TAGRISSO® and Chemotherapy Combo Approved for EGFR-Mutated Lung Cancer
AstraZeneca’s TAGRISSO® (osimertinib) combined with chemotherapy has secured approval in the US for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The FDA’s approval, granted after a Priority Review, stems from findings in the FLAURA2 Phase III trial published in The New England Journal of Medicine. The addition of chemotherapy to TAGRISSO demonstrated a 38% reduction in the risk of disease progression or death compared to TAGRISSO monotherapy, the established 1st-line global standard of care.
Median progression-free survival (PFS) by investigator assessment stood at 25.5 months with TAGRISSO plus chemotherapy, showcasing an 8.8-month improvement over TAGRISSO monotherapy. Blinded independent central review (BICR) confirmed these results, with TAGRISSO plus chemotherapy demonstrating a 9.5-month improvement in median PFS over monotherapy.
In the US, more than 200,000 individuals are diagnosed with lung cancer annually, with 80-85% of cases attributed to NSCLC. Approximately 70% of patients are diagnosed at an advanced stage, and around 15% of NSCLC patients harbor an EGFR mutation.
Dr. Pasi A. Jänne, principal investigator for the FLAURA2 trial, hailed the approval as a critical addition to the treatment arsenal for advanced EGFR-mutated NSCLC patients. He emphasized the significance of offering two highly effective osimertinib-based options, enabling physicians to tailor treatment to individual patient needs.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted the substantial delay in disease progression offered by the new treatment option. He underscored TAGRISSO’s position as a cornerstone of EGFR-mutated lung cancer treatment, either as monotherapy or in combination with chemotherapy, particularly beneficial for patients with a poorer prognosis.
Laurie Ambrose, President and CEO of GO2 for Lung Cancer, expressed excitement over the continued progress in advancing personalized treatment options. She emphasized the importance of targeted treatments for better outcomes in the lung cancer community.
Results from a prespecified exploratory analysis in FLAURA2 patients with brain metastases at baseline revealed that TAGRISSO plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to TAGRISSO alone.
While overall survival (OS) results remained immature at the second interim analysis, no detrimental trends were observed. The safety profile of TAGRISSO with chemotherapy addition was generally manageable and consistent with established profiles of individual medicines.
The approval of TAGRISSO with chemotherapy addition reinforces its status as a preferred treatment option for EGFR-mutated NSCLC patients, offering significant benefits in disease management and potentially improving patient outcomes.
