AstraZeneca’s (AZ) Tagrisso (osimertinib) has been recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for a subset of advanced lung cancer patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor be authorised for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
The committee’s positive opinion was supported by results from the late-stage FLAURA2 trial, which randomised more than 500 patients to receive Tagrisso plus chemotherapy or Tagrisso monotherapy, the first-line global standard of care for these patients.
The results showed the combination reduced the risk of disease progression or death by 38% compared to Tagrisso alone.
The combination was shown to extend median progression-free survival by 8.8 months and progression-free survival by 9.5 months compared to Tagrisso monotherapy, AZ said, adding that while overall survival data remained immature at the time of the interim analysis, an “encouraging trend” towards overall survival benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone.
More than 450,000 people are diagnosed with lung cancer every year in Europe and NSCLC accounts for up to 85% of all lung cancer cases.
Up to 15% of NSCLC patients in Europe have an EGFR mutation, with this patient population particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth.
Tagrisso is already approved as monotherapy in more than 100 countries, with approved indications including for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and for the adjuvant treatment of early-stage EGFRm NSCLC.
Susan Galbraith, executive vice president, oncology research and development, AZ, said the CHMP’s latest decision on the drug “reinforces the importance of Tagrisso as the backbone therapy in EGFR-mutated lung cancer”.
She continued: “If approved in Europe, patients will have the option to be treated with Tagrisso alone, or with chemotherapy, which is especially important when caring for patients whose disease has spread to the brain or those with L858R mutations.”