The European Commission (EC) has granted marketing authorisation for Astellas’ Padcev (enfortumab vedotin) plus Merck’s Keytruda (pembrolizumab) to treat a type of urothelial cancer.
Padcev is an antibody-drug conjugate (ADC) directed against Nectin-4, a protein found on the surface of cells and highly expressed in bladder cancer.
Keytruda is a PD-1 inhibitor approved to treat several cancer types, including melanoma, lung cancer, head and neck cancer, stomach cancer, and cervical cancer, among others.
Astellas and Pfizer have signed a clinical collaboration agreement with Merck to evaluate Padcev plus Keytruda in patients with previously untreated metastatic urothelial cancer.
The Padcev plus Keytruda regimen is indicated for adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.
The EC marketing authorisation is based on results from the EV-302, also known as KEYNOTE-A39, an ongoing, open-label, randomised, controlled Phase 3 clinical trial.
In the study, the drug combination nearly doubled median overall survival (OS) and extended progression-free survival (PFS) compared to platinum-containing chemotherapy.
Astellas senior vice president and oncology development head Ahsan Arozullah said: “We are delighted that the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer.
“This approval is a testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community.
“We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey.”
In a separate development, Astellas announced the dosing of the first patient with its investigational nonhormonal compound, fezolinetant, in Phase 3 HIGHLIGHT 1 clinical study.
HIGHLIGHT 1 is a randomised, placebo-controlled, double-blind, Phase 3 clinical study, designed to evaluate the efficacy and safety of fezolinetant in treating a type of breast cancer.
Fezolinetant is currently being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer, receiving adjuvant endocrine therapy.
The study is planned to enrol 540 participants, randomised 1:1 to receive either fezolinetant or placebo at up to 100 sites worldwide, treated for 52 weeks with a final evaluation at 55 weeks.
The four co-primary endpoints include changes in the frequency and severity of moderate to severe VMS from baseline to weeks four and 12.
Astellas vice president, biopharma development head Marci English said: “VMS can adversely affect the quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy.
“We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients.”
