AstraZeneca has obtained Health Canada’s Notice of Compliance (NOC) for Tagrisso (osimertinib) along with pemetrexed and platinum-based chemotherapy, to treat epidermal growth factor receptor (EGFR)-mutated lung cancer.
The approval is intended for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
Health Canada’s decision is based on the FLAURA2 Phase III clinical trial, which demonstrated a 38% reduction in the risk of disease progression or death when Tagrisso was combined with chemotherapy, compared to Tagrisso monotherapy.
The randomised, open-label, multi-centre, global trial included 557 patients from 150 centres in 20 countries, three of which were in Canada.
Patients treated with the combination therapy experienced a median progression-free survival (PFS) of 25.5 months - an 8.8-month improvement over the 16.7 months observed with Tagrisso monotherapy.
The safety profile of the combined treatment was in line with the known profiles of the individual medicines. Adverse event rates were higher in the combination arm, attributable to the chemotherapy components.
However, discontinuation rates due to adverse events were low for both treatment arms.
The most common adverse reactions observed were decreases in leukocytes, platelets and neutrophils, along with rash and diarrhoea. Adverse reactions at grade 3 and above included significant decreases in neutrophils and leukocytes.
The primary endpoint of the ongoing trial is PFS, and it will continue to evaluate overall survival as a secondary endpoint.
University of British Columbia medicine clinical professor and medical oncologist Dr Barbara Melosky stated: “The FLAURA2 trial showed results demonstrating that patients experienced a significantly longer time without progression than those patients on standard of care.
“This approval is great news for physicians and patients and further helps us to match the right patient to the right treatment to get the best possible outcomes.”
Tagrisso, a third-generation EGFR-TKI, has been used in treating 850,000 patients worldwide.
It has shown efficacy in NSCLC, including against central nervous system metastases.
In June 2024, the Japanese Pharmaceuticals and Medical Device Agency approved Tagrisso (osimertinib) plus chemotherapy as a first-line treatment for adults with NSCLC.
