Jan 06, 2020: Merck and Pfizer Inc, announced the Phase III JAVELIN Bladder 100 study met its primary endpoint on the whole survival (OS) at the planned interim analysis.
In this study, patients deals with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease does not progress on induction chemotherapy and who were randomized to accept first-line maintenance therapy with BAVENCIO® (avelumab) and best supportive care (BSC) lived considerably longer than those who received BSC only.
A statistically noteworthy improvement in OS was demonstrated in the BAVENCIO arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors.
 The safety profile for BAVENCIO in the trial was reliable with that in the JAVELIN monotherapy clinical development program.
The results of the study will be submitted for the presentation at an upcoming medical congress and shared with the U.S. FDA and other health authorities.
UC accounts with 90% of all bladder cancer. When the bladder cancer is metastatic, the five-year survival rate is 5%, then combination chemotherapy is currently the first-line standard of care for the patients with advanced disease, but despite high initial response rates, strong and complete responses following first-line chemotherapy are uncommon, and most patients will eventually experience disease progression within nine months after initiation of treatment.
FDA approved BAVENCIO 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 neo-adjuvant or adjuvant treatment with the platinum-containing chemotherapy.
This indication is approved below accelerated approval based on tumor response and duration of response. JAVELIN Bladder 100 is the confirmatory study for the conversion towards full approval.
https://www.merckgroup.com/en/news/bavencio-bladder-100-06-01-2020.html
