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Enfortumab vedotin: Treatment of bladder cancer
Enfortumab vedotin: Treatment of bladder cancer. Enfortumab vedotin, a new drug for bladder cancer, was certified as a breakthrough therapy. Enfortumab vedotin is used to treat patients with locally advanced or metastatic urothelial cancer.
The US FDA has issued a breakthrough therapy designation for the antibody drug conjugate (ADC) enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer.
Urethral cancer is most common in the bladder (90%). According to statistics from the American Cancer Society, in 2017, approximately 79,000 people in the United States will be diagnosed with bladder cancer, and nearly 17,000 people will die from this disease. Patients diagnosed with metastatic disease have a poor prognosis, with a 5-year survival rate of 5%.
Enfortumab vedotin uses Seattle Genetics’ proprietary connection technology to connect the microtubule disrupting agent MMAE and anti-Nectin-4 monoclonal antibody. Enfortumab vedotin can target Nectin-4, a cell adhesion molecule expressed on a variety of solid tumors.
This breakthrough therapy designation is based on the interim results of a phase 1 clinical study, which uses enuteumab vedotin as a monotherapy for patients with metastatic urothelial cancer treated with a checkpoint inhibitor (CPI). The primary endpoint is tolerability. The secondary endpoint is based on the solid tumor efficacy evaluation standard version 1.1 (RECIST v1.1), and the anti-tumor activity is evaluated every 8 weeks. Enfortumab vedotin has been well tolerated and has shown encouraging anti-tumor activity in patients who have undergone previous treatment, including those who have failed CPI.
The overall response rate (ORR) of all evaluable patients (n = 60) was 40% (95% CI: 27.6-53.5), and the response rate of patients who had received CPI (n = 24) was 46% (95% CI: 25.6-67.2), 44% of patients with metastases to the liver (95% CI: 19.8-70.1) (n = 16).
At doses ≥ 1 mg/kg, 3 patients had complete remission. The average treatment time was 26 weeks (range: 5.1-64.6), the median duration of remission was 18 weeks (95% CI: 8.4-40.1), and the median progression-free survival was 17 weeks (95% CI: 15.1-23.3) . In addition, Enfortumab vedotin is also being studied in a phase 2 pivotal clinical trial EV-201 (NCT03219333), as a single therapy, and early clinical trial EV-103 (NCT03288545) combined with CPI therapy.
“The FDA breakthrough therapy designation emphasizes the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. In addition, it supports our rapid development plan for ADC, including key research on this patient population, “Seattle Genetics Senior Vice President of Clinical Development Dr. Robert Lechleider said: “Seattle Genetics is an emerging multi-product oncology company with the goal of improving the treatment outcomes for cancer patients.
Enfortumab vedotin is at the forefront of our late-stage clinical pipeline. We are working closely with our partners and the FDA to provide patients with this potential new therapy as soon as possible. “
“Enfortumab vedotin’s breakthrough therapy is identified as another advancement that we bring additional treatment options to patients,” said Steven Benner, Astellas Senior Vice President and Global Head of Oncology Development. “With the enfortumab vedotin Phase 2 trial and With the active development of CPI combination therapy trials, Astellas looks forward to expanding the development of enfeumab vedotin and other tumor pipelines to include the most difficult-to-treat cancers.”
We look forward to the smooth progress of the clinical trials of this ADC therapy and bring new therapies to cancer patients as soon as possible.
(source:chinanet, reference only)