Phase III JAVELIN Bladder 100 trial of avelumab meets primary overall survival endpoint at planned interim analysis in urothelial carcinoma

Study in 700 patients with previously untreated locally advanced/metastatic urothelial carcinoma whose disease didn’t progress on induction chemotherapy, reported those receiving the drug and best supportive care (BSC) lived significant longer than patients who received BSC alone

The FDA approved avelumab in 2017 for treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after platinum-based chemotherapy or whose disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. It was approved under accelerated approval based on tumour response and duration of response. JAVELIN Bladder 100 was conducted to allow for full approval by the FDA.

In UK, Avelumab is only licensed for the treatment of metastatic Merkel cell carcinoma and advanced renal cell carcinoma.