Merck Biopharma Korea and Pfizer Pharma Korea said their immuno-oncology Bavencio (ingredient: avelumab) has won additional approval from the Korean regulator as the first-line maintenance therapy for locally advanced or metastatic urothelial cancer.
The Ministry of Food and Drug Safety has expanded the drug’s indications based on a phase 3 trial called the JAVELIN Bladder 100, which compared the best supportive care (BSC) group and Bavencio with supportive care combined group. It is a primary maintenance therapy targeting locally advanced or metastatic urothelial cancer patients who had not progressed with first-line platinum-based chemotherapy.
The latter's median of overall survival (OS) was 21.4 months, 50 percent longer than the former’s 14.3 months, and the fatality risk also decreased by 31 percent. Besides, one of the important indexes of immune-oncology, the overall survival at one year was 58.4 percent in the control group compared with 71.3 percent in the Bavencio with the supportive care group.
Through JAVELIN Bladder 100 trial, Bavencio won approval from the U.S. Food and Drug Administration and the European Commission as maintenance therapy for locally advanced or metastatic urothelial cancer patients who had not gone through disease progression after first-line platinum-based chemotherapy, the two companies said.
With the expanded indications, Bavencio has proven its efficacy for locally advanced and metastatic urothelial cancer patients and strengthen its basis as a new standard therapy, they added.
“In the past thirty years, platinum-based chemotherapy was used as the standard first-line therapy. But, unfortunately, there were few positive results among urothelial cancer patients,” said Javed Alam, the general manager of Merck Biopharma Korea. “We did our best to expand the efficacy of Bavencio as soon as possible to satisfy unmet needs of bladder cancer.”
Song Chan-woo, head of the oncology business at Pfizer Pharma Korea, also said, “In JAVELIN Bladder trial, Bavencio strengthened the benefit of primary chemotherapy to another level and proved that the survival of locally advanced or metastatic urothelial cancer patients could be prolonged.”
The company hopes that Bavencio, a hopeful treatment for rare cancers like metastatic Merkel cell carcinoma, will now strengthen its footholds as an innovative treatment for bladder cancer.”
Merck and Pfizer Bavenci co-developed and commercialized Bavencio through a strategic partnership, combining their strength and capabilities in developing chemotherapy treatment.