In a groundbreaking advancement for patients with locally advanced or metastatic urothelial cancer, the FDA greenlit the combination treatment of Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab), marking a significant milestone in oncological care. The approval for urothelial cancer treatment, granted after thorough evaluation and with priority review and breakthrough designation, stems from the remarkable efficacy showcased in clinical trials.
The pivotal EV-302/KN-A39 trial, an open-label, randomized study, involved 886 patients without prior systemic therapy for advanced disease. The trial’s primary endpoints of progression-free survival (PFS) and overall survival (OS), assessed through a blinded independent central review, displayed substantial improvements when comparing the Padcev and Keytruda combination with platinum-based chemotherapy.
Positive Outcomes in Padcev/Keytruda Combo vs. Platinum-Based Chemotherapy for Urothelial Cancer
The combination treatment exhibited a substantial increase in median OS, stretching to 31.5 months compared to 16.1 months with platinum-based chemotherapy. Likewise, median PFS nearly doubled with the Padcev and Keytruda regimen, reaching 12.5 months in contrast to 6.3 months with standard chemotherapy.
Exploring the dose escalation cohorts A and K, the data showed promising results, with an impressive objective response rate (ORR) of 68%. Within this, complete responses accounted for 12%, and partial responses for 55%, showcasing the potency of this combined therapy in eliciting robust responses. The median duration of response (DOR) reached 22.1 months in cohort A and was not reached in cohort K, further indicating the sustained effectiveness of the treatment.
Adverse Effects in Padcev/Keytruda Combo
However, the treatment was not without adverse effects, with several common ones reported in over 20% of patients. These included various laboratory abnormalities, changes in liver enzymes and kidney function, skin-related issues like rash and pruritus, peripheral neuropathy, alterations in blood cell counts, fatigue, gastrointestinal disturbances such as diarrhea, and metabolic changes involving glucose and lipid levels. Additional observed adverse effects comprised hair loss, alterations in body weight and appetite, eye-related concerns, and urinary tract infections.
The FDA’s approval of the Padcev/Keytruda combination underscores a significant breakthrough in managing locally advanced or metastatic urothelial cancer, offering patients a promising therapeutic option demonstrating remarkable efficacy and manageable adverse effects in clinical trials.
Resource: Pharmexec, December 18, 2023
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