30th Mar 2020 09:03
(Alliance News) - AstraZeneca PLC on Monday reported that a phase 3 Farxiga kidney disease trial will end early due to "overwhelming efficacy", while drug Imfinzi was approved in the US to treat extensive-stage small cell lung cancer.
Imfinzi was approved by the US Food & Drug Administrations as a first-line treatments for adults with extensive-stage small cell lung cancer when combined "with standard-of-care chemotherapies, etoposide plus either carboplatin or cisplatin".
The US approval was based on positive results from the drug maker's phase 3 Caspian trial.
Dave Fredrickson, executive vice president of Astra's Oncology Business Unit, said: "The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options. Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease."
Further, Astra's phase 3 Dapa-CKD trial is to be stopped early at the recommendation of an independent data monitoring committee thanks to its "overwhelming efficiency" in chronic kidney disease.
"The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Farxiga's benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial," Astra said.
On Saturday, Astra separately reported positive data from its phase 3 Dapa-HF trial of Farixga in heart failure, showing the drug reduced the incidence of worsening heart failure or cardiovascular death.
The phase 3 Dapa-HF trial found that Farixga, which contains dapagliflozin: "Reduced the incidence of the primary composite endpoint of heart failure worsening or cardiovascular death compared to placebo, in patients with heart failure with reduced ejection fraction, irrespective of their background therapy."
The drug was evaluated with patients taking "a broad range of pharmacological treatments", as well as device and cardiac resychronisation therapy.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astra, said: "These new data from the Dapa-HF trial further reinforce Farxiga's clinical effects beyond diabetes. By reducing the risk of heart failure worsening regardless of background therapy, Farxiga has the potential to improve current standard of care and reduce the burden of disease for heart failure patients across the globe."
Shares in Astra were down 0.1% at 6,797.00 pence in London on Monday morning.
By Anna Farley; [email protected]
Copyright 2020 Alliance News Limited. All Rights Reserved.
Related Shares:
Astrazeneca