Merck KGaA and Pfizer Inc.'s immunotherapy Bavencio failed to improve survival in patients with a certain type of lung cancer who had previously been treated with chemotherapy.
The phase 3 study, called Javelin Lung 200, investigated Bavencio, or avelumab, in comparison with chemotherapy drug docetaxel in non-small cell lung cancer patients whose cancer had spread after receiving another type of chemotherapy.
Results of the trial, which included 792 patients, did not meet the target of extending the lives of patients with tumors that tested positive for the PD-L1 protein, which plays a role in suppressing the immune system.
According to Merck KGaA and Pfizer, the proportion of patients in the chemotherapy arm crossing over to immune checkpoint inhibitors outside the study was higher than previously reported in immunotherapy clinical trials after platinum-based chemotherapy and this may have confounded this trial outcome.
Immune checkpoint inhibitors are drugs that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells.
However, the study saw an improvement versus the control arm in extension of lives of patients whose tumors had a 50% or greater PD-L1 expression, who represented about 40% of the study population, and patients whose tumors had an 80% or greater PD-L1 expression, representing roughly 30% of the study population.
Merck KGaA and Pfizer formed a strategic alliance to co-develop and co-commercialize Bavencio in November 2014.
The U.S. Food and Drug Administration has approved Bavencio for a certain type of skin cancer and cancers of the urinary system. The drug secured breakthrough therapy designation from the FDA as a combination therapy for certain patients with advanced kidney cancer.