Merck Biopharma Korea said it held a medical symposium titled “Thanks to Bavencio!” last Friday to celebrate the first anniversary of insurance coverage for its urothelial cell carcinoma treatment Bavencio (avelumab) in Korea.

The symposium shared the clinical benefits of Bavencio, which has set a new paradigm for treating urothelial cell carcinoma as first-line maintenance therapy for locally advanced or metastatic urothelial cell carcinoma.

Chaired by Professor Jeong Byong-chang of the Department of Urology at Samsung Medical Center, two sessions were held with the themes of “Evolution of Treatment Landscape in UC and “Treatment Paradigm Shift in the Maintenance Therapy in Metastatic Bladder Cancer: Standard of Care with Avelumab.”

"In the treatment of urothelial cell carcinoma, platinum-based chemotherapy has been the standard of care for the past 30 years. However, the low rate of second-line progression has resulted in a high unmet need for treatment after first-line chemotherapy," said Professor Ham Won-shik of the Department of Urology at Severance Hospital. "Recently, various treatment options for urothelial cell carcinoma have emerged, but none of them have shown better long-term data than Bavencio."

In the second session, Professor Seo Ho-kyung, director of the Urologic Clinic at the National Cancer Center, said, "Demonstrating a median overall survival (OS) of 30 months upon its introduction, Bavencio has become the standard of care for first-line maintenance therapy, with recent real-world data (RWD) showing even longer survival potential. Bavencio is valuable as it offers hope for 'long-term survival' to patients who would otherwise have to live with great anxiety about recurrence during the dormant period after first-line chemotherapy."

In the licensed clinical trial JAVELIN Bladder 100 (JB 100), which included patients with locally advanced or metastatic urothelial cell carcinoma whose disease had not progressed on platinum-based chemotherapy, Bavencio demonstrated a median overall survival (mOS) of 29.7 months (95 percent CI, 25.2-34.0) in a long-term follow-up of more than 38 months. This was more than nine months longer than the mOS of 20.5 months (95 percent CI, 19.0-23.5) in the control group receiving optimal supportive care alone after first-line platinum-based chemotherapy, and the clinical benefit was consistent regardless of the type and response to first-line chemotherapy and PD-L1 expression.

Real-world studies confirmed significant overall survival improvements. In the recently published prospective and retrospective real-world study AVENANCE, a subset analysis of 330 patients who received second-line treatment, those who received second-line treatment with an ADC after first-line maintenance with Bavencio had a median overall mOS of 40.8 months (95 percent CI, 32.6-42.1) from the start of first-line platinum-based chemotherapy.

Real-world data from Korean patients also confirmed the clinical validity of Bavencio. In the Expanded Access Program (EAP), which was conducted from Sept. 2, 2021, to June 16, 2023, in 30 patients, the median progression-free survival (mPFS) was 7.9 months (95 percent CI, 4.3-13.1), longer than the 5.5 months reported in the long-term follow-up study of JB 100.

"Because of its excellent profile in terms of both clinical efficacy and safety, Bavencio is recommended by global guidelines as first-line maintenance therapy for locally advanced or metastatic urothelial cell carcinoma, and is recommended as Category 1 in the NCCN guidelines," said Professor Jeong at Samsung Medical Center who moderated the symposium. "It is currently the only reimbursed option for first-line maintenance therapy for urothelial cell carcinoma in Korea, and has become the standard of care in clinical practice within one year."

Merck Biopharma Korea is supplying Bavencio for urothelial cell carcinoma in Korea. Based on the JAVELIN Bladder 100 study, Bavencio received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration in April 2020 and was approved by the FDA in June of that year for the first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed on platinum-based chemotherapy, becoming the new standard of care.

In Korea, it won approval from the Ministry of Food and Drug Safety in August 2021 for the same indication. Since August 2023, it has been covered by health insurance as first-line maintenance in adult patients with locally advanced or metastatic urothelial cell carcinoma whose disease has not progressed on platinum-based chemotherapy.