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ESMO 2019: Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

By: Sarah Campen, PharmD
Posted: Monday, October 14, 2019

The first-line treatment with enfortumab vedotin and pembrolizumab led to an objective response in more than 70% of patients with cisplatin-ineligible locally advanced or metastatic urothelial cancer, according to a study presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona (Abstract 901O). Enfortumab vedotin is an investigational antibody-drug conjugate that targets Nectin-4, a protein that is highly and uniformly expressed by urothelial cancer. Christopher J. Hoimes, DO, of Case Western Reserve University, Cleveland, and colleagues stated that their dose-escalation/expansion study demonstrated “encouraging efficacy with a tolerable and manageable safety profile.”

The phase I study enrolled 45 patients with locally advanced or metastatic urothelial cancer who were not eligible for cisplatin therapy. They were treated with enfortumab vedotin on days 1 and 8 of 3-week cycles and pembrolizumab on day 1 of each cycle. The primary tumor location was in the lower tract in 69% (n = 31); 4 patients had locally advanced disease, and the remaining 41 had visceral disease, including liver metastases in 15 patients.

The combination therapy led to objective responses in 32 patients (71%), including complete responses in 6 (13%). Stable disease was the best result in 10 additional patients (22%), leading to a clinical benefit rate of 93%. All but three evaluable patients had some degree of tumor shrinkage.

As for safety, the most common treatment-related adverse events included fatigue (49%), alopecia (47%), peripheral sensory neuropathy (47%), diarrhea (40%), decreased appetite (33%), dysgeusia (31%), and rash (27%). The most common grade ≥ 3 adverse events were increased lipase (13%), fatigue (9%), and maculopapular rash (7%). Treatment-related adverse events of special interest for enfortumab vedotin—peripheral neuropathy, rash, and nonfasting hyperglycemia—occurred at rates similar to those observed in monotherapy studies.

Disclosure: The study authors’ disclosure information can be found at esmo.org.



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