Hunting a full OK for Bavencio in frontline bladder cancer, Pfizer, Merck KGaA receive VIP treatment at FDA
The JAVELIN Bladder 100 study was one of the rare bright spots in Bavencio’s checkered development record. Now Pfizer and Merck KGaA get to burnish that with a breakthrough therapy designation for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.
The partners have submitted their sBLA, which is now being reviewed on a real-time basis. Under that pilot program — which began in late 2018 — regulators could access data prior to the official application filing.
Pfizer and Merck KGaA would have applied for the RTOR at the beginning of this year, when it released topline results of a Phase III study with Bavencio. As a maintenance therapy, the PD-L1 drug hit the mark on overall survival for both the total patient group and a subset with PD-L1 positive tumors.
The drug was already sanctioned, under accelerated approval, for use in patients following disease progression — an OK cemented by tumor response and duration of response back in 2017.
“For the past 30 years, chemotherapy has been the first-line standard of care for patients with advanced urothelial carcinoma. While this is an effective short-term option for many patients, most will ultimately experience disease progression, underscoring a need for additional treatment options,” said Petros Grivas, a principal investigator in the JAVELIN Bladder 100 trial.
In the trial, Bavencio was added to the regimen for patients whose disease had not progressed during or following platinum-containing chemo. The OS results could be practice-changing, Grivas added.
Chris Boshoff, Pfizer’s chief development officer in oncology, highlighted that Bavencio is the first immunotherapy to demonstrate an OS benefit in first-line, locally advanced or metastatic urothelial carcinoma.
AstraZeneca provided the latest illustration on just how tough it can be to beat this advanced cancer when Imfinzi flopped an open label pivotal study last month. The therapy — which also blocks PD-L1 — nabbed accelerated approval in 2017 but failed to help patients live longer compared to standard-of-care chemotherapy. The drugmaker may shift their focus to the second-line setting, it indicated to Endpoints News.