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A prospective, multicenter, international randomized controlled trial will compare 2-year overall survival in patients with pancreatic cancer receiving post-chemotherapy SMART ablative MRI versus chemotherapy alone

DENVER, Oct. 18, 2022 /PRNewswire/ — View Ray, Inc. (NASDAQ: VRAY) today announced the initiation of a Phase III randomized controlled trial titled “Locally Advanced Pancreatic Cancer Treated with Stereotaxic MRI-Guided Adaptive Radiation Therapy ABLAtivE” – also known as LAP-ABLATE. LAP-ABLATE will compare stand-alone multi-agent chemotherapy, which is the current standard of care for patients with locally advanced pancreatic cancer, to patients receiving a combination of chemotherapy and MRIdian SMART in 5 fractions (guided adaptive radiotherapy by stereotactic MRI). The study is designed to demonstrate superior overall survival in patients receiving dian SMART post-chemotherapy MRI. The planned recruitment target is 267 patients (NCT05585554).

Although surgery is considered a potentially curative treatment for non-metastatic pancreatic cancer, less than 20% of patients are candidates. Of the remaining patients, approximately 40% have locally advanced pancreatic cancer (LAPC) and 40% have distant metastases at the time of diagnosis. LAPC is usually unresectable because the tumor envelops the major abdominal blood vessels.

“This prospective, multicenter, international randomized controlled trial, the first of its kind, was prompted by the exciting results of several recently published ablative SMART MRI studies that demonstrated significantly improved treatment efficacy and reduced toxicity compared to results from non-radiation therapy. ablative,” said Michael D. Chuong, MD, principal investigator of the LAP-ABLATE trial and medical director of radiation oncology at the Miami Cancer Institute, part of Baptist Health South Florida. “While previous studies of chemotherapy and non-ablative radiotherapy have not shown improvement over chemotherapy alone for patients with LAPC, we believe that the advanced capabilities of MRIdian overcome the many limitations of other modalities. Ablative doses with MRIdian SMART can provide pancreatic cancer patients with a clinically meaningful improvement in long-term survival while maintaining an excellent quality of life and rarely causing significant side effects.”

Conventional chemotherapy associated with non-ablative radiotherapy has not demonstrated an improvement in overall survival. Other studies have supported the idea that a significant increase in radiation dose to an ablative range can improve overall survival. But the ability to deliver an ablative radiation dose to the pancreas has always been limited. Previous clinical trials have shown a high risk of injury to the stomach and nearby intestinal loops, leading to serious side effects such as pain, bleeding or obstruction.

“Pancreatic cancer is one of the most difficult diseases to treat, and although currently available therapies may have a significant impact on a proportion of patients, they are not curative for the vast majority,” said Martin Fuss. , MD, Chief Medical Officer at View Ray. “LAP-ABLATE will evaluate the combination of chemotherapy and MRI-guided ablative dose radiation therapy to determine the role of MRIdian in improving overall survival outcomes and expanding treatment options for patients with locally advanced disease.”

MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track soft tissues and tumors. Providing continuous, real-time tracking of the tumor and organs at risk, MRIdian enables automatic radiation synchronization, turning off the beam if the target moves outside of user-defined margins. This allows precise delivery of the prescribed dose to the target while sparing surrounding healthy tissue and critical structures.

“Despite major advances in other oncology indications, treatment options for pancreatic cancer remain very limited, including for patients with locally advanced disease,” said Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network (PanCAN). “At PanCAN, we support patient participation in clinical trials as a way to access some of the best treatment options and the most cutting-edge approaches. We look forward to the results of the LAP-ABLATE trial and the opportunity to validate a potential breakthrough treatment for this patient group. »

To date, more than 25,000 patients have been treated with MRIdian. Currently, 54 MRI systems are installed in hospitals around the world where they are used to treat a wide variety of solid tumors and are the subject of many ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. For a list of treatment centers, please visit: https://viewray.com/mridian-treatment-centers/

Disclaimer:

Nothing in this document is intended to provide specific medical advice or to replace written law or regulation.

Security statement

The MRIdian Linac system is not suitable for all patients, including those who are not candidates for magnetic resonance imaging. Radiation therapies can cause side effects that can vary depending on the part of the body being treated. The most common are usually temporary and may include, but are not limited to, irritation of the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be serious. Treatment sessions can vary in complexity and duration. Radiation therapy is not appropriate for all cancers. You should discuss the potential for side effects and their severity and the benefits of radiation therapy and magnetic resonance imaging with your doctor to make sure radiation therapy is right for you.

About ViewRay

ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® MRI-guided radiotherapy system. MRIdian is built on a proprietary high-definition MR imaging system designed from the ground up to meet the unique challenges and clinical workflow of advanced radiation oncology. Unlike MRI systems used in diagnostic radiology, MRIdian’s high-definition MRI has been specifically designed to address specific challenges including beam distortion, skin toxicity, and other issues that can arise when high magnetic fields interact with beams of radiation. ViewRay and MRIdian are registered trademarks of ViewRay, Inc.

ViewRay is a medical device manufacturer and cannot and does not recommend specific treatment approaches. Individual results may vary. The results described here may not be predictive

Conflicts of Interest: Michael Chuong, MD has received honoraria and research grants from ViewRay, Inc. outside the scope of this study and serves on the Medical Advisory Board of ViewRay, Inc.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Private Securities Litigation Reform Act. Statements in this press release that are not purely historical are forward-looking statements. These forward-looking statements include, among other things, ViewRay’s financial forecast for the full year 2022, expected future orders, expected future operational and financial performance, treatment outcomes, therapy uptake, innovation and performance of MRIdian systems. Actual results could differ from those projected in the forward-looking statements due to many factors. These factors include, among others, the ability to commercialize the MRIdian Linac System, demand for ViewRay’s products, ability to convert backlog into revenue, timing of delivery of ViewRay’s products, timing, and the severity of the COVID-19 pandemic, including its impacts on our on-demand business, global operations and supply chains, results and other uncertainties associated with clinical trials, the ability to raise additional necessary funds to continue to pursue ViewRay’s business and product development plans, the inherent uncertainties associated with the development of new products or technologies, competition in the industry in which ViewRay operates and general market conditions. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to ViewRay’s business generally, see ViewRay’s current and future reports filed with of the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and its Quarterly Reports on Form 10-Q, periodically updated with the other filings by the company with the SEC. These forward-looking statements are made as of the date of this press release, and ViewRay undertakes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. , except as required by law.

View original content: https://www.prnewswire.com/news-releases/viewray-launches-phase-iii-pancreatic-cancer-study-to-demonstrate-superior-overall-survival-for-patients-receiving-mri – guided-ablative-radiation-therapy-301651737.html

SOURCE ViewRay, Inc.


Company Codes: NASDAQ-NMS: VRAY

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