A new targeted treatment for urothelial cancer, which commonly occurs in elderly patients, is entering domestic prescription rights. The first antibody drug to target locally advanced or metastatic urothelial cancer, ‘Padcep’ (ingredient name: enfotumab vedotin), is the main character.
Urethral carcinoma is the most common type of bladder cancer, accounting for about 91% of all bladder cancers, and 8 out of 10 patients are aged 60 or older. However, existing treatment options, such as chemotherapy, which are highly toxic to patients, are limited, so there is a great unmet demand from both patients and medical staff.
Professor Miso Kim of the Department of Oncology at Seoul National University Hospital said, “Urothelial carcinoma is a fatal disease with frequent recurrence and metastasis, and the 5-year survival rate of metastatic bladder cancer is only about 5%.” It will present a new treatment paradigm with a drug that can be used for a single patient.”
Professor Kim, who attended the Padsep press conference of Astellas Pharmaceutical Korea held at InterContinental Seoul COEX on the 19th, expressed this expert opinion.
Professor Kim said, “Even though the quality of life of patients is significantly low due to symptoms of dysuria such as hematuria, urinary frequency, and residual urine, treatment has been difficult due to very limited treatment options. In particular, metastatic urothelial cancer has a low survival rate and Although the quality of life is significantly reduced, there are no appropriate treatment options for patients whose cancer has progressed or relapsed even after administration of immuno-oncology and platinum-based chemotherapy.”
He added, “Urothelial carcinoma progresses rapidly, so treatment must be continued. In the past, there was no standard treatment, so I had no choice but to use chemotherapy drugs after the second treatment using immuno-anticancer drugs.”
Professor Kim said, “Padcep is a treatment that can be used for patients whose cancer has progressed or recurred after chemotherapy (first-line treatment) and immunotherapy (second-line or first-line maintenance therapy).” “Locally advanced or metastatic urinary tract We expect to make a great contribution to improving the results of epithelial cancer treatment.”
Padcep is being evaluated as an antibody-drug conjugate (ADC) targeting Nectin-4. Based on the mechanism of action and clinical benefit, it is listed as a first-recommended drug in major cancer treatment guidelines. In March, it was approved as a monotherapy by the Ministry of Food and Drug Safety, and was first recommended as a ‘Category 1’ drug, which is a strong recommendation level in the NCCN guidelines.
In this regard, as a result of the 2-year follow-up of the EV-301 study, the main clinical trial of Padcep, the therapeutic benefits were remarkable. As a result of comparative evaluation of Padcep and conventional chemotherapy in 608 patients who had previously been treated with platinum-based chemotherapy and PD-1/L1 inhibitor (immunotherapy), the Fadcep group was compared to chemotherapy. It reduced the risk of death by about 30%.
In addition, the median overall survival (OS) of the Padcep group was 12.9 months, which was 3.97 months longer than the chemotherapy group, significantly improving the survival period. The median value of progression-free survival (PFS), a criterion for determining the effectiveness of anticancer drugs, was 5.6 months for the Padcep group and 3.7 months for the control group, showing a 37% reduction in the risk of disease progression.
Park Kyung-ah, director of the Medical Department of Astellas Pharmaceuticals Korea, said, “Padcep can start treatment without conducting a separate test to select a target for treatment in advance, significantly improving the quality of life and contributing to life extension for more urinary tract cancer patients. I hope there will be,” he said.
Kim Joon-il, CEO of Astellas Pharmaceuticals Korea, said, “I know that not only medical staff but also patients and guardians have been waiting for the introduction of Padcep in Korea, and we are happy to be able to release it as soon as possible.” We will do our best to provide it.”
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