The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving AstraZeneca‘s Tagrisso, in combination with chemotherapy, for the first-line treatment of adults with non-small cell lung cancer (NSCLC).
The Tagrisso regimen is intended for treating patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) NSCLC whose tumours exhibit exon 19 deletions or exon 21 (L858R) mutations.
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The committee’s positive opinion is based on results from the open-label, randomised, multicentre, international Phase III FLAURA2 clinical trial.
This study assessed Tagrisso in combination with pemetrexed and platinum-based chemotherapy in 557 patients across 150 centres in 20 countries.
Patients in the trial received 80mg of Tagrisso once daily, along with pemetrexed and a choice of cisplatin or carboplatin every three weeks for four cycles, followed by maintenance therapy with Tagrisso and pemetrexed.
Progression-free survival (PFS) was the trial’s primary endpoint while overall survival (OS) is being evaluated as a secondary endpoint.
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By GlobalDataThe interim trial results demonstrated that the Tagrisso regimen lowered the disease progression or death risk by 38% versus Tagrisso monotherapy.
The median PFS was 25.5 months for the combination therapy, showing an improvement of 8.8 months over the monotherapy, which had a median PFS of 16.7 months.
Although the overall survival data remained immature, with only 41% maturity at the second interim analysis, there is an encouraging trend towards an OS benefit with the combination therapy compared to Tagrisso alone.
The safety profile of the combination therapy was found to be manageable and in line with the known profiles of the individual treatments.
Commenting on the EMA CHMP recommendation, AstraZeneca oncology research and development executive vice-president Susan Galbraith stated: “The news reinforces the importance of Tagrisso as the backbone therapy in EGFR-mutated lung cancer.
“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.”
Tagrisso is already approved in more than 100 countries, including the US, EU, China and Japan, for indications including first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.
In May 2024, AstraZeneca signed a global licence and option agreement with Nona Biosciences for a preclinical monoclonal antibody.
