Natera’s Signatera Boosts Outcomes in Bladder Cancer, Set for FDA Filing

Natera’s Signatera assay has demonstrated strong clinical utility in muscle-invasive bladder cancer (MIBC), accurately predicting which patients benefit from adjuvant immunotherapy in the Phase III IMvigor011 trial (NCT04660344).

Patients who tested MRD-positive via Signatera and received Roche’s Tecentriq (atezolizumab) after surgery showed significant improvements in disease-free survival (DFS) and overall survival (OS). Conversely, a preliminary analysis showed that 88% of Signatera-negative patients remained disease-free 18 months post-surgery without adjuvant treatment.

This marks the first Phase III trial to apply a personalised MRD-guided strategy in MIBC, offering a potential upgrade from standard monitoring methods like imaging and endoscopy, which often miss early recurrences. Study lead Professor Thomas Powles said the findings could “open the door for a new treatment paradigm” in bladder cancer.

Natera is now finalising a premarket approval (PMA) application to the US FDA for Signatera as a companion diagnostic. If approved, the assay could spare MRD-negative patients unnecessary toxicity from PD-L1 inhibitors while enabling earlier intervention in those at higher risk of relapse.

24-08-2025