ASCO 2022 | 24-month findings from EV-301: enfortumab vedotin vs chemotherapy in previously treated advanced UC
Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center, New York City, NY, reports on the long-term outcomes of the Phase III, randomized, open-label, EV-301 (NCT03474107) trial evaluating enfortumab vedotin (EV) versus standard chemotherapy in patients with metastatic bladder cancer or upper tract urothelial cancer who had progressed on platinum therapy and checkpoint inhibitors. At the prespecified interim analysis, EV demonstrated superior overall-survival (OS) and progression-free survival (PFS) rates. Following an additional 12-month follow-up, at 23.75 months the median OS was significantly higher by 3.97 months compared to chemotherapy. PFS was additionally superior for EV treatment versus chemotherapy, with patients demonstrating a median of 5.55 months versus 3.71 months, respectively. Patients exhibited similar rated of treatment-related adverse events. Overall, EV continues to demonstrate benefit over standard chemotherapy in this patient population. This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.
Transcript (edited for clarity)
EV 30 was a randomized phase three trial of enfortumab vedotin or standard chemotherapy in patients with metastatic bladder cancer or upper track urothelial cancer, who had progressed on a prior platinum therapy, and also on checkpoint inhibitor.
So, the initial results showed a survival benefit for patients receiving in enfortumab vedotin was the interim analysis, and this represents the final analysis...
EV 30 was a randomized phase three trial of enfortumab vedotin or standard chemotherapy in patients with metastatic bladder cancer or upper track urothelial cancer, who had progressed on a prior platinum therapy, and also on checkpoint inhibitor.
So, the initial results showed a survival benefit for patients receiving in enfortumab vedotin was the interim analysis, and this represents the final analysis. I should say the interim analysis became the final analysis, and this is a long term analysis that was reported at ASCO 2022. So, we reported the 24 month follow up of patients on study and showed that there was a 10% increase in two year survival from just shy of 30% from enfortumab vedotin, compared to just under 20% for patients treated with standard of care chemotherapy. While that’s not a spectacular number in itself, we had not been thinking of 30% of patients being alive two years after third line therapy in the past, and really shows that there are patients who get significant benefit from enfortumab vedotin and the results confirm, essentially the interim, and final analysis, the toxicity profile hasn’t really changed since the initial report. There were a couple of extra cases of rashes, but most of the skin toxicity that occurs within enfortumab occurs early in the course of treatment.
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