Today, AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN) announced that its drug Imfinzi (durvalumab), when used in combination with chemotherapy, has shown a significant improvement in both event-free survival (EFS) and overall survival (OS) in patients with muscle-invasive bladder cancer (MIBC). The results come from the NIAGARA Phase III trial and mark the first instance where an immunotherapy regimen before and after surgery has extended survival in bladder cancer.
The trial included patients treated with Imfinzi in combination with neoadjuvant chemotherapy before undergoing cystectomy, a surgical procedure to remove the bladder, followed by Imfinzi as adjuvant monotherapy. Standard treatment for MIBC typically involves neoadjuvant chemotherapy and radical cystectomy, but many patients still face high recurrence rates and poor prognosis after surgery.
Professor Thomas Powles, Director of Barts Cancer Centre in London and an investigator in the trial, highlighted the significance of the findings, stating that nearly half of patients with MIBC who receive standard care still suffer from disease recurrence or progression. The addition of durvalumab to chemotherapy before surgery, followed by continued use of durvalumab, has shown to extend patients' lives.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca (NASDAQ:AZN), emphasized the company's strategy to introduce immunotherapy early in cancer treatment. The data from the NIAGARA trial are poised to potentially transform the standard of care for bladder cancer patients, aiming to reduce disease recurrence and improve survival rates.
The safety profile of Imfinzi, both as a neoadjuvant therapy with chemotherapy and as an adjuvant monotherapy, was consistent with known profiles of the individual treatments. No new safety concerns were observed, and the addition of Imfinzi did not increase the rate of discontinuation due to adverse events or compromise the ability of patients to complete surgery.
These results are expected to be presented at an upcoming medical meeting and will be shared with global regulatory authorities. The trial was conducted across 192 centers in 22 countries, including North America, South America, Europe, Australia, and Asia.
Imfinzi works by inhibiting the interaction of the PD-L1 protein with PD-1 and CD80 proteins, releasing the inhibition of immune responses against tumors. It is already a standard of care in other types of cancer, including unresectable, Stage III non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (SCLC).
This information is based on a recent SEC filing by AstraZeneca PLC.
In other recent news, AstraZeneca has made significant strides in the pharmaceutical industry.
AstraZeneca's supplemental New Drug Application for TAGRISSO, aimed at treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated non-small cell lung cancer, has received Priority Review status from the FDA, following successful outcomes from the LAURA Phase III trial.
In company news, AstraZeneca's CEO, Pascal Soriot, transferred a significant number of shares to family members, a move typically seen as a personal estate or financial planning activity
On the analyst front, firms such as Citi, BMO Capital, and Deutsche Bank have maintained positive ratings on AstraZeneca's shares, while Argus has increased the price target due to recent drug approvals and strategic acquisitions. Goldman Sachs and JPMorgan have also issued favorable ratings, citing the company's robust pipeline and business fundamentals.
These are all recent developments in AstraZeneca's journey.
InvestingPro Insights
As AstraZeneca PLC (LSE/STO/Nasdaq: AZN) makes strides in the treatment of muscle-invasive bladder cancer with Imfinzi, investors may find encouragement in the company's financial health and market position. AstraZeneca's market capitalization stands robust at $246.27 billion, reflecting the scale of its operations and investor confidence. The company's dedication to innovation is mirrored by a solid revenue growth of 8.6% over the last twelve months as of Q1 2023, underscoring its ability to expand in a competitive pharmaceuticals market. Additionally, the strong gross profit margin of 82.5% during the same period highlights the company's efficiency in managing production and operational costs.
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