Pfizer (PFE) and Astellas Pharma said additional follow-up results from a phase 3 clinical trial of Padcev plus Keytruda in first-line treatment of locally advanced or metastatic urothelial cancer showed a sustained overall survival and progression-free survival benefit.
The results were consistent with the findings of a primary analysis following an additional 12 months of follow-up, the companies said Monday in a statement.
The combination therapy lowered the risk of death by 49%, compared with chemotherapy, while the median overall survival was 33.8 months for the combination versus 15.9 months for chemotherapy.
The latest results of the trial "show a durable benefit," Ahsan Arozullah, head of oncology development at Astellas, said in the statement. The findings show "the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care," said Thomas Powles, Barts Cancer Center director in London and the study's primary investigator.
The data will be presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium 2025 in San Francisco on Friday.
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