AUSTIN, Texas - Natera, Inc. (NASDAQ: NASDAQ:NTRA), a leader in cell-free DNA testing, in collaboration with the Alliance for Clinical Trials in Oncology, announced the initiation of a significant clinical trial, Alliance A032103 (MODERN), to evaluate the use of molecular residual disease (MRD) testing in treating muscle-invasive urothelial cancer (MIUC).
The trial will enroll about 1,000 patients across over 300 sites in North America to determine the efficacy of personalized treatment pathways.
The MODERN trial is a randomized, phase II/III, biomarker-integrated study that will utilize Natera's Signatera MRD test following radical cystectomy in patients with MIUC. The test is designed to detect and quantify trace amounts of cancer DNA in the body, potentially enabling earlier intervention and more precise treatment.
Patients in the trial will be divided into two groups based on MRD status. Those who test MRD-positive will receive either nivolumab, a PD-1 antibody, or a combination of nivolumab and relatlimab, a LAG-3 antibody. MRD-negative patients will be randomized to continue with nivolumab or to enter a surveillance program, receiving treatment only if they convert to MRD-positive status.
The launch of this trial follows the FDA's approval of adjuvant nivolumab for MIUC based on the CheckMate 274 trial, which established the safety and efficacy of the therapy in this setting. The decision to utilize Signatera in the MODERN trial also draws on data from the IMvigor010 trial, suggesting that MRD-negative patients may not benefit significantly from adjuvant immunotherapy compared to observation.
Matthew Galsky, MD, a leading figure in bladder cancer treatment, highlighted the trial's potential to refine immunotherapy use post-surgery, tailoring care to individual patient needs. Minetta Liu, MD, Natera's chief medical officer of oncology, expressed gratitude for the collaboration with the Alliance in this pivotal study.
Signatera is a personalized test available for various cancer types and is covered by Medicare for select cancers, including MIUC. Natera is known for its commitment to personalized genetic testing and diagnostics, with its tests supported by extensive clinical validation.
This trial represents a step towards precision medicine in bladder cancer treatment and may help optimize patient care by personalizing immunotherapy based on molecular status. The information for this article is based on a press release statement.
InvestingPro Insights
Natera, Inc. (NASDAQ: NTRA) has recently made headlines with the initiation of the Alliance A032103 (MODERN) clinical trial, leveraging their expertise in molecular residual disease (MRD) testing. As the company moves forward with this significant step in precision medicine, investors and stakeholders are closely monitoring Natera's financial and operational metrics to gauge the company's market position and future prospects. Here are some insights based on real-time data from InvestingPro and InvestingPro Tips:
The company's market capitalization stands robust at $11.04 billion, reflecting investor confidence and the scale of Natera's operations in the genetic testing industry. Despite a challenging environment for profitability, with analysts not expecting the company to be profitable this year, Natera's revenue growth remains strong. Over the last twelve months leading up to Q1 2023, the company has seen a 31.99% increase in revenue, indicating a solid demand for its testing services.
InvestingPro Tips suggest that Natera has been experiencing a high return over the past year, with a particularly strong return over the last three months, marked by a 46.01% price total return. Moreover, the company's stock is trading near its 52-week high, at 95.03% of the peak value, showcasing the positive market sentiment towards Natera's growth trajectory and its role in advancing precision medicine.
It's important to note that Natera operates with a moderate level of debt and its liquid assets exceed short-term obligations, providing financial stability and the ability to navigate through operational challenges. However, the company is trading at a high Price / Book multiple of 14.43, which suggests a premium valuation compared to its book value of assets.
For readers looking to delve deeper into Natera's financials and for more tailored insights, there are additional InvestingPro Tips available. By visiting https://www.investing.com/pro/NTRA and using the coupon code PRONEWS24, readers can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription. This exclusive offer opens access to a comprehensive list of tips, including 6 more that provide valuable context and guidance for informed investment decisions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.