AstraZeneca’s TAGRISSO® (osimertinib), in combination with chemotherapy, has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Following a Priority Review, the FDA based its approval on the results from the Phase III FLAURA2 trial, which demonstrated a significant extension in median progression-free survival (PFS) with the TAGRISSO combination versus TAGRISSO monotherapy.
The FLAURA2 trial findings revealed that TAGRISSO plus chemotherapy reduced the risk of disease progression or death by 38%, with PFS results showing median survival improvement by nearly 9 months over monotherapy. These outcomes were consistent across PFS assessments, indicating robust evidence for the efficacy of the combination.
NSCLC is the most prevalent form of lung cancer, accounting for the majority of diagnoses. In the US, approximately 15% of NSCLC patients have an EGFR mutation. This approval offers these patients an important new treatment option that has demonstrated the ability to delay disease progression, particularly beneficial for patients with a poorer prognosis, such as those with brain metastases or L858R mutations.
Pasi A. Jänne, principal investigator of the trial, emphasized the significance of this advancement in providing osimertinib-based treatment regimens, allowing physicians to optimize treatment plans and potentially achieve better patient outcomes.
Dave Fredrickson of AstraZeneca noted that this approval sets a new benchmark for PFS in first-line advanced EGFRm NSCLC treatment, solidifying TAGRISSO as the cornerstone of treatment in this setting, irrespective of the treatment approach.
Laurie Ambrose of GO2 for Lung Cancer celebrated this progress in offering more personalized treatment options to the lung cancer community, focusing on delivering the right treatments at the right time to improve outcomes.
The continued follow-up results from the FLAURA2 trial are a testament to the ongoing pursuit of innovative and impactful treatment options for NSCLC patients, contributing to the collective goal of improving survival and quality of life within the lung cancer community.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
