Positive phase II enfortumab vedotin results

In phase II studies involving 125 patients with advanced urothelial cancer that has spread locally or metastasized elsewhere in the body, Astellas and Seattle Genetics’ antibody-drug conjugate enfortumab vedotin (ASG-22ME) shrank 44% of tumors and eliminated 12% of them. This treatment has the potential to be an option for patients whose cancer has worsened despite receiving platinum chemotherapy and checkpoint inhibitors, which are successful for around 20% of patients, and shrink tumors for 11-12 months. Data from the studies showed that 84% of the patients saw some reduction in tumor size, and tumor shrinkage in 44% of patients was sufficient to register them as responders. The treatment extended life by an average of 7.6 months, and progression-free survival was around six months. The response rate was steady across patient subgroups, including those for whom PD-1/PD-L1 blockers did not work, those with liver metastases and those who had received three or more prior treatments.
Andy Krivoshik, Oncology lead at Astellas, said: “This consistency across subgroups demonstrates that there’s not just one group driving the overall benefit that we’re seeing. We are exploring not only moving earlier in the disease continuum, but we’re also looking at other potential tumor types that have high Nectin-4 expression. We are learning from the trial and from biomarker data, and trying to understand the importance of Nectin-4 in other tumor types.”