(Alliance News) - AstraZeneca PLC on Monday said its Andexxa phase four trial will be stopped early after achieving positive efficacy data.
The Cambridge, England-based pharmaceutical company came to the decision after the study, which followed 450 patients on Xa inhibitors, showed Andexxa's reversal benefits on potential life-threatening bleeds in the brain earlier than originally anticipated.
The decision to stop the trial was recommended by the independent Data & Safety Monitoring Board.
Xa inhibitors are anticoagulants used to prevent blood clots, deep vein thrombosis and strokes in people with atrial fibrillation, an abnormal heart rhythm. However, the anticoagulant effect can cause life-threatening or uncontrolled bleeding. Andexxa is a protein, designed to rapidly reverse anticoagulation effects to treat life-threatening or uncontrolled bleeding.
AstraZeneca also noted that subsequently, Andexxa will convert to full label approval in the US and the European Union. The treatment had already been granted accelerated approval in the US, and conditional approval in the EU, SWitzerland, the UK and Japan as Ondexxya.
Stuart J Connolly, senior scientist at Population Health Research Institute and professor at McMaster University said: "We are pleased that the study has met its efficacy endpoint at the planned interim analysis, showing improved control of bleeding with targeted anticoagulation reversal, compared to usual care. We look forward to sharing the full efficacy and safety results after further analysis, with the hope that the data will pave the way for further guidance on the treatment of potentially life-threatening bleeds."
This comes after AstraZeneca on Sunday announced results from its Adaura phase three trial showed Tagrisso, or osimertinib, reduced the risk of death for patients with locally advanced or metastatic EGFRm non-small cell lung cancer, by more than a half.
EGFRm stands for epidermal growth factor receptor mutant.
AstraZeneca said that in the overall trial population, as estimated 88% of patients treated with Tagrisso were alive at five years, compared to 78% on placebo.
Deputy Director & Chief of Medical Oncology at YaleCenter Roy S Herbst said: "These highly anticipated overall survival results, with 88% of patients alive at five years, are a momentous achievement in the treatment of early-stage EGFR-mutated lung cancer. These data underscore that adjuvant treatment with osimertinib provides patients with the best chance of long-term survival."
Tagrisso is approved as monotherapy in countries including in the US, EU, China and Japan.
On Saturday, AstraZenenca also reported positive results from the planned interim analysis of a phase three trial evaluating the combination of Lynparza and Imfinzi with chemotherapy and bevacizumab.
The trial demonstrated a "statistically significant and clinically meaningful improvement in progression-free survival" in newly diagnosed patients with ovarian cancer, reducing the relative risk of disease progression or death by 51% versus chemotherapy and bevacizumab alone.
Bevacizumab is a type of targeted cancer drug treatment.
On Friday, AstraZeneca had also reported positive results from planned interim analysis of a phase three trial evaluating its Imfinzi drug in gastric and gastroesophageal junction cancers.
Shares in AstraZeneca were up 0.5% at 11,804.00 pence each in London on Monday morning.
By Sabrina Penty, Alliance News reporter
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