Researchers from Memorial Sloan Kettering (MSK) Cancer Center shared data on a treatment option for patients with bladder cancer at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA73). Jonathan E. Rosenberg, MD, medical oncologist and Chief of the Genitourinary Oncology Service at MSK, presented results from the phase I/II trial (EV-103/KEYNOTE-869 Cohort K), which found that nearly two-thirds (64.5%) of previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who were treated with enfortumab vedotin-ejfv plus pembrolizumab saw their tumors shrink; 10.5% had their tumors disappear completely.
“The results of this cohort of the EV-103 trial are very promising for [patients with] bladder cancer,” said Dr. Rosenberg. “MSK has been on the forefront of developing and testing antibody-drug conjugates, such as enfortumab vedotin, either alone or in combination with checkpoint inhibitors, such as pembrolizumab, in bladder cancer. While immunotherapy has gotten more attention in recent years, antibody-drug conjugates might end up making a bigger positive impact in treating bladder cancer, especially in combination with checkpoint inhibitors, as shown in this trial.”
Jonathan E. Rosenberg, MD
In the phase Ib/II EV-103 clinical trial, patients treated with enfortumab vedotin and pembrolizumab (n = 76) had a 64.5% confirmed objective response rate (95% confidence interval [CI] = 52.7%–75.1%) per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review, the primary endpoint of Cohort K, with 10.5% of patients experiencing a complete response and 53.9% of patients experiencing a partial response. The median duration of response per blinded independent central review was not reached (95% CI = 10.25 months–not reached). Encouraging preliminary progression-free and overall survival results were observed, although these data remain immature at this time. Overall, the results were generally consistent with previously reported efficacy and safety results of the EV-103/KEYNOTE-869 dose-escalation cohort and expansion Cohort A.
The study authors concluded, “Enfortumab vedotin plus pembrolizumab showed high objective response rate with rapid responses and median duration response not reached in a first-line cisplatin-ineligible population. The safety profile was tolerable and generally consistent with the known profile for enfortumab vedotin and pembrolizumab. Enfortumab vedotin monotherapy was consistent with prior experience. These data support ongoing investigations of first-line enfortumab vedotin and pembrolizumab in patients with locally advanced or metastatic urothelial cancer who have a high unmet need.”
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.
