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ASCO conference: J&J's bladder cancer drug meets goal of phase 2 study

Johnson & Johnson said erdafitinib met its main goal in a phase 2 study of reducing tumor size among patients with a common form of bladder cancer.

The study involved 99 patients whose urothelial cancer, characterized by a mutation in the FGFR3 gene, had spread to other parts of the body and could not be surgically removed. The results were released at the American Society of Clinical Oncology meeting in Chicago.

Certain participants in the study had been previously treated with chemotherapy or immune checkpoint inhibitors, a class of medicines that includes Merck & Co. Inc.'s Keytruda and Bristol-Myers Squibb Co.'s Opdivo.

Immune checkpoint inhibitors block certain proteins made by immune cells as well as some cancer cells and can boost the immune system's ability to kill cancer cells.

Treatment with erdafitinib shrank the tumor by a pre-defined size, a measure known as overall response rate, among 40% of the patients, thus meeting the study's main goal.

The study also found that tumors disappeared in 3% of patients and partially shrank in 37% of those who received erdafitinib, with no worsening of cancer among an additional 39% of patients.

According to the preliminary data, the patients in the study survived an average of 13.8 months since the beginning of treatment with erdafitinib.

The New Brunswick, N.J.-based company added that of the 22 patients who had been treated with immune checkpoint inhibitors, erdafitinib reduced tumor size in 59% of the patients.

The study reported manageable treatment-related side effects, with 10% of patients discontinuing the treatment due to such symptoms.

Johnson & Johnson said erdafitinib may be able to perform better than immune checkpoint inhibitors in treating urothelial cancer with FGFR3 gene mutation.

The five approved checkpoint inhibitors have shown an overall response rate of 15% to 20%, Arlene Siefker-Radtke, study's principal investigator, said in a news release.

Erdafitinib blocks the activity of all FGFR proteins, including FGFR3, whose mutation is believed to drive the development of the disease.

The company is conducting a phase 3 study to compare the drug's effectiveness with chemotherapy or Merck's Keytruda in urothelial cancer with the FGFR3 mutation.

More than 81,000 cases of bladder cancer are expected to be diagnosed in the U.S. in 2018, with more than 17,000 deaths from the disease, Johnson & Johnson said, citing data from the American Cancer Society.

The U.S. Food and Drug Administration had previously granted erdafitinib the breakthrough therapy designation for its potential to treat urothelial cancer. The medicine was discovered as part of a partnership between Johnson & Johnson and Astex Pharmaceuticals Inc.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.