ESMO 2019: Seattle Genetics to Present Initial Data from a Phase I Trial Results of Enfortumab Vedotin Plus Pembrolizumab in in Locally Advanced or Metastatic Urothelial Cancer

Featured Image: Annual Congress of ESMO 2018. Courtesy: © 2018 European Society for Medical Oncology. Used with permission.
Featured Image: Annual Congress of ESMO 2018. Courtesy: © 2018 European Society for Medical Oncology. Used with permission.

Less than a week before the start of the annual meeting of the European Society for Medical Oncology (ESMO), to be held September 27 – October 1, 2019 in Barcelona, Spain, Seattle Genetics confirms that data from a number of investigational programs will be presented at the upcoming meeting.

The presentations include the first available data from a phase I clinical study of enfortumab vedotin plus pembrolizumab (Keytruda®; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.) in Locally Advanced or Metastatic Urothelial Cancer.

“We look forward to [this] presentation featuring antibody-drug conjugate enfortumab vedotin in combination with the immune therapy pembrolizumab in patients with previously untreated advanced urothelial cancer,” said Roger Dansey, MD., Chief Medical Officer at Seattle Genetics.

Lonza
MabPlex
ADC Bio
 

Enfortumab vedotin is an investigational antibody-drug conjugate which includes an anti-Nectin-4 monoclonal antibody attached to the microtubule-disrupting agent monomethyl auristatin E (MMAE). The drug uses a using proprietary linker technology developed by Seattle Genetics.

Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.

Earlier this week the FDA accepted a Biologics License Application and Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/PD-L1 inhibitor and who have received a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

Enfortumab vedotin is being co-developed by Seattle Genetics and Astellas Pharma Inc.

Tisotumab vedotin
Seattle Generics also confirmed that, during the upcoming ESMO meeting, data will be presented from tisotumab vedotin, an antibody-drug concjugate being co-developed with Genmab.

This investigation drug includes Genmab’s human antibody that binds to Tissue Factor and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the microtubule disrupting agent monomethyl auristatin E (MMAE).

In cancer biology, Tissue Factor is a protein involved in tumor signaling and angiogenesis. The Tissue Factor antigen target is overexpressed in the vast majority of patients with cervical cancer and in many other solid tumors, including ovarian, lung, pancreatic, colorectal and head and neck. Based on its high expression on many solid tumors and its rapid internalization, Tissue Factor was selected as a target for an ADC approach.

Overview of Presentation

AbstractTitlePresenterSessionTime/DateLocation
901OEV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinomaChristopher J. Hoimes, Case Western Reserve University, Cleveland, OH, USAOral Presentation Proffered Paper Session – Genitourinary tumours, non-prostateSaturday, September 28, 8:30-10:00 a.m. CESTBarcelona Auditorium, Hall 2
360PSystemic therapy in 2nd-line metastatic triple negative breast cancer (mTNBC): a systematic literature review (SLR) and meta-analysis (MA) of efficacyPeter A. Kaufman, University of Vermont Cancer Center, Burlington, VT, USAPoster PresentationSunday, September 29, 12:00-1:00 p.m. CESTBarcelona Auditorium, Hall 4
921PQuality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): data from EV-201 cohort 1Bradley A. McGregor, Dana-Farber Cancer Institute, Boston, MA, USAPoster PresentationMonday, September 30, 12:00-1:00 p.m. CESTBarcelona Auditorium, Hall 4
1059TiPPhase 1/2 trial of tisotumab vedotin plus bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8)Ignace B. Vergote, Leuven Cancer Institute, Leuven, BelgiumPoster PresentationSunday, September 29, 12:00-1:00 p.m. CESTBarcelona Auditorium, Hall 4

 

Clinical trial
A Study of Enfortumab Vedotin Plus Pembrolizumab and/or Chemotherapy for Patients With Urothelial Bladder Cancer (EV-103) – NCT03288545