Zachary Bessette

GU Oncology Now

The phase 3 KEYNOTE-A39/EV-302 study has met its dual primary end points of overall survival (OS) and progression-free survival (PFS) in previously untreated, locally advanced or metastatic urothelial carcinoma (la/mUC), according to the latest <a href="https://www.prnewswire.com/news-releases/padcev-enfortumab-vedotin-ejfv-and-keytruda-pembrolizumab-significantly-improve-overall-survival-and-progression-free-survival-in-patients-with-previously-untreated-advanced-bladder-cancer-in-pivotal-phase-3-ev-302-trial-301935662.html" target="_blank" rel="noopener">topline results</a>.The trial assessed the combination of enfortumab vedotin-ejfv (EV) plus pembrolizumab versus chemotherapy (gemcitabine plus cisplatin or carboplatin). Investigators enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status.The combination demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy in patients with previously untreated la/mUC, researchers reported. Additionally, EV plus pembrolizumab showed a statistically significant improvement in overall response rate&mdash;the key secondary end point.The safety profile of EV plus pembrolizumab in this study was consistent with previously reported studies of this combination.&ldquo;The results of this pivotal phase 3 study are highly encouraging,&rdquo; said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer at Merck, in a <a href="https://www.investorsobserver.com/news/qm-pr/6288014654362550" target="_blank" rel="noopener">press release</a>. &ldquo;This is an important milestone, as many patients with advanced urothelial carcinoma still experience disease progression following chemotherapy.&rdquo;EV-302 is intended to serve as the confirmatory trial for the current US Food and Drug Administration accelerated approval of EV plus pembrolizumab as first-line treatment for patients with la/mUC who are not eligible to receive cisplatin-containing chemotherapy based on data from the EV-103 dose-escalation cohorts&mdash;Cohort A and Cohort K.

EV-302: EV Plus Pembrolizumab Improves OS, PFS in Untreated, Advanced Urothelial Carcinoma

Advanced Urothelial Carcinoma

The phase 3 KEYNOTE-A39/EV-302 study has met its dual primary end points of OS and PFS in previously untreated, advanced or metastatic urothelial carcinoma.

EV-302: Improving Survival in Untreated, Advanced UC

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