Bladder cancer drugs/new mechanisms appear one after another

Balversa, the first targeted anti-cancer drug, inhibits FGFR

ADC drug 'Padcev'

New treatment options for urothelial cancer are emerging one after another.

 

Domestic commercialization of new drugs such as targeted anticancer drugs and antibody-drug conjugates (ADCs) is underway.

 

Janssen's Balversa, which was approved at the end of last year, is suitable for patients with metastatic urinary tract disease with FGFR2 or 3 mutations who have progressed despite treatment with at least one chemotherapy agent or who have progressed within 12 months of adjuvant therapy before and after surgery including platinum-based chemotherapy.

 

It can be prescribed for patients with epithelial cancer (bladder cancer).

 

Bladder cancer is representative cancer for which there is no targeted anticancer drug.

 

Balversa has become the first targeted anti-cancer drug for bladder cancer with a new mechanism of FGFR (fibroblast growth factor receptor) inhibition.

 

FGFR is one of the biosignals involved in cancer cell growth and is associated with several carcinomas.

 

In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations.

 

Phase 2 BLC2001, which served as the basis for Balversa's approval, targeted 99 patients with locally advanced metastatic urothelial cancer with FGFR mutations.

 

The objective response rate of 87 evaluable patients was 32.2% based on the IRRC evaluation standard.

 

The disease control rate was 78%, and the median duration of response was 5.4 months.

 

mPFS and mOS were 5.5 months and 13.8 months, respectively.

 

Astellas Pharmaceuticals' ADC drug 'Padcep (Enfotumabvedotin)' obtained domestic approval on the 10th.

 

This drug can be prescribed for adult patients with locally advanced or metastatic urothelial cancer who have ▲PD-1 or PD-L1 inhibitors, ▲and platinum-based chemotherapy.

 

Padcev, which targets the Nectin-4 protein, which is frequently observed on the surface of urothelial cancer cells, binds to Nectin-4 expressed on the cell surface and moves into the cell, inhibiting cell division within the cell.

 

MMAE is released to induce apoptosis of cancer cells.

 

Padcev's approval was a global phase 3 clinical study comparing Padcev with conventional chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who had prior experience with platinum-based chemotherapy and PD-1/L1 inhibitor treatment.

 

This was done based on the results of EV-301.

 

As a result of the study, the Padcev-administered group reduced the risk of death by about 30% compared to conventional chemotherapy, and the mOS of the Padcev-administered group was 12.9 months, demonstrating a significant improvement in survival time compared to 9.0 months of chemotherapy.

 

Padcev's mPFS was 5.6 months versus 3.7 months for the control group, reducing the risk of disease progression by 38%.