European Commission approves Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced urothelial cancer (bladder cancer)
Astellas Pharma Inc. announced that the European Commission has granted Marketing Authorization for Padcev (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with Keytruda (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy
The approval is based on results from the Phase III EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.
Thomas Powles, Barts Cancer Institute Biomedical Research Centre, UK; "Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase III clinical trial program, with enfortumab vedotin in combination with pembrolizumab significantly extending overall survival and progression-free survival compared to platinum-containing chemotherapy. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting.
Bladder cancer is the fifth most commonly diagnosed cancer across the European region. Every year, more than 165,000 people are diagnosed with the disease and it claims the lives of over 50,000 people in the European Union (EU). Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor.
The Phase III EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). the median pfs of 12.5 months (95% ci: 10.4-16.6) with the combination compared to 6.3 months (95% ci: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (hr="0.45;" 95% ci: (0.38-0.54); p><0.00001). during the ev-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a pd-l1 inhibitor, which is reflective of current real world clinical practice. results were presented at the 2023 european society for medical oncology (esmo) congress and published in the new england journal of medicine.
See-"Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer"- Authors: Thomas Powles, M.D., Begoña P. Valderrama, M.D., Shilpa Gupta, M.D., Jens Bedke, M.D., Eiji Kikuchi, M.D., Ph.D., Jean Hoffman-Censits, M.D., Gopa Iyer, M.D., +17, for the EV-302 Trial Investigators. Published March 6, 2024. N Engl J Med 2024;390:875-888 DOI: 10.1056/NEJMoa2312117 VOL. 390 NO. 10/
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