Merck Biopharma's Bavencio changes urothelial carcinoma treatment paradigm in Korea

Merck Biopharma's immunotherapy Bavencio (ingredient: avelumab) has successfully established itself in the Korean clinical landscape, demonstrating significant improvements in overall survival (OS) for patients with advanced urothelial carcinoma.

During a press conference celebrating the drug's one-year reimbursement, Professor Kim In-ho of the Department of Oncology at Seoul St. Mary's Hospital shared insights into the current treatment landscape for advanced urothelial carcinoma and highlighted the clinical significance of Bavencio's insurance coverage.

"Historically, the standard first-line treatment for advanced and metastatic urothelial carcinoma has been platinum-based chemotherapy, which, despite achieving high response rates of 75-85 percent, has been associated with rapid disease recurrence and a significant unmet clinical need," Kim said. "Many patients experience severe toxicity after three to four months of chemotherapy, necessitating treatment breaks."

Consequently, the median overall survival (OS) for these patients typically ranged from just 12 to 15 months, Kim added.

In this context, Kim stressed that Bavencio has emerged as a game-changer with its robust clinical evidence.

In the JAVELIN Bladder 100 trial, which followed patients for over 38 months, Bavencio demonstrated a median OS of 29.7 months in patients with locally advanced or metastatic urothelial carcinoma who had not experienced disease progression following platinum-based chemotherapy.

This result represented a more than nine-month extension compared to the 20.5-month median OS observed in the control group.

Notably, Bavencio's clinical benefits were consistent regardless of the type of initial chemotherapy, response to the treatment, or PD-L1 expression status.

Additionally, real-world data from Korea, collected between September 2021 and June 2023 under the Expanded Access Program (EAP), revealed a median progression-free survival (PFS) of 7.9 months, surpassing the 5.5 months reported in the long-term follow-up of the JAVELIN Bladder 100 study.

Professor Kim emphasized Bavencio's role in improving patient outcomes.

"Given Bavencio's effectiveness, there is no reason not to proceed with maintenance therapy if the patient responds to it," he said.

Kim also addressed the complementary nature of Bavencio when compared to newly approved combination therapies, such as antibody-drug-conjugate (ADC) Padcev (enfortumab vedotin) and Keytruda (pembrolizumab), which have recently expanded their indications for first-line treatment in urothelial carcinoma.

"Each drug has its strengths and weaknesses," Kim said. "There is no set guideline for choosing between these options, and I believe they are all good therapies."

With more clinical experience, clear guidelines will eventually be established,  he added. 

Merck Biopharma Korea General Manager Chris Hamann highlighted Bavencio's impact.

"Bavencio is the first treatment option to usher in the era of long-term survival in urothelial carcinoma, a field where treatment options have long been limited," he said.

"Merck Biopharma Korea remains committed to providing hope to patients through continued investment in cancer drug research and development, and we will continue to work towards improving the treatment environment in Korea."