The European Union’s approval of Bristol Myers Squibb’s OPDIVO® marks the first consent of a simultaneous chemotherapy-immunotherapy combination for patients who have unresectable (inoperable) or metastatic urothelial carcinoma (UC).
In addition, the combination consists of the chemotherapy regimen gemcitabine and cisplatin to treat adult first-line UC patients.
About the CheckMate 901 Trial (NCT03036098)
The CheckMate 901Phase III trial showed that Opdivo, gemcitabine, cisplatin, and then subsequent Opdivo monotherapy brought about substantial improvements in both overall survival as well as progression-free survival. When comparing the combination to standard chemotherapy the results showed a 22% reduction in the risk of death and a 28% reduction in disease progression compared to the standard chemotherapy.
Dana Walker M.D., the V.P. and lead for the global program, thanked the patients, researchers, families and others involved with the trial. Dr. Walker discussed the importance of having a treatment option for these cancers.
In addition, Dr. Michiel Van der Heijden, a Netherlands Cancer Center group leader, suggested that the new option should be used as a standard for these difficult to treat cancers.
Results of the safety profiles were consistent with previously known profiles of each individual component with no new concerns identified. Several common AEs reported but not limited to were fatigue, decreased appetite, nausea and rash.
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bladder cancer news treatment urothelial carcinoma
Last modified: July 15, 2024
