Enfortumab Vedotin-ejfv, Pembrolizumab Combination Shows Promise Treating Urothelial Cancer


Investigators reported that enfortumab vedotin-ejfv (Padcev; Astella Pharma Inc, Seagen Inc) in combination with pembrolizumab (Keytruda; Merck & Co Inc) met the dual primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic urothelial cancer.

Enfortumab vedotin-ejfv (Padcev; Astella Pharma Inc, Seagen Inc) in combination with pembrolizumab (Keytruda; Merck & Co Inc) produced positive results in patients with previously untreated, locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body, according to results from the phase 3 EV-302 (NCT04223856) trial.1

Therapy for Cancer Treatment Concept Cancer therapy with T-cell and pipette | Image Credit: catalin - stock.adobe.com

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“This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer. We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon as possible,” Roger Dansey MD, president of research and development at Seagen, said in a statement.1

The study included patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy, regardless of programmed cell death ligand 1 (PD-L1) status. The trial compared the combination to chemotherapy, with patients randomized to receive either regimen.1

Investigators reported that the study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy, determined by an independent data monitoring committee. The committee also said that the OS exceeded the pre-specified efficacy boundary for the interim analysis.1

Safety results were consistent with previous findings for enfortumab vedotin-ejfv in combination with pembrolizumab for the study population.1

The full details of the study will be presented at an upcoming scientific congress. The trial was intended as the basis for global submission, as well as the confirmatory trial, for the accelerated approval of the combination by the FDA.1

In April 2023, the FDA granted accelerated approval to the combination for adults with la/mUC who are not eligible for cisplatin-containing chemotherapy based on the results from the EV-103 trial (NCT03288545), making it the first approval for an anti-PD-1 therapy in combination with an antibody-drug conjugate in the United States for this population.1,2

This approval was based on tumor response rate and durability of response (DOR) results. In the dose escalation cohorts, A and K, the median follow-up time was 44.7 months and 14.8 months, respectively. In the combined analysis, the objective response rate was 68%, with complete and partial responses of 12% and 55%, respectively. The median DOR was 22.1 months in cohort A and not reached in cohort K.2

“We are thrilled that the topline results of the EV-302 study demonstrated that the combination of enfortumab vedotin and pembrolizumab improved the dual primary endpoints of OS and PFS. Patients living with metastatic urothelial cancer are in dire need of additional treatment options and this combination has the potential to advance the standard of care. We are extremely grateful to all of the patients who participated in this trial,” Ahsan Arozullah, MD, MPh, senior vice president and head of Oncology Development at Astellas, said in the statement.1

The trials were part of an extensive program used to evaluate the combination across multiple stages of UC.1


  1. 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. News release. Seagen. September 22, 2023. Accessed September 22, 2023. https://investor.seagen.com/press-releases/news-details/2023/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/default.aspx
  2. FDA grants accelerated approval to enfortumab vedotin-ejfv plus pembrolizumab for urothelial carcinoma. Pharmacy Times. April 4, 2023. Accessed September 22, 2023. https://www.pharmacytimes.com/view/fda-grants-accelerated-approval-to-enfortumab-vedotin-ejfv-plus-pembrolizumab-for-urothelial-carcinoma
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