Seattle Genetics and Astellas Pharma Begin Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitors in Urothelial Cancer.
M2 PHARMA-November 9, 2017-Seattle Genetics and Astellas Pharma Begin Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitors in Urothelial Cancer
(C)2017 M2 COMMUNICATIONS
- Bothell, Washington-based cancer treatment developer Seattle Genetics, Inc. (NASDAQ: SGEN) and Tokyo, Japan-based Astellas Pharma Inc. (TSX: 4503) have dosed the first patient in EV-103, a phase 1b clinical trial evaluating the safety and tolerability of enfortumab vedotin in combination with pembrolizumab or atezolizumab, two types of immune checkpoint inhibitor therapies, for first- or second-line treatment of patients with locally advanced or metastatic urothelial cancer, the companies said.
Astellas and Seattle Genetics are co-developing, and have options to globally co-commercialize, enfortumab vedotin.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics' proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.
The EV-103 study is a single arm, open label multicenter trial that will enroll up to 85 patients with locally advanced or metastatic urothelial cancer who are ineligible for first line cisplatin-based chemotherapy or have progressed following treatment with a regimen containing platinum-based chemotherapy.
The primary objective of the trial is to assess the safety and tolerability of enfortumab vedotin in combination with CPI therapy. Secondary endpoints include the recommended dose in combination with CPIs, overall response rate, duration of response, progression-free survival, and overall survival, among other measures.
Enfortumab vedotin is also being studied as monotherapy in EV-201, a pivotal clinical trial for patients with advanced urothelial cancer who have received prior CPI therapy.
Astellas Pharma is dedicated to providing innovative and reliable pharmaceutical products. Prioritized therapeutic areas are urology, oncology, immunology, nephrology and neuroscience.
Seattle Genetics develops and commercializes novel antibody-based therapies for the treatment of cancer. The company's ADC technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.
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|Date:||Nov 9, 2017|
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