Natera’s Signatera assay has been found to accurately predict if a patient with muscle-invasive bladder cancer (MIBC) will benefit from adjuvant cancer immunotherapy, Tecentriq (atezolizumab) post-surgery in a Phase III trial.
Top-line results of the IMvigor011 study (NCT04660344) revealed that patients given Roche’s Tecentriq after testing positive through the in vitro companion diagnostic (IVD) experienced significant improvements in both disease-free survival (DFS) and overall survival (OS).
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Meanwhile, a preliminary analysis found that patients who remained Signatera-negative post-operation had positive outcomes without adjuvant treatment, with 88% of patients being disease-free 18 months after surgery.
This is the first Phase III study in this indication to use a personalised approach to treatment guided by the presence of circulating tumour DNA (ctDNA), a key biomarker of molecular residual disease (MRD) – which is often associated with an increased risk of relapse.
According to the study’s principal investigator, Professor Thomas Powles, the results of the IMvigor011 trial could “open the door for a new treatment paradigm” in MIBC, helping physicians to more accurately determine if adjuvant treatment is necessary by monitoring the presence of cancer on a molecular level.
This contrast could mark a step up from the previous standard of care (SoC) disease-monitoring techniques such as imaging and bladder endoscopy, which can often at times miss early-stage recurrence events due to their inability to detect MRD in patients.
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By GlobalDataFollowing the trial’s positive outcome, Natera is finalising its premarket approval application to the US Food and Drug Administration (FDA) for Signatera’s use as a companion diagnostic.
If given the go-ahead, Signatera could prevent patients who have no detectable MRD from enduring potentially severe immune-related side effects commonly associated with PD-L1 blockers such as Tecentriq. It would also allow physicians to prescribe treatment in the early stages of relapse.
This is welcome news for the company, as Signatera was previously turned down by the UK’s National Institute for Health and Care Excellence (NICE) for use in the National Health Service (NHS) as a routine MRD test for solid tumours in 2022. This was due to the lack of clinical evidence to support its use when assessing its cost-benefit ratio.
The development also follows Natera’s involvement in one of the largest false advertising verdicts in history, which saw Guardant Health claim $292.5m – including $175.5m in punitive damages – from the company after it falsely advertised the benefits of Signatera over Guardant’s MRD assay, Guardant Reveal.
