Double vision for AZ with twin success in lung cancer and kidney disease
Cambridge Big BioTech AstraZeneca has notched notable successes with potential cures for small lung cancer and chronic kidney disease.
AstraZeneca's Imfinzi (durvalumab) medicine has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer.
On the second front, the company reveals it is able to halt a Farxiga Phase III DAPA-CKD trial early after overwhelming efficacy in patients with chronic kidney disease.
Imfinzi first: The approval by the US Food and Drug Administration was based on positive results from the Phase III CASPIAN trial showing that Imfinzi in combination with SoC platinum-etoposide demonstrated a statistically significant and clinically meaningful improvement in overall survival versus SoC alone.
Dave Fredrickson, executive VP for AstraZeneca’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.”
Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, UCLA Medical Center, Santa Monica, California and a lead investigator in the Phase III CASPIAN trial, added: "Patients with extensive-stage small cell lung cancer continue to face a poor prognosis, and finding new medicines to improve outcomes in this setting has been a formidable challenge.
“The CASPIAN trial enables clinicians to choose durvalumab in combination with etoposide and either carboplatin or cisplatin, making this an important new 1st-line treatment option for patients that is both effective and well-tolerated.”
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one fifth of all fatalities through this iteration of the disease.
AstraZeneca’s truncated Farxiga Phase III DAPA-CKD trial is further good news for the Cambridge Biomedical Campus business.
Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics.
The trial is being stopped early following a recommendation from an independent Data Monitoring Committee based on its determination of overwhelming efficacy.
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.
Mene Pangalos, executive VP, BioPharmaceuticals R & D, said: “Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the Data Monitoring Committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world.”
The full results will be submitted for presentation at a forthcoming medical meeting and AstraZeneca will now initiate discussions with global health authorities regarding early regulatory submissions.