The Medicines and Healthcare products Regulatory Agency (MHRA) has approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer (NSCLC)
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for around 80-85% of 100 cases. It can be one of three types: squamous cell carcinoma, adenocarcinoma, or large-cell carcinoma.
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor (EGFR) and who have not yet received treatment for their cancer, which has spread to other parts of the body (metastatic cancer).
Aumolertinib reduced the risk of disease progression or death by 54%
Aumolertinib blocks EGFR, helping to slow or stop the growth of lung cancer and potentially decreasing tumour size.
EGFR is a protein expressed on the surface of cells that helps them grow and divide. In NSCLC, a mutation in a gene causes the EGFR to remain stuck in the “on” position, driving abnormal cell growth.
In the phase 3 clinical trial, aumolertinib reduced the risk of disease progression or death by 54% in patients with advanced or metastatic NSCLC who had specific EGFR mutations when compared to an already-approved cancer treatment called gefitinib. This means that aumolertinib significantly outperformed gefitinib, offering a substantial improvement in patient outcomes.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: “Patient safety is our top priority, and I’m pleased to confirm that aumolertinib has met the MHRA’s standards for safety, quality and effectiveness.
“This approval offers a new treatment option for patients with advanced non-small cell lung cancer who have tested positive for EGFR mutations – a group for whom targeted therapies can be vital.
“As with all products, we will keep aumolertinib’s safety under close review.”
Trial shows longer progression-free survival and fewer side effects
Before aumolertinib’s approval, first-line treatments for EGFR-mutant NSCLC included gefitinib, erlotinib, and osimertinib. While these drugs have improved outcomes, resistance often develops. Aumolertinib has shown promising efficacy and a manageable safety profile, positioning it as a competitive alternative with the potential for significantly improved progression-free survival, offering hope to patients.
A clinical trial called AENEAS, a large-scale and rigorously conducted study, included 429 patients with advanced non-small cell lung cancer (NSCLC) who had not received any previous treatment. The study compared two drugs: aumolertinib and gefitinib. Patients who took aumolertinib lived longer without their cancer getting worse. On average, their cancer did not grow for 19.3 months, compared to just 9.9 months for those taking gefitinib. This means aumolertinib cuts the risk of cancer progression or death by more than half.
Both drugs had similar success in shrinking tumours. About 74% of patients taking aumolertinib and 72% taking gefitinib saw their tumours shrink. However, the response lasted significantly longer with aumolertinib—about 18 months, compared to just over 8 months for gefitinib, providing reassurance about its effectiveness.
Side effects were also looked at. Serious side effects happened at about the same rate in both groups. However, common problems like skin rash and diarrhoea were less frequent with aumolertinib. Only 23% of patients experienced a rash, and 16% had diarrhoea, compared to 41% and 36% of patients on gefitinib, respectively.
Overall, the trial showed that aumolertinib is more effective and better tolerated than gefitinib for treating this type of lung cancer.
