ASCO: Johnson & Johnson's Balversa tops chemotherapy in bladder cancer trial

Johnson & Johnson’s Balversa can keep some metastatic bladder cancer patients alive longer than chemotherapy, according to a study of 266 who have fibroblast growth factor receptor (FGFR) gene mutations and had already received checkpoint inhibitors.

In the phase 3 THOR trial, Balversa cut the risk of death by 36% to accomplish its primary objective. It helped extend lives by an average of 12.1 months versus a 7.8-month average for patients on chemotherapy.

The interim results were from cohort 1 of the confirmatory study and were presented Monday at the American Society of Clinical Oncology's (ASCO's) annual meeting in Chicago.

“The use of Balversa in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer,” Yohann Loriot, M.D., Ph.D., of the University of Paris-Saclay in France and the principal study investigator, said in a release.

Balversa was approved on an accelerated basis in 2019, becoming the first FGFR inhibitor on the market and prompting then-CEO Alex Gorsky to declare it a potential blockbuster. The daily, oral treatment also was the first approved for bladder cancer that was aimed at a specific genetic biomarker.

FGFR2 and FGFR3 mutations account for roughly 20% of metastatic urothelial carcinomas, which are the most common form of bladder cancer, according to J&J.

J&J did not release results from cohort 2 of the THOR trial, which tested Balversa versus Merck’s Keytruda in patients who have been treated but not with checkpoint inhibitors.

Also at ASCO, J&J also showed final results of the NORSE phase 2 trial that measured Balversa as a solo agent versus a combination of Balversa and J&J’s investigational checkpoint inhibitor cetrelimab as a first-line treatment for patients with metastatic urothelial carcinoma who were ineligible for chemotherapy and had FGFR mutations.

While Balversa alone shrunk tumors in 44.2% of patients, the combo had a 54.5% success rate. Median progression-free survival in the combo arm came in at 11 months versus 5.6 months for Balversa alone. The results were consistent with what J&J showed from the trial two years ago.