EC approves AstraZeneca’s Tagrisso with chemotherapy for EGFR-mutated lung cancer

AstraZeneca has received approval from the European Commission (EC) to use its cancer drug, Tagrisso (osimertinib), in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This approval is specifically for patients whose tumors exhibit exon 19 deletions or exon 21 (L858R) mutations.

The decision by the European authorities follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on the results from the FLAURA2 Phase III trial, which were published in The New England Journal of Medicine. In the trial, the combination of Tagrisso with chemotherapy demonstrated a significant reduction in the risk of disease progression or death. The study showed that this combination reduced the risk by 38% compared to Tagrisso monotherapy, which is currently the global standard of care.

Patients treated with the combination therapy had a median progression-free survival (PFS) of 25.5 months, which is an improvement of 8.8 months over those who received Tagrisso alone. Additionally, for patients with brain metastases, the combination therapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to monotherapy.

David Planchard, MD, PhD, a thoracic oncologist at the Gustave Roussy Institute of Oncology and the principal investigator for the trial, remarked, “Today’s news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new first-line treatment option that combines osimertinib with chemotherapy. The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in progression-free survival.”

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, emphasized the broader impact of the approval, stating, “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy. This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.”

The safety profile of the combination therapy aligns with the known effects of the individual treatments. However, adverse events were more common in the combination therapy group, reflecting typical chemotherapy-related effects. Discontinuation rates due to adverse events were 11% for the combination therapy, compared to 6% for monotherapy.

Tagrisso is approved in over 110 countries for various stages of NSCLC treatment, including the US, EU, China, and Japan. It is under further global review for other potential indications, continuing AstraZeneca’s commitment to expanding its applications.

The approval of Tagrisso plus chemotherapy offers a new hope for patients with advanced NSCLC, providing a more effective treatment option that could potentially extend lives and improve quality of life. As the trial continues, with a focus on overall survival as a key secondary endpoint, the oncology community eagerly anticipates further data that could solidify the role of this therapy in first-line treatment regimes.