'Bavencio improved progression-free survival in Korean urothelial carcinoma patients'

Merck Biopharma Korea said on Monday that its urothelial carcinoma (UC) treatment, Bavencio (avelumab), demonstrated a progression-free survival (PFS) benefit in Korean patients with advanced or metastatic UC whose disease had not progressed on platinum-based chemotherapy.

The findings were obtained through the Expanded Access Program (EAP), also known as “compassionate use,” which allows the use of investigational new drug (IND) products outside of clinical trials. This program for Bavencio, conducted from September 2, 2021, to June 16, 2023, at five hospitals in Korea, involved 30 patients with locally advanced or metastatic UC whose disease had not progressed on platinum-based chemotherapy.

Analysis of the data showed a median PFS of 7.9 months after starting treatment with Bavencio, compared to the 5.5 months reported in the long-term follow-up of the JAVELIN Bladder 100 trial (JB 100), a global clinical study of Bavencio. Additionally, 20 percent of patients achieved a complete response (CR), with a median duration of CR of 17.8 months.

The findings were presented at the 2022 conference of the Korean Society of Medical Oncology (KSMO) and were published June 4, 2024 in the 14th issue of Frontiers in Oncology, an international journal of oncology. 

Bavencio demonstrated a median overall survival (mOS) of 29.7 months in a long-term follow-up of the JB 100 trial for patients with locally advanced or metastatic UC whose disease had not progressed on platinum-based chemotherapy.

In addition, a subset analysis of 330 second-line patients in AVENANCE, a  real-world study, showed that patients treated with antibody-drug conjugates (ADCs) after first-line maintenance with Bavencio had a median overall mOS of 40.8 months from the start of first-line platinum-based chemotherapy.  

Currently, global guidelines, including the U.S. National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), and European Association of Urology (EAU), recommend Bavnecio as first-line maintenance therapy for metastatic UC, with a category 1 recommendation from the NCCN, Merck Korea said.

"This is the first real-world data confirming the clinical effectiveness and safety of Bavencio in the Korean population, demonstrating that the clinical benefits seen in global clinical studies are consistent in Korean clinical practice," said Koh Min-jung, country medical director of Merck Biopharma Korea. "As the global standard of care (SoC) for locally advanced or metastatic UC, we will continue to strive to bring clinical benefit to more Korean patients."