2:03 PM
May 16, 2018
 |  BC Extra  |  Clinical News

J&J highlights FGFR inhibitor data ahead of ASCO

Johnson & Johnson (NYSE:JNJ) unveiled for the first time data for its fibroblast growth factor receptor (FGFR) inhibitor, erdafitinib (JNJ-42756493). In the Phase II BLC2001 trial, erdafitinib led to a confirmed objective response rate (ORR) of 70% in 21 evaluable urothelial carcinoma patients who received prior immune checkpoint inhibitors.

The data were released late Wednesday in an abstract ahead of the American Society of Clinical Oncology meeting in Chicago.

The open-label, international trial is slated to enroll about 210 patients with metastatic or unresectable urothelial carcinoma and FGFR alterations who progressed during or following at least one line of prior chemotherapy.

In all 96 evaluable patients, erdafitinib led to a confirmed ORR of 42%, including three complete responses and 37 partial responses. The disease control rate (DCR) was 80%.

In March, J&J started a Phase III trial evaluating erdafitinib to treat patients with advanced urothelial cancer and FGFR alterations who progressed after one prior treatment. Erdafitinib has breakthrough therapy designation in the U.S. to treat urothelial cancer.

According to BioCentury's BCIQ database, the next most advanced FGFR inhibitor in development for urothelial carcinoma is INCB54828 from Incyte Corp. (NASDAQ:INCY), which is in Phase II testing.

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