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WILMINGTON - AstraZeneca’s TAGRISSO (osimertinib) combined with chemotherapy demonstrated a statistically significant improvement in overall survival compared to TAGRISSO alone for patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer, according to final results from the FLAURA2 Phase III trial. The announcement comes from AstraZeneca (AZN), a prominent player in the pharmaceuticals industry with a market capitalization of $213 billion and impressive gross profit margins of 82%.
The survival benefit was consistent with interim results previously reported and builds on earlier data showing the combination achieved the longest-reported median progression-free survival in this treatment setting.
"These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer," said Dr. Pasi Jänne, principal investigator for the FLAURA2 trial and thoracic medical oncologist at Dana-Farber Cancer Institute.
The safety profile of TAGRISSO plus chemotherapy remained manageable with longer follow-up, though adverse event rates were higher in the combination arm due to chemotherapy-related effects. Discontinuation rates due to adverse events were low in both treatment groups.
TAGRISSO plus chemotherapy is already approved in more than 80 countries, including the US, EU, China and Japan, based on earlier results from the FLAURA2 trial.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, noted that the combination "has the potential to help patients live longer while maintaining their quality of life on treatment."
Lung cancer is the leading cause of cancer death globally, with non-small cell lung cancer accounting for 80-85% of cases. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% in Asia have EGFRm NSCLC. According to InvestingPro data, AstraZeneca has demonstrated strong revenue growth of 15.5% over the last twelve months, positioning it well in this crucial market. The company’s stock is currently trading near its 52-week low, and InvestingPro analysis suggests it may be undervalued based on its Fair Value assessment.Want deeper insights? InvestingPro subscribers have access to 10+ additional expert tips and comprehensive financial metrics for AstraZeneca, along with detailed Pro Research Reports that transform complex Wall Street data into actionable intelligence.
The company said detailed results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide, according to the press release statement. With its next earnings report due in 8 days, investors can access comprehensive analysis and forecasts through InvestingPro’s exclusive research tools and financial health metrics.
In other recent news, AstraZeneca announced that its investigational drug baxdrostat met both primary and secondary endpoints in the BaxHTN Phase III clinical trial for patients with uncontrolled or treatment-resistant hypertension. The trial demonstrated statistically significant reductions in systolic blood pressure compared to placebo, and the drug was generally well tolerated. In addition, the European Commission approved AstraZeneca’s Imfinzi for treating muscle-invasive bladder cancer, following positive results from the NIAGARA Phase III trial. The trial showed a 32% reduction in the risk of disease progression or death with the Imfinzi regimen. AstraZeneca also received accelerated approval from the US FDA for Datroway to treat advanced EGFR-mutated lung cancer, based on results from the TROPION-Lung05 Phase II trial. Datroway showed an objective response rate of 45% in previously treated patients. Meanwhile, AstraZeneca’s Phase III trial of anselamimab in AL amyloidosis did not meet its primary endpoint, though some improvement was noted in a prespecified subgroup. These developments reflect AstraZeneca’s ongoing efforts in advancing treatments across various conditions.
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