Astellas Pharma and Seagen have reported new data from EV-201 and EV-103 clinical trials of Padcev (enfortumab vedotin-ejfv) which showed durable responses in locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin chemotherapy.
In the EV-201 trial, the second cohort included subjects who received previous immunotherapy but not platinum-containing chemotherapy. These participants were given Padcev alone.
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According to the data, 51% of the subjects who were given Padcev showed a confirmed objective response with a 16-month median follow-up, the trial’s primary endpoint.
A further 22% of subjects had a complete response and the median duration of response was 13.8 months.
Furthermore, the subjects survived a median of 6.7 months without disease progression (progression-free survival) and showed a median overall survival of 16.1 months.
Astellas senior vice-president and oncology therapeutic area head Andrew Krivoshik said: “EV-201 Cohort 2 is the first study to report objective responses in patients with advanced urothelial cancer that progressed following immunotherapy and who have medical conditions that prevent them from receiving cisplatin chemotherapy.”
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By GlobalDataIn the EV-103 trial, subjects in the dose-escalation cohort and expansion Cohort A received Padcev in combination with Merck’s (MSD) anti-PD-1 therapy Keytruda (pembrolizumab) as a first-line medication.
The longer-term analysis data showed a safety profile that is in line with the previously reported results, with a 24.9-month median follow-up, and no new safety signals were noted.
Seagen chief medical officer Roger Dansey said: “EV-103 is the first clinical trial to combine the antibody-drug conjugate Padcev with Merck’s anti-PD-1 therapy Keytruda in patients newly diagnosed with locally advanced or metastatic urothelial cancer.
“The updated data from EV-103 Cohort A, with two years of follow-up, build upon findings from the initial analysis, showing continued durability for this platinum-free combination.”
In February this year, Astellas reported positive top-line results from the Phase III pivotal SKYLIGHT 1 and SKYLIGHT 2 trials of an oral non-hormonal compound, fezolinetant, for treating moderate to severe vasomotor symptoms.
