Astellas launches urothelial cancer drug Padcev

"Promoting patient support"

Reduces the risk of death by 30% and the risk of disease progression by 37% compared to chemotherapy

Astellas officially launched 'Padcev' in Korea as a drug to treat locally advanced or metastatic urothelial cancer.

 

Astellas Pharmaceutical Korea held a press conference to commemorate the launch of Padcev in Korea at the Intercontinental Hotel in Seoul on the 19th.

 

Urethral carcinoma is a type of bladder cancer.

 

It is estimated that 90% of bladder cancers are urothelial carcinomas.

 

The survival prognosis is not known to be good.

 

Non-muscle invasive bladder cancer that does not invade the bladder muscle has a 5-year relative survival rate of 80%.

 

However, if the cancer invades the bladder muscle, the 5-year relative survival rate drops sharply to 50%.

 

In particular, about half of them lead to distant metastasis.

 

At this time, the 5-year relative survival rate is further reduced to 5%.

 

Patients receive platinum-based chemotherapy as first-line treatment and PD-1 or PD-L1 inhibitors as second-line treatment.

 

However, in the case of platinum-based chemotherapy, which is the first-line treatment, low tolerance and high possibility of disease progression were cited as problems.

 

Immunotherapy that can be considered as a second-line treatment showed that only 13-28% of patients responded to treatment regardless of PD-L1 status.

 

As a result, most of the disease progressed within 3 months of treatment.

 

Padcev is a treatment that can be used for patients whose cancer has progressed or relapsed after chemotherapy (first-line treatment) and immuno-anticancer drugs (second-line or first-line maintenance therapy) in situations where treatment options are not feasible.

 

Padcev is an antibody-drug conjugate (ADC) that targets nectin-4.

 

In March of this year, it was approved as monotherapy by the Ministry of Food and Drug Safety.

 

It is first recommended as Category 1 in the NCCN Guidelines.

 

The Padcev phase 3 trial was conducted by comparing and evaluating Padcev with existing chemotherapy drugs in 608 patients with locally advanced or metastatic urothelial cancer.

 

As a result, it was found that the Padcev administration group reduced the risk of death by about 30% compared to conventional chemotherapy.

 

The median overall survival (OS) of the Padcev-administered group was 12.9 months, which was 3.97 months longer than the chemotherapy group, demonstrating a significant improvement in survival time.

 

In addition, the median PFS of the Padcev-administered group was 5.6 months and that of the control group was 3.7 months, indicating a 37% reduction in the risk of disease progression.

 

Kim Mi-so, a professor of oncology at Seoul National University Hospital, said, "Platinum-based chemotherapy is mainly based on cisplatin.

 

However, the PFS ranges from 7.7 to 9.5 months, so most of the disease progresses within a year." Professor Mi-So Kim said, “Second-line PD-1/L1 inhibitors are recommended for patients whose disease has progressed after the first-line platinum-based chemotherapy, but most patients do not respond to treatment.” Park Kyung-ah, director of Astellas Pharmaceuticals Korea, said, "We will operate the patient program until Padcev is covered by reimbursement." Kim Joon-il, CEO of Astellas Pharmaceuticals Korea, said, “We are delighted to be able to release Padcev as early as possible.” "With Padcev, we will be able to provide innovative treatment options to patients with locally advanced or metastatic urothelial cancer in Korea," he said.