Preliminary results from a phase 3 study recently established that the treatment combination of Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) improved survival outcomes for patients with urothelial cancer, a type of bladder cancer.
Urothelial cancer begins in the cells that line the bladder, urethra, ureters, renal pelvis and other organs, in which these types of cells are able to stretch and change shape without breaking, as defined by the National Cancer Institute.
Padcev is a type of monoclonal antibody that binds onto a protein called nectin-4 that is found on cancer cells and contains an anticancer drug, which helps to kill cancer cells. This drug is commonly used to treat patients with urothelial cancer and can be used alone or with Keytruda, according to National Cancer Institute.
Keytruda is a monoclonal antibody and checkpoint inhibitor, meaning it blocks a type of protein called PD-1, which helps the immune system kill cancer cells. This type of drug is used for many types of cancers and can be used alone or in combination with another cancer drug, the National Cancer Institute noted.
In April, the Food and Drug Administration approved the combination of Padcev and Keytruda to treat patients with locally advanced or metastatic urothelial cancer.
A press release from Astellas Pharma, the manufacturer of Padcev, announced that the combination of Padcev and Keytruda has improved survival in certain patients with urothelial cancer. Specifically, a phase 3 clinical trial, EV-302, is analyzing the combination of Padcev and Keytruda for patients with untreated, locally advanced or metastatic urothelial cancer as compared with patients who receive chemotherapy alone. The study randomly assigned the participants into two cohorts: Padcev plus Keytruda and chemotherapy alone.
The trial’s main focuses — known as primary endpoints — are overall survival (OS, the period from diagnosis or treatment where patients are still alive) and progression-free survival (PFS, the period during and after treatment when the disease does not worsen).
“We are thrilled that the topline results of the EV-302 study demonstrated that the combination of (Padcev) and (Keytruda) improved the dual primary endpoints of OS and PFS,” said Dr. Ahsan Arozullah, senior vice president and head of oncology development at Astellas, in the press release. “Patients living with metastatic urothelial cancer are in dire need of additional treatment options and this combination has the potential to advance the standard of care. We are extremely grateful to all of the patients who participated in this trial.”
During an early analysis within the study, it was also established that the OS surpassed the efficacy boundary, meaning the treatment combination showed better efficacy than the researchers had expected from the early analysis.
“This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Dr. Roger Dansey, president of research development at Seagen, said in the press release. “We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon as possible.”
“Over 200,000 deaths from urothelial cancer are reported worldwide annually, making it a major cause of morbidity and mortality,” said Dr. Thomas Powles, professor of genitourinary oncology at Queen Mary University of London, director of Barts Cancer Center in London and the primary investigator of the EV-302 trial, in the news release. “The topline results from EV-302 are encouraging for patients with advanced-stage urothelial cancer, which is aggressive and associated with devastating outcomes.”
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