Clovis’s bladder cancer failure hints at need for targeted approach

It is remarkable that Clovis’s discontinuation of Rubraca’s bladder cancer study, Atlas, caused a 12% share price decline this morning: bladder cancer was not expected to become a major use for the Parp inhibitor, and Clovis slipped out Atlas’s futility analysis failure in a late Friday SEC filing. Still, some analysts had been talking up Atlas, even if most attributed no value to it. And, though checkpoint blockade has made inroads in urothelial bladder cancer, options for patients who have failed platinum chemo and immuno-oncology are limited. Leerink analysts stressed that Atlas had not preselected for BRCA mutants or HRD-positive subjects, though as a reason for its failure it is hard to square this with Clovis’s earlier claim that as many as 60% of bladder cancers might carry HRD positivity. The need to understand bladder cancer’s underlying cause was highlighted by the approval, coincidentally also on Friday, of Johnson & Johnson’s Balversa (erdafitinib), for second-line patients with FGFR2 or FGFR3 alterations. FGFR inhibitors are thought also to have promise in another rare cancer, cholangiocarcinoma. The US FDA on Friday called Balversa the first targeted therapy for metastatic bladder cancer.