Reduce the risk of bladder cancer death by 30% "first-in-class" ADC early termination of Phase 3 trials.

Seattle Genetics and Astellas recently announced that the antibody-coupled drug Padcev (enfortumab vedotin-ejfv), developed jointly, has reached the main end of its total lifetime in Phase 3 clinical trials for patients with localized advanced or metastatic urethroid skin cancer.
these patients have been treated with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.
based on this positive interim analysis, this clinical trial will be terminated early.
, about 580,000 people worldwide will be diagnosed with bladder cancer by 2020.
90 per cent of all bladder cancers, can also occur in the kidneys, ureter and urethra.
80% of patients with advanced stages would not respond to PD-1 or PD-L1 inhibitor therapy after failing initial chemotherapy with platinum.
Padcev is an antibody-coupled drug that couples anti-nectin-4 monoclonal antibodies with micro-tube inhibitors.
Nectin-4 protein is a highly expressed cell adhesion molecule in urethra skin cancer.
based on remission rate data, the therapy was approved by the FDA in December to treat patients with locally advanced or metastatic urethroid skin cancer.
these patients have been treated with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.
clinical trial, Padcev significantly improved the overall survival of patients compared to the chemotherapy control group, reducing the risk of death by 30 percent (HR=0.70,95% CI:0.56,0.89, p=0.001).
Padcev also significantly improved patients' progressed survival, reducing the risk of disease progress or death by 39% (HR=0.61, 95% CI: 0.50,0.75), p<0.0001).
the results of the study will be presented to the FDA as validated test results in support of converting accelerated approval into full approval.
it will also support global regulatory applications.
The survival results obtained by Padcev in a validated trial are good news for patients who continue to progress after platinum-containing chemotherapy and immunotherapy," said Dr. Roger Dansey, chief medical officer at Seattle Genetics.
" References: sttle Genetics and Astellas Announce PADCEV® (enfortumab vedotin-ejfv) Greater Improved Survival In Phase 3 Trial in Previously Treated Local advanced or Metastatic Urothelial Cancer. Retrieved September 18, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .