Merck Biopharma Korea and Pfizer Korea have stated that their joint immunotherapy Bavencio (ingredient: avelumab) has received approval for the treatment of urothelial carcinoma.
Bavencio, the first and only FDA-approved anti-PD-L1 immunotherapy, was first authorized to treat Merkel cell carcinoma in 2019 and received regulatory approval from the Department of Food and Pharmaceutical Safety on August 5 as the first-line treatment for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after the use of platinum-based chemotherapy.
The ministry approved the drug based on results presented in the phase 3 JAVELIN Bladder 100 trial comparing results between Best Supportive Care (BSC) and Babencio plus BSC.
During the study, the median overall survival period was prolonged by more than seven months in those who received Bavencio and BSC together compared to the comparison group receiving BSC care alone, with a risk of death reduced by 31%.
Bavencio is a medicine which induces natural killer (NK) cells to eliminate tumor cells by antibody-dependent cell cytotoxicity (ADCC).
Professor Lee Jae-lyun from the Oncology Department of Asan Medical Center presented the current trend of urothelial cancer therapy in Korea and the unmet medical needs.
Lee explained that urothelial carcinoma is the most common type of bladder cancer, accounting for about 90 percent of all cases. He pointed out that around 12% of patients have entered an advanced stage at the time of diagnosis and that the five-year survival rate remains around 6%.
“Patients treated with Bavencio maintained a median overall survival period of 7.1 months in the JAVELIN Bladder 100 study, showing a significant difference with a risk of death reduced by 31% compared to the control group,” said the Professor Lee.
Lee also pointed out that the one-year overall survival rate, one of the important endpoints in immunotherapy studies, was 58.4% in the control group, while the Bavencio group reached 71.3%. .
“In 2018, urothelial carcinoma became one of the most common cancers, ranking fourth in the world for frequency of diagnoses and 10th most common male cancers in Korea,” said Javed Alam, Managing Director by Merck Biopharma Korea. “We are pleased to provide a new treatment option for patients with urothelial carcinoma with unmet medical needs thanks to the recent approval. “
Song Chan-woo, Head of Oncology Business at Pfizer Pharma Korea, also said, “Bavencio has extended lifespan and reduced risk of death in patients with locally advanced or metastatic urothelial carcinoma during study, and we want the drug to provide new hope for patients with urothelial carcinoma.
Based on the JAVELIN Bladder 100 study, the United States Food and Drug Administration approved Bavencio in July 2020 as maintenance therapy in adult patients with locally advanced or metastatic urothelial carcinoma who do not have progressed after taking platinum-based chemotherapy. The European Commission also cleared the drug for the same indication in January.