CHMP Backs AstraZeneca's Tagrisso Combo for Advanced Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) has received a recommendation from the European Medicines Agency’s human medicines committee as an element of combination therapy for certain advanced lung cancer patients. Specifically, the Committee for Medicinal Products for Human Use (CHMP) has endorsed the use of Tagrisso, an epidermal growth factor receptor-mutated (EGFR) tyrosine kinase inhibitor, in conjunction with pemetrexed and platinum-based chemotherapy. This recommendation applies to adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), particularly those with exon 19 deletions or exon 21 (L858R) mutations.

This positive recommendation by the committee is based on data from the late-stage FLAURA2 trial. This trial included over 500 patients who were randomized to either receive a combination of Tagrisso and chemotherapy or just Tagrisso, which is the current global standard of care for these patients. The results demonstrated that the combination therapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone.

Additionally, the combination therapy showed an increase in median progression-free survival by 8.8 months and a progression-free survival by 9.5 months compared to Tagrisso monotherapy. While the overall survival data were not fully mature at the time of interim analysis, there was an "encouraging trend" indicating potential overall survival benefit with the combination treatment versus Tagrisso alone.

Lung cancer affects over 450,000 individuals annually in Europe, with up to 85% of these cases being NSCLC. Within this group, up to 15% of NSCLC patients in Europe have an EGFR mutation, a patient population that is highly responsive to treatment with EGFR-tyrosine kinase inhibitors, which hinder the cell-signalling pathways that promote tumor growth.

Tagrisso is already approved as a monotherapy in more than 100 countries. It is authorized for first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and as an adjuvant treatment for early-stage EGFR-mutated NSCLC.

Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, emphasized that the CHMP’s latest endorsement reinforces the significance of Tagrisso as a fundamental therapy in treating EGFR-mutated lung cancer. She also mentioned that if the drug gets approval in Europe, patients will have the flexibility to choose between Tagrisso alone or in combination with chemotherapy. This is particularly crucial for patients whose disease has metastasized to the brain or those with L858R mutations.

In summary, the CHMP’s recommendation introduces a new treatment paradigm for a subset of lung cancer patients, offering them a potentially more effective first-line therapy option. This combination approach, supported by robust clinical trial data, aims to improve the outcomes for patients battling advanced stages of EGFR-mutated NSCLC.