Treatment with enfortumab vedotin, an antibody-drug conjugate, elicited responses in 44% of patients with locally advanced or metastatic urothelial cancer who had failed other treatments, according to the results of a single-arm, phase 2 clinical trial. The data were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.1
The study involved 125 patients with locally advanced or metastatic urothelial cancer who had previously been treated with platinum-based chemotherapy and/or checkpoint inhibitors. Of all the patients, 70% were male and the median age was 69. Moreover, 35% of the study participants had cancers in their upper urinary tract. The patients had previously undergone a median of 2 systemic therapies.
The participants received 1.25 mg/kg enfortumab vedotin on days 1, 8, and 15 of each 28-day cycle. The study’s primary end point was objective response rate. Some of the study’s secondary end points were overall survival and safety profile.
The investigators found that the objective response rate was 44% and complete response rate was 12%. Median overall survival was 11.7 months.
Among the most common adverse events were fatigue (seen in 50% of patients), alopecia (48% of patients), and decreased appetite (41% of patients). Treatment-related adverse events included rash and peripheral neuropathy.
The authors reported 1 death as treatment related, due to interstitial lung disease, but that link was confounded by a suspected pulmonary infection.
“In conclusion, there is a high unmet medical need for patients with metastatic and advanced urothelial carcinoma,” said lead study author Daniel Peter Petrylak, MD, a professor of medicine and urology at Yale School of Medicine in New Haven, Connecticut. “Enfortumab vedotin is the first novel therapeutic agent to demonstrate substantial clinical activity in patients who progressed after platinum chemotherapy as well as a PD-1/L1 inhibitor.”
“These data justify and support the submission to the FDA of enfortumab vedotin for accelerated approval,” Dr Petrylak said.
- Petrylak DP, Balar AV, O’Donnell PH, et al. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors. Presented at 2019 ASCO Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract LBA4505.
This article originally appeared on Cancer Therapy Advisor