Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA ® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor

September 17, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced results from the Phase 1b/2 NORSE (NCT03473743) study evaluating BALVERSA® (erdafitinib) in combination with cetrelimab, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody, compared to BALVERSA® monotherapy in patients with locally advanced or metastatic urothelial carcinoma (mUC) with fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations who are ineligible for cisplatin, a current standard of care treatment for mUC. The results were highlighted in an oral presentation at the European Society for Medical Oncology (ESMO) Annual Congress 2021 virtual meeting on Friday, September 17 (Abstract #LBA 27).1 Preliminary findings suggest robust clinical activity and depth of response in patients treated with BALVERSA® in combination with cetrelimab.1 The overall safety of treatment with BALVERSA® in combination with cetrelimab was generally consistent with BALVERSA® monotherapy and aligned with the known safety profile of approved anti–PD-1 therapies.1 At the time of analysis, the investigator-assessed objective response rate (ORR) in 19 patients treated with BALVERSA® in combination with cetrelimab was 68 percent (95 percent confidence interval [CI]; 43-87), of which 21 percent (n=4) were complete responses (CR) and 47 percent were partial responses (PR).1 The disease control rate (DCR) was 90 percent (9...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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