UC new drug!

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced the results of the Phase 1b/2 NORSE study (NCT03473743) at the 2021 European Society of Medical Oncology (ESMO) virtual conference

Preliminary research results show that the Balversa+cetrelimab regimen has shown strong clinical activity and depth of relief in patients, and its overall safety is generally consistent with Balversa monotherapy, and is comparable to the known safety profile of approved anti-PD-1 therapies.

At the time of data analysis, among the 19 patients who received Balversa+cetrelimab treatment, the objective response rate (ORR) assessed by the research investigator was 68% (95% CI: 43-87), of which 21% (n=4) were complete Remission (CR), 47% were partial remission (PR)

In this study, the safety of Balversa combined with cetrelimab (n=24) is basically similar to that of Balversa monotherapy (n=24).

Molecular structure of erdafitinib (picture source: medchemexpress.

Fibroblast growth factor receptors (FGFR) are a family of receptor tyrosine kinases that can be activated by genetic changes in many types of tumors, which may lead to increased tumor cell growth and survival rates

Balversa is a once-daily FGFR kinase inhibitor, approved in April 2019: it is used in adult patients with locally advanced or metastatic urothelial cancer (mUC) with specific FGFR gene changes

It is worth mentioning that Balversa is the first FGFR kinase inhibitor approved by the US FDA

Balversa is specifically approved for the treatment of mUC patients with FGFR3 or FGFR2 gene alterations in their tumors

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Original source: 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