Cambridge: AstraZeneca said on Monday its drug Imfinzi failed to meet the main goal of improving overall survival compared with platinum-based chemotherapy as a monotherapy treatment of patients with late-stage non-small cell lung cancer.
Imfinzi, in a Phase III trial called ‘PEARL’, failed in patients whose tumour cells express high levels of PD-L1, or in a subgroup of patients at low risk of early mortality, AstraZeneca said in a statement.
Imfinzi belongs to the immunotherapy class of treatments that boost the body’s own defences to fight cancer by using antibodies that block or bind to foreign substances in the body.
PD-L1 is found on the surface of many cancer cells and impairs the immune system’s ability to fight the disease.
AstraZeneca said there was improvement in overall survival with Imfinzi monotherapy in a subset of patients with PD-L1 tumour expression greater than 50 per cent, a secondary goal of the study, which was mainly conducted in Asia.
“We are encouraged to see patients in the metastatic setting at a higher level of PD-L1 tumour expression demonstrate the most benefit with Imfinzi monotherapy treatment, as is commonly seen in this class,” said Susan Galbraith, executive vice-president, oncology R&D at AstraZeneca.
Last month, AstraZeneca’s lung cancer drugs Imfinzi and Imjudo were approved by the U.S. Food and Drug Administration when used along with chemotherapy for treatment of adults with stage IV non-small cell lung cancer.
In a separate statement on Monday, AstraZeneca’s diabetes drug Forxiga was recommended for approval by the European Medicines Agency’s human medicines committee (CHMP) for symptomatic chronic heart failure.