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.

Selected bladder cancer projects
Product Company Status Setting
Keytruda Merck & Co Approved 2L or 1L chemo-ineligible
Tecentriq Roche Approved 1L chemo-ineligible
Imfinzi Astrazeneca Approved 2L
Opdivo Bristol-Myers Squibb Approved 2L
Bavencio Merck KGaA/Pfizer Approved 2L
Balversa (erdafitinib) Johnson & Johnson/Otsuka Approved 2L, FGFR2/3 alterations
Enfortumab vedotin Seattle Genetics/Astellas Phase III 2L (post platinum & PD-(L)1)
Vicinium Sesen Bio Phase III 2L (post BCG)
UGN-101 (mitomycin C) Urogen Pharma Phase III Not specified
Qapzola (apaziquone) Spectrum Pharmaceuticals Phase III Not specified
Sacituzumab govitecan Immunomedics Phase II ≥2L
RX-3117 Rexahn Pharmaceuticals Phase I/II ≥2L
Source: EvaluatePharma & clinicaltrials.gov.

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