New horizons….
Furmonertinib: a promising treatment following resistance to prior TKI therapy!
Furmonertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that has shown promise in the treatment of EGFR-positive non-small cell lung cancer (NSCLC).
Furmonertinib is being developed by ArriVent BioPharma based in the US West Coast. It is a novel, third-generation EGFR TKI with activity against typical common EGFR mutations and, unusually, EGFR exon 20 insertions and other rare EGFR mutations. Some call it the ‘Swiss army knife’ as it seems to be efficacious across more mutations than any other TKI developed so far. It was granted fast-track designation by the FDA in June 2022, and ArriVent is launching a series of trials, including 2 in the UK:-
FURMO-004: phase 3 trial focusing on first line Exon 20 insertion. Recruiting in the UK mid-year. 3 arm trial :furmonertinib: 240mg, 160mg, platinum-based chemotherapy
FURMO-002: phase 1b trial focusing on metastatic previously treated patients. 4 groups; EGFR Exon 20 insertion,HER2 mutation, patients who have progressed on Osimertinib, uncommon mutations
Furmonertinib has shown significant clinical activity against EGFR-mutant NSCLC in preclinical studies and clinical trials. In a phase I/II study and most exciting for us, furmonertinib demonstrated a high response rate and durable responses in patients with EGFR-mutant NSCLC who had progressed on prior EGFR TKI therapy.
Furmonertinib is also shown promising efficacy against NSCLC brain metastases, which are a common complication of advanced NSCLC. In a phase II study, furmonertinib demonstrated a high response rate and prolonged progression-free survival in patients with EGFR-mutant NSCLC and brain metastases.
Overall, furmonertinib is a promising treatment option for patients with EGFR-positive NSCLC, particularly those who have progressed on prior EGFR TKI therapy or have brain metastases.
Opportunity to influence the speed of drug approval in the UK
Drug development is happening at an unprecedented pace and there is a lot of activity in the area of Lung Cancer. The current situation faced by NICE is one of the increasing volume of appraisals and multiple appraisals in the same disease area.
Faced with the increasing number of new drugs coming to appraisal, the unacceptably long time taken to the appraisal decision and the lack of flexibility in the existing process, there is an immediate need to scale processes to meet demand, offer faster access and guidance, build a process where new medicines will be available more quickly and ensure medicines still go through the same rigorous evaluation. To achieve this, the focus needs to be on adapting ways of working to meet changing needs and priorities.
NICE have been working with a Voluntary and Community Sector (VCS) Forum to consult on this ‘proportionate approach to technology appraisals’ (PATT). This is the process by which a new drug or treatment is approved for use and funding in the NHS. 11 of the charities involved in the VCS Forum were invited to be part of the PATT Patient Advisory Group (PAG) and we are one of these charities. Our involvement began in November last year and will continue throughout this year. In that time, we will help to shape patient involvement in the technical appraisal and guidance processes.
The ambition continues to be: getting the best care to people, fast, whilst ensuring value for the taxpayer. The aspiration to increase capacity will be achieved by making the best use of resources, people and patients and accessing promising treatments more quickly.
All of this must be achieved whilst being user-centred: putting people with lived experience at the heart of what NICE does. We are pleased to be part of the patient advisory process through which we can influence the NICE organisational objectives and ensure the patient’s involvement and voice is not dimmed.