster personalised medicine for cancer patients.
All services of the participating infrastructures will be linked on a common platform which will go online within the next few months. canSERV will connect, coordinate and align existing oncology and complementary research infrastructures alongside providing services. This will capitalise on the critical mass of experts and their extended networks.
canSERV aims to accelerate the process of translating theoretical knowledge into personalised oncology clinical practice, which will give cancer patients faster and easier access to solutions and products.
It is also aligned to the EU Cancer Mission declared by the European Commission last year, which suggested that taking interdisciplinary approaches could be the key to accelerating cancer research and finding new treatment options.