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AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $237 billion and impressive 82% gross profit margin, announced today that its immunotherapy drug, Imfinzi (durvalumab), has been approved by the European Union for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). According to InvestingPro analysis, AstraZeneca (NASDAQ:AZN) maintains a "GREAT" financial health score, positioning it strongly for continued market expansion. This approval marks a significant milestone as Imfinzi becomes the first immunotherapy option for LS-SCLC patients in Europe.
The European Commission’s decision is grounded on the positive results from the ADRIATIC Phase III trial, which demonstrated a 27% reduction in the risk of death compared to placebo. The trial outcomes were recently published in The New England Journal of Medicine.
Small cell lung cancer is a particularly aggressive form of the disease, with LS-SCLC often recurring and progressing rapidly despite initial responses to CRT. The prognosis for LS-SCLC has been historically poor, with only 15-30% of patients surviving five years post-diagnosis.
Suresh Senan, PhD, a principal investigator in the ADRIATIC trial, highlighted the approval as a pivotal moment for European patients, citing the trial’s finding that 57% of patients treated with durvalumab were still alive at three years, setting a new standard in a treatment landscape that has seen little change over decades.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, emphasized Imfinzi’s potential to transform LS-SCLC treatment, noting that it is now the only immunotherapy approved for both early and late-stage disease in Europe.
Imfinzi has also shown to reduce the risk of disease progression or death by 24% versus placebo, with a median progression-free survival (PFS) of 16.6 months compared to 9.2 months for placebo. The safety profile of Imfinzi was generally manageable and in line with the known profile of the medicine, with no new safety concerns identified.
Already approved in the US and other regions based on the ADRIATIC results, Imfinzi is under review in Japan and several other countries for this indication. It is also approved in combination with chemotherapy for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial.
This approval is based on a press release statement and adds to AstraZeneca’s growing portfolio in the lung cancer segment, as the company continues to focus on innovative treatments that could potentially redefine cancer care and improve patient outcomes. While trading at a premium valuation with a P/E ratio of 33.8, AstraZeneca’s robust pipeline and market position make it an interesting stock to watch. For deeper insights into AstraZeneca’s valuation and growth prospects, including 12 additional ProTips and comprehensive financial analysis, visit InvestingPro to access the detailed Pro Research Report.
In other recent news, AstraZeneca PLC has announced the acquisition of biotechnology firm EsoBiotec for up to $1 billion, aimed at enhancing its cell therapy capabilities. The deal includes EsoBiotec’s Engineered NanoBody Lentiviral (ENaBL) platform, which could simplify the administration of cell therapies. This acquisition is expected to close in the second quarter of 2025 and will not impact AstraZeneca’s financial guidance for that year. Additionally, AstraZeneca’s Chief Executive Officer, Pascal Soriot, acquired 89,962 ordinary shares following the vesting of a performance-based award, as part of the AstraZeneca Performance Share Plan. The company also reported positive results from its MATTERHORN Phase III trial, where Imfinzi (durvalumab) combined with chemotherapy showed significant improvements in event-free survival for gastric cancer patients. This trial marks the first global Phase III study to demonstrate superior results with an immunotherapy combination over standard care in this setting. AstraZeneca has scheduled its 2025 Annual General Meeting for April 11, with a digital participation option for shareholders. The agenda includes routine corporate matters and a proposal to reduce the notice period for general meetings.
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