The following is a summary of “Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer,” published in the January 2023 issue of Oncology by Hoimes, et al.


The gold standard of treatment for locally advanced or metastatic urothelial carcinoma (la/mUC) is cisplatin-based combination chemotherapy; nevertheless, toxicity was severe, responses were seldom long-lasting, and many la/mUC patients were ineligible. Enfortumab vedotin, pembrolizumab, and each of them demonstrated a survival advantage over chemotherapy in UC, were not constrained by cisplatin eligibility, and were therefore deserving of further study as a first-line (1L) combination treatment in patients ineligible for cisplatin.

Enfortumab vedotin 1.25 mg/kg once daily on days 1 and 8 and pembrolizumab 200 mg (day 1) intravenously once daily in three-week cycles were given to patients with la/mUC who were unable to receive 1L cisplatin in this ongoing phase Ib/II, multicenter, open-label research. Safety was the main objective. Key secondary endpoints included overall survival (OS), duration of response (DOR), and verified objective response rate.

Enfortumab vedotin and pembrolizumab were given to 45 individuals. Alopecia (48.9%), tiredness (51.1%), and peripheral sensory neuropathy (55.6%) were the most frequent treatment-related adverse events (TRAEs). The most prevalent TRAEs in 29 individuals (64.4%) were elevated lipase (17.8%), maculopapular rash (11.1%), and weariness (11.1%). About 2.2% of deaths were labeled as TRAEs, one of which. After a median of nine cycles, the verified objective response rate was 73.3%, and the full response rate was 15.6%. The median DOR and median OS were 25.6 and 26.1 months, respectively.

The safety profile for fortumab vedotin with pembrolizumab was tolerable. The majority of patients had shrinking tumors. The combination was being investigated in phase III research and showed promise, with the median DOR & median OS exceeding 2 years in a patient cohort ineligible for cisplatin.

Reference: ascopubs.org/doi/full/10.1200/JCO.22.01643