Merck KGaA and Pfizer Inc. said their medicine Bavencio helped improve the overall survival of patients with a type of bladder cancer, meeting the main goal of a late-stage study called Javelin Bladder 100.
Bavencio was approved in the U.S. under an accelerated pathway in 2017 as a treatment for urothelial carcinoma that has progressed after chemotherapy, though the companies were asked to conduct a so-called confirmatory study to receive full approval. The companies undertook the Javelin Bladder 100 study for that purpose.
Under the U.S. Food and Drug Administration's accelerated pathway, therapies that are likely to treat a serious condition but may require an extended period of time to study are approved based on a surrogate endpoint — such as a laboratory measurement, radiographic image, physical sign or other measure — that is considered reasonably likely to predict the clinical benefit of a drug.
German pharmaceutical giant Merck KGaA and New York-based Pfizer studied whether Bavencio helped bolster the effects of chemotherapy as a maintenance therapy in previously untreated patients with urothelial carcinoma whose disease has spread to nearby tissues or to other parts of the body.
Based on an interim analysis, the companies said Bavencio helped improve survival rate in patients compared to those that did not receive the medicine.
Maintenance therapy is a treatment that is designed to help a primary therapy — in this case chemotherapy — succeed. Urothelial carcinoma is the most common type of bladder cancer, and chemotherapy is the first line of defense for patients with advanced disease. Despite high initial response rates, patients ultimately experience disease progression within nine months after the initiation of treatment.
Bavencio, which is approved in the U.S. and Europe to treat a type of kidney cancer, previously failed in a trial as an initial maintenance treatment and as a third-line therapy for patients with a type of gastric cancer. The companies also discontinued a late-stage study of Bavencio in patients with ovarian cancer after the medicine failed to prolong their lives.