The mix doubles the survival rate.
Results from a clinical trial reveal that a combination of two cancer medications significantly improves survival rates for individuals grappling with the most prevalent form of advanced bladder cancer.
The trial, detailed in the March 7 issue of the New England Journal of Medicine, showcased remarkable outcomes for patients administered a medication duo known as EV+P, comprising enfortumab vedotin and pembrolizumab (Keytruda). On average, patients receiving this combination therapy experienced a survival period of 31.5 months, more than doubling the 16-month survival observed in individuals treated with standard chemotherapy. Dr. Jean Hoffman-Censits, a co-investigator of the study, hailed these findings as revolutionary, emphasizing the transformative impact on patient care.
The study, conducted in collaboration with the Johns Hopkins Greenberg Bladder Cancer Institute, marks a significant advancement in the management of locally advanced and metastatic urothelial cancer, the most prevalent subtype of bladder cancer. Urothelial tumors afflict a substantial number of individuals annually, with over 83,000 new cases diagnosed in the United States alone, leading to nearly 17,000 deaths annually.
Funded by Astellas Pharma US, the trial enrolled 886 patients with advanced urothelial cancers across 25 countries. Notably, the participants, averaging 69 years of age, predominantly comprised men, reflecting the higher incidence of bladder cancer in this demographic.
Throughout the treatment period spanning 17 months, patients received either the EV+P regimen intravenously or standard chemotherapy consisting of gemcitabine and either cisplatin or carboplatin. The outcomes were striking, with the EV+P group demonstrating a near-doubling of progression-free survival, with an average of 12.5 months compared to 6.3 months for those receiving standard chemotherapy.
Furthermore, the EV+P regimen exhibited a favorable safety profile, with fewer incidences of severe side effects compared to traditional chemotherapy. Approximately 60% of individuals receiving the combination therapy reported side effects, contrasting with nearly 70% among those on standard chemotherapy.
Pembrolizumab, a well-established cancer therapy, combined with enfortumab vedotin, a newer medication granted FDA approval for urothelial cancers in December, offers a promising treatment approach. Enfortumab vedotin, functioning as an antibody-drug conjugate, targets and eradicates tumor cells by attaching an anticancer drug to a monoclonal antibody.
Dr. Hoffman-Censits underscored the broader therapeutic potential of this novel combination, particularly for patients ineligible for or intolerant to conventional chemotherapy. The study’s findings herald a significant breakthrough in the management of advanced bladder cancer, paving the way for enhanced treatment strategies and improved patient outcomes.
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