Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer
First of its kind study in muscle-invasive urothelial cancer, with both escalation and de-escalation arms
Approximately 1,000 patients will be enrolled at more than 300 sites
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Urothelial cancer is the most common urinary cancer diagnosed in
In the Alliance A032103 (MODERN) trial, approximately 1,000 patients will be enrolled at more than 300 sites in
This trial was made possible by results of the pivotal CheckMate 274 trial,4 which established the safety and efficacy of adjuvant nivolumab in MIUC, and is now the only FDA-approved therapy in this disease setting.5 Additionally, data published in the journal Nature in 2021 from the IMvigor010 trial showed that 63% of patients with MIUC tested Signatera MRD-negative after surgery, and those patients received no significant benefit from adjuvant immunotherapy (atezolizumab) versus observation.6
“The MODERN trial represents a step towards precision medicine in bladder cancer treatment,” said
“MODERN, like the CIRCULATE clinical trials in colorectal cancer, is a pivotal study that examines how Signatera-guided escalation and de-escalation pathways can potentially improve patient outcomes,” said
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
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Forward-Looking Statements (Natera)
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
References
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Source:
Kantar Health (Cerner Enviza) estimate. - Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19(3):666-75.
- Tian J, Sun J, Fu G, et al. Population-based outcome of muscle-invasive bladder cancer following radical cystectomy: who can benefit from adjuvant chemotherapy? Transl Androl Urol. 2021;10(1):356-373.
- Bajorin D, Witjes JA, Gschwend JE, et al. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. N Engl J Med. 2021;384(22):2102-2114.
- Nivolumab Package Insert. https://packageinserts.bms.com/pi/pi_opdivo.pdf
- Powles T, Assaf ZJ, Davarpanah N, et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature. 2021;595(7867):432-437.
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