FDA Approves Tagrisso (Osimertinib) for Unresectable Stage III EGFR-Mutated Non-Small Cell Lung Cancer

Oct 16, 2024 17:30 CST Updated 17:30

AstraZeneca

Biopharmaceutical Manufacturer

On September 25, 2024, the U.S. FDA approved AstraZeneca's Tagrisso (osimertinib) for the treatment of adult patients with locally advanced, unresectable (Stage III) non-small cell lung cancer (NSCLC).

Tagrisso Key Studies

This FDA approval is based onLAURA（NCT03521154）Positive results from the trial. LAURA is a global, multicenter, double-blind, randomized, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of osimertinib in patients with locally advanced, unresectable (Stage III) NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiation therapy and whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations. These patients were confirmed to be positive for EGFR sensitizing mutations using an FDA-approved testing method.

The research results show that,Osimertinib demonstrated significant clinical benefits in treating this type of patient.。Compared with the placebo group, the progression-free survival (PFS) of patients in the osimertinib group was significantly improved.`, with a low risk ratio down to`0.16(95% CI: 0.10, 0.24; p-value<0.001). The median PFS for patients in the osimertinib group was39.1 months(95% CI: 31.5, Not Estimable [NE]), whereas in the placebo group it was only5.6 months(95% CI: 3.7, 7.4). This result indicates that osimertinib has a significant advantage in prolonging patient survival.

Although the data for overall survival (OS) are not yet mature, the observed results do not indicate a harmful trend in survival for the osimertinib group. Furthermore, the safety profile of osimertinib is consistent with the established profile, with no new safety concerns identified. The most common adverse reactions include lymphopenia, leukopenia, interstitial lung disease/pneumonia, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.

Dave Fredrickson, Executive Vice President of AstraZeneca's Oncology Business Unit, stated: "The approval of Tagrisso for the treatment of Stage III unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for this patient population, who previously had no option for targeted therapy. The results of the LAURA trial demonstrate that Tagrisso has a powerful impact as a cornerstone therapy for this disease, and with this approval, patients with EGFR-mutated non-small cell lung cancer at all stages can now benefit."

Tagrisso（osimertinib）

Tagrisso (osimertinib, 奥希替尼)It is an orally administered small-molecule third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

Mainly used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR mutations. Particularly suitable for patients who have experienced disease progression during or after treatment with epidermal growth factor receptor tyrosine kinase inhibitors (TKIs) and have been confirmed to have positive EGFR T790M mutations through testing.

Tagrisso has conducted multiple clinical trials worldwide to evaluate its efficacy and safety in patients with NSCLC at different stages. Among them, the OCEAN study and the ADAURA study have respectively confirmed the significant efficacy of Tagrisso in treating patients with brain metastases who have not undergone radiotherapy and in adjuvant therapy after surgery.

Non-Small Cell Lung Cancer

More than 200,000 people are diagnosed with lung cancer in the United States each year, of which 80-85% are non-small cell lung cancer (NSCLC), and approximately15% of NSCLC patients have EGFR mutations. This approval is undoubtedly a significant piece of good news for these patients, offering them the opportunity to achieve longer survival and a better quality of life through osimertinib.