Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer
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The findings from the IMvigor011 study regarding muscle-invasive bladder cancer (MIBC) present a significant shift in the post-surgical management of patients. The ability to accurately determine molecular residual disease (MRD) status with Signatera could potentially reduce the need for adjuvant treatments in patients who consistently test MRD-negative. This approach aligns with the precision medicine paradigm, which aims to tailor treatments based on individual patient characteristics, potentially sparing patients from the side effects and costs associated with unnecessary therapy.
From a clinical perspective, the reported overall survival (OS) and disease-free survival (DFS) rates are impressive and suggest that serial MRD testing might serve as a reliable prognostic tool for patient outcomes. However, it is essential to consider the long-term follow-up data beyond the 18-month mark to fully understand the durability of these results. Additionally, the impact on patient quality of life and health economics should be factored into the broader implications of implementing serial MRD testing as standard care.
The data from Natera's Signatera test in the context of the IMvigor011 study could have significant implications for the future of companion diagnostics in oncology. The market for personalized medicine is expanding and the potential FDA approval of Signatera as a companion diagnostic assay could position Natera favorably within this market. The trial's results could enhance the value proposition of Signatera, not just for patients and healthcare providers but also for payers who are increasingly focused on cost-effective, outcome-based treatments.
Investors should monitor the upcoming full trial read-out and FDA review process closely, as these will be critical milestones that could influence Natera's stock performance. The successful validation and approval of Signatera would likely drive adoption and reimbursement, thus potentially increasing Natera's revenue streams in the precision oncology sector.
The utilization of Signatera MRD testing as a means to guide adjuvant therapy decisions represents a notable development in the cost management of cancer care. By potentially reducing the number of patients undergoing unnecessary treatments, healthcare systems could see a decrease in the financial burden associated with cancer therapies, which often include significant direct costs and productivity losses.
However, the economic implications extend beyond immediate treatment costs. The long-term savings associated with improved survival and reduced recurrence rates can be substantial. These savings must be weighed against the cost of the MRD testing itself. As the healthcare industry continues to move towards value-based care, the economic evaluation of such diagnostic tools will become increasingly important in policy-making and insurance coverage decisions.
Data demonstrates that MIBC patients who remain Signatera MRD-negative after surgery may be spared from adjuvant treatment, with
Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy. Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs. placebo. Patients who remain Signatera-negative at completion of the testing window are not randomized but continue to undergo radiographic imaging thereafter.
The analysis presented at the EAU Congress evaluated clinical outcomes in 171 high-risk MIBC patients who entered screening for IMvigor011 and remained MRD-negative during the surveillance window. Key takeaways from the presentation include:
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Overall survival (OS) rates of
100% at 12 months and98% at 18 months, in patients who remained serially MRD-negative. -
Disease-free survival (DFS) rates of
92% at 12 months and88% at 18 months, in patients who remained serially MRD-negative. - Concludes that patients who remain MRD-negative on serial testing may be spared from adjuvant treatment.
“IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle-invasive bladder cancer,” said John Simmons, vice president, BioPharma at Natera. “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients. Together with Professor Powles and our collaborators at Genentech, we look forward to the full trial read-out which could serve as the basis of Natera’s first FDA companion diagnostic submission for Signatera.”
This presentation follows a study published in Nature based on the phase III randomized IMvigor010 trial, which showed that patients who tested Signatera MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy with atezolizumab, while Signatera-negative patients derived no significant benefit from adjuvant therapy.
As previously announced in October 2023, Natera submitted the first module of its premarket approval application to the
Note: Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.
About Natera
Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
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Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com
Source: Natera, Inc.
FAQ
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