The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive recommendation for AstraZeneca's Tagrisso (osimertinib) for the treatment of adult patients with unresectable, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). This decision marks a significant step forward in providing a targeted therapy option for patients in Europe facing this challenging condition.
The CHMP's recommendation is based on the results of the Phase III LAURA trial, which were published in The New England Journal of Medicine. The trial demonstrated a significant improvement in progression-free survival (PFS) for patients treated with Tagrisso compared to placebo. Specifically, Tagrisso reduced the risk of disease progression or death by 84% (HR 0.16; 95% CI: 0.10-0.24; p<0.001) as assessed by blinded independent central review. The median PFS was 39.1 months in the Tagrisso arm versus 5.6 months in the placebo arm.
Clinical Impact and Expert Commentary
Dr. Manuel Cobo, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital in Malaga, Spain, and an investigator in the LAURA trial, emphasized the importance of these findings. "The LAURA results build on the established efficacy of osimertinib and support the approval of the first targeted therapy for patients with unresectable, EGFR-mutated lung cancer," he stated. "The positive recommendation marks an important step towards offering patients in Europe a targeted treatment option that can extend the time before their disease progresses by more than three years."
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, highlighted Tagrisso's role as a foundational therapy in EGFR-mutated NSCLC. "The news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting," she said. "Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."
Disease Burden and Unmet Needs
Lung cancer remains a significant health challenge in Europe, with over 450,000 new cases diagnosed each year. Among those with NSCLC, 10-15% of patients in Europe have tumors with an EGFR mutation. Nearly one in five people with NSCLC have an unresectable tumor, highlighting the need for effective treatment options in this specific patient population.
Trial Design and Safety Profile
The LAURA trial evaluated Tagrisso following chemoradiotherapy (CRT) in patients with unresectable, Stage III EGFR-mutated NSCLC. The safety and tolerability profile of Tagrisso in the LAURA trial was consistent with its established profile, and no new safety concerns were identified.
Tagrisso is already approved as monotherapy in more than 100 countries, including the US, EU, China, and Japan, for various indications in EGFR-mutated NSCLC, including first-line treatment, treatment of T790M mutation-positive NSCLC, and adjuvant treatment of early-stage disease. It is also approved in combination with chemotherapy in some regions.
