Metastatic disease responds to enfortumab vedotin

CHICAGO – A new agent that acts as a smart bomb against urothelial cancers appears to get responses from patients who have been heavily pretreated, researchers reported here at the 55th annual meeting of the American Society of Clinical Oncology.

In describing results of treatment with enfortumab vedotin, Daniel Petrylak, MD, professor of medicine and urology at the Yale Cancer Center, New Haven, Connecticut, said that 12% of patients treated with the agent achieved a complete response and 32% of the 125 patients in the study achieved a RECIST-confirmed partial response.

“This drug directly delivers the chemotherapy to the cancer cell,” Petrylak said. “We demonstrated that 44% of patients had a response to treatment. That includes 38% of patients who had metastases to the liver responded as well. This was a very well tolerated treatment with a low rate of discontinuation.”

He said that median overall survival of the patients in the study is 11.7 months, despite having gone through chemotherapy and checkpoint inhibitor therapy without success, Petrylak said at a press conference.

“We have Phase 3 trials comparing enfortumab vedotin with standard chemotherapy in urothelial cancer and we are also combining it with checkpoint inhibitors,” Petrylak said. He said that, because the target of enfortumab vedotin is Nectin-4 — which is preferentially found on solid tumors — there is the opportunity to use the drug in other cancers.

“There are trials now being planned to look at lung cancer, head and neck cancer, and in gastric cancer,” he said. “There are also trials being designed right now to use this agent in breast cancer.”

In commenting on the study, Robert Dreicer, MD, an ASCO expert and deputy director of the University of Virginia Cancer Center, Charlottesville, said, “Urothelial cancer is a very common disease and there has been very limited therapeutics for treatment for it for decades. The median overall survival approaches a year and the best front-line treatment we have gives patients a median survival of 13 months. I would look at this data as being effective and ready for approval. I would support accelerated approval for this agent, and I hope the FDA shares that opinion.”

The trial enrolled 70 men and 45 women, and their median age was 69 years, including 34 persons who were at least 75 years old. The median number of previous systemic treatments was 3.

“The common adverse events we saw was neuropathy, diabetes, rash, and fatigue,” he said. “But we can manage these adverse events.”



The study was funded by Seattle Genetics and Astellas Pharma.

Petrylak disclosed relevant relationships with Bayer, Bellicum Pharmaceuticals, Dendreon, Johnson & Johnson, Exelixis, Ferring, Millennium, Medivation, Pfizer, Roche, sanofi, Tyme, Astellas Pharma, AstraZeneca, Lilly, Celgene, Progenics, Endocyte, Genentech, Merck, Novartis, Agensys, Innocrin Pharma, MedImmune, Soti, Seattle Genetics and Clovis Oncology.

Dreicer disclosed relevant relationships with Astellas Pharma, AstraZeneca, Eisai, EMD Serono, Genentech/Roche, Incyte, Janssen Oncology, Pfizer, BioClin Therapeutics, Merck, and Seattle Genetics.



Petrylak D, et al “EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors,” ASCO 2019; Abstract LBA4505.


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