The bladder cancer research tested the effectiveness of the drug, known generically as enfortumab vedotin-ejfv, alongside Keytruda and measured its effects against chemotherapy treatment.
Researchers found that the combination improved overall survival (OS) and progression-free survival (PFS) along with clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer.
The study, also known as EV-302 (NCT04223856), met its dual primary endpoints of OS and PFS, compared to platinum and gemcitabine chemotherapy.
Patients treated with a combination of Padcev and Keytruda were found to have a median overall survival of 31.5 months compared to a median of 16.1 months in patients who received chemotherapy. They also experienced a 55% reduction in the risk of cancer progression or death compared to treatment with chemotherapy.
Roger Dansey, president of research and development at Seagen, said: “The combination of enfortumab vedotin and pembrolizumab, if approved, represents a potential paradigm shift in the treatment of metastatic urothelial cancer.
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“The results of this historic trial presented today show improvements in overall survival and progression-free survival not previously achieved in a broad population of patients.”
In terms of secondary endpoints, the results showed a 68% confirmed objective response rate, against a rate of 44% in patients treated using chemotherapy.
The open-label randomised trial enrolled 886 patients with previously untreated locally advanced or metastatic urothelial cancer who were eligible for cisplatin or carboplatin-containing chemotherapy.
Ahsan Arozullah, senior vice president of Astellas added: “The presentation of this data is an important milestone for this patient population, and we look forward to continued discussions with regulatory authorities as we work to expedite bringing this therapy to those who need it most.”
GlobalData found that in 2022 the sales for Padcev at around $564m, with an expected rise to $2,920m by 2029.
GlobalData is the parent company of Clinical Trials Arena.