FDA approves AZ Imfinzi in new lung cancer use

AstraZeneca has reported a double win after the FDA approved its Imfinzi for a form of lung cancer, and it stopped a trial of its Farxiga after showing “overwhelming efficacy” in chronic kidney disease.

Imfinzi’s approval in untreated extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide or either carboplatin or cisplatin means that the immunotherapy will take on Roche’s Tecentriq (atezolizumab).

Tecentriq was approved by the FDA in ES-SCLC last year, but AZ says it may have an advantage as Imfinzi’s label is broader, giving a choice of chemotherapy options.

Imfinzi’s approval by the FDA is based on the phase 3 CASPIAN trial showing Imfinzi combined with standard platinum chemotherapy significantly improved overall survival versus chemotherapy alone.

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.

Merck & Co’s rival immunotherapy Keytruda (pembrolizumab) in January failed to improve overall survival in this indication.

Farxiga trial stopped early

At the same time AZ reported that the phase 3 DAPA-CKD of Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) with and without type 2 diabetes was stopped early after “overwhelming efficacy”.

Results set up a showdown with Eli Lilly/Boehringer Ingelheim’s rival SGLT-2 drug Jardiance (empagliflozin), which the FDA has agreed to fast track through the clinical development process in CKD.

The DAPA-CKD trial was stopped early following a recommendation from the trial’s independent Data Monitoring Committee after a routine interim assessment.

Data collected so far show Farxiga’s displaying benefits earlier than originally anticipated and AZ will begin closing the trial.

The primary endpoint of DAPA-CKD is a composite of worsening renal function or death, and onset of end-stage kidney disease or cardiovascular or renal death in patients with CKD, irrespective of the presence of type 2 diabetes.

AZ is building a franchise in metabolic diseases around Farxiga, which is already FDA approved to reduce hospitalisation for heart failure in patients with type 2 diabetes, and to control blood sugar levels in type 2 diabetes patients.

The FDA gave Farxiga a Fast Track designation in CKD, allowing for a fast six-month review of trial results.

It is also benefiting from the six-month Priority Review with the FDA for patients with heart failure.

Other regulators including the European Medicines Agency are also reviewing clinical trial results in heart failure.