'Astellas’ Padcev sets new standard in metastatic urothelial carcinoma care'

Astellas Korea highlighted the clinical impact of its antibody-drug conjugate (ADC) Padcev (ingredient: enfortumab vedotin) in metastatic urothelial carcinoma at a press conference in Seoul on Monday, underscoring how the therapy has redefined first-line standards through its combination use with pembrolizumab and delivered unprecedented survival benefits in a disease long lacking treatment innovation.

At the event, Professor Cho Jung-min of the Department of Oncology at Ewha Womans University Mokdong Hospital and Kang Yeh-rim, Head of Medical Affairs at Astellas Korea, discussed how Padcev has transformed treatment strategies in a cancer type long left with limited options.

Urothelial carcinoma, which accounts for the majority of bladder, renal pelvis, and ureter cancers, is characterized by rapid progression and aggressive features. For more than 30 years, platinum-based chemotherapy had remained the only standard of care for first-line treatment, leaving patients with few alternatives.

Padcev, the first ADC approved for metastatic urothelial carcinoma in Korea, received regulatory clearance in March 2023 and was launched in August of the same year. Its indication was expanded in July 2024 to include first-line use in combination with pembrolizumab, establishing a new standard paradigm in metastatic urothelial carcinoma care.

Kang emphasized that Padcev’s arrival marked a decisive turning point.

“As the first ADC for metastatic urothelial carcinoma, Padcev reduced the risk of death by about 53 percent in the first-line setting compared to existing treatment options,” Kang said. “With nearly one in three patients achieving complete response, the data received a standing ovation at the ESMO Presidential Session in 2023.”

The drug continues to reinforce its clinical evidence base through long-term follow-up studies, Kang added.

Updated results from the EV-302 trial presented at ASCO GU 2025 showed that Padcev in combination therapy more than doubled overall survival, reducing the risk of disease progression or death by 52 percent.

The objective response rate was 67.5 percent compared to 44.2 percent in the control group, while safety remained manageable.

Professor Cho underscored the urgent unmet need in this cancer type.

“Metastatic urothelial carcinoma has a survival rate of only 14.3 percent, with outcomes as poor as those seen in lung cancer,” she said. “Because the disease progresses aggressively and patients are often elderly, many deteriorate rapidly at early stages of treatment.”

She noted that Padcev’s efficacy is being confirmed in real-world practice, offering a meaningful option for strong initial responses.

However, Cho expressed concern over limited access.

“Even when effective treatments are available, the high cost makes it difficult to recommend them easily. It is frustrating for physicians when patients cannot receive optimal care on time,” Cho said. “Since major global guidelines, including NCCN, ESMO, and EAU, recommend Padcev as the preferred first-line option, institutional support in Korea is urgently needed to ensure patients do not miss treatment opportunities.”

Astellas Korea CEO Kim Jun-il added, “Padcev has provided patients long deprived of treatment options with a clear survival opportunity from the first line of therapy, bringing real hope to both physicians and patients.”

Astellas Korea will continue working to improve access so that more patients can benefit without delay, Kim said.