Pfizer, Merck KGaA's Bavencio sees late-stage trial win in bladder cancer
The Pfizer, Merck KGaA immunotherapy Bavencio, given shortly after initial chemotherapy for advanced bladder cancer, significantly extends survival, according to a late-stage study whose results were reported during the virtual American Society of Clinical Oncology (ASCO) Annual Meeting.
The phase 3 JAVELIN Bladder 100 trial found that Bavencio improved survival by 7.1 months in patients with inoperable locally advanced or metastatic urothelial cancer who had experienced no disease progression after taking chemotherapy as an initial treatment. The trial included 700 patients with inoperable locally advanced or metastatic urothelial carcinoma who had experienced no disease progression following four to six cycles of chemotherapy: gemcitabine plus either cisplatin or carboplatin.
The trial results represent the largest survival benefit seen to date in advanced urothelial cancer in the maintenance setting.
The drug was previously granted an accelerated approval by the FDA in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
In a separate, small phase 2 study also presented at ASCO, Bavencio staved relapse in 8 of 15 women with gestational trophoblastic tumors that couldn’t be treated with single-agent chemo.
