Padcev can be prescribed at tertiary hospitals in KOR

New ADC for Urothelial Cancer

Completes landing in the ‘Big 5’ hospitals in Korea after passing DC review at SNUH

First targeted therapy option in the area… demonstrated efficacy through EV-301 study

Padcev, the first targeted treatment for metastatic urothelial cancer, can now be prescribed at tertiary hospitals in Korea.

 

According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin) has passed the review of drug committees (DCs) at all of the ‘Big 5’ tertiary hospitals in Korea - the Samsung Medical Center, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, Sinchon Severance Hospital, with the Seoul National University Hospital being the last.

 

Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4.

 

It is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines.

 

It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet.

 

The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy.

 

Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.

 

In the trial, Padcev reduced the risk of death by 30% compared to chemotherapy.

 

The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy group's 9.0 months.

 

In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in risk of disease progression or death.

 

The median progression-free survival (PFS) for Padcev was 5.6 months and 3.7 months for the control group.

 

Mi-so Kim, Professor of the Department of Oncology at Seoul National University Hospital, explained, “Urothelial cancer is the most common type of bladder cancer that accounts for around 91% of all bladder cancers.

 

8 of 10 patients are over the age of 60, and due to its prevalence in the elderly and its frequent recurrence and metastasis, it is a fatal disease with a 5-year survival rate of around 5%.

 

It had been considered one of those representative diseases with a large unmet need due to its limited treatment options and the low quality of life caused by accompanying urinary disorder symptoms such as hematuria, frequent urination, and residual urine." Kim added, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later-line therapies after using immunotherapy in the second-line due to the lack of a standard later-line treatment option.

 

Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and therefore may open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”