Prospective multi-center international randomized controlled trial will compare 2-year overall survival in pancreatic cancer patients receiving post-chemotherapy ablative MRIdian SMART vs. chemotherapy alone
DENVER, Oct. 18, 2022 /PRNewswire/ -- ViewRay, Inc. (NASDAQ: VRAY) today announced the launch of a phase III randomized controlled trial titled "Locally Advanced Pancreatic cancer treated with ABLATivE stereotactic MRI-guided adaptive radiation therapy" – 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 5-fraction MRIdian SMART (stereotactic MR-guided adaptive radiotherapy). The study is designed to demonstrate superior overall survival in patients receiving post-chemotherapy MRIdian SMART. The anticipated enrollment target is 267 patients (NCT05585554).
Although surgery is considered a potentially curative treatment for non-metastatic pancreatic cancer, less than 20 percent of patients are candidates. Of the remaining patients, approximately 40 percent have locally advanced pancreatic cancer (LAPC), and another 40 percent have distant metastases at diagnosis. LAPC is usually not resectable because the tumor encases major abdominal blood vessels.
"This first-of-its-kind prospective multi-center international randomized controlled trial was prompted by the exciting results of several recently published ablative MRIdian SMART studies that demonstrated markedly improved treatment efficacy and reduced toxicity compared to outcomes from non-ablative radiation therapy," said Michael D. Chuong, M.D., lead investigator of the LAP-ABLATE trial and Medical Director of Radiation Oncology at the Miami Cancer Institute, part of Baptist Health South Florida. "While prior studies of chemotherapy plus non-ablative radiation have not shown an improvement over chemotherapy alone for patients with LAPC, we believe MRIdian's advanced capabilities overcome the many limitations of other radiation treatment modalities. Ablative doses with MRIdian SMART can provide pancreatic cancer patients a clinically meaningful improvement in long-term survival while maintaining an excellent quality of life and rarely causing significant side effects."
Conventional chemotherapy plus non-ablative radiotherapy has not demonstrated improvements to overall survival. Further studies have supported the notion that significantly escalating the radiation dose to an ablative range may improve overall survival. But the feasibility of delivering ablative radiation dose to the pancreas has historically been limited. Previous clinical trials have resulted in a high risk of injury to the stomach and nearby bowel loops, resulting in severe side effects such as pain, bleeding, or obstruction.
"Pancreatic cancer is one of the most challenging diseases to treat, and while currently available therapies can have a meaningful impact for a proportion of patients, they are non-curative for the vast majority," said Martin Fuss, M.D., Chief Medical Officer at ViewRay. "LAP-ABLATE will evaluate the combination of chemotherapy and MRI-guided ablative dose radiation therapy to determine MRIdian's role in improving overall survival outcomes and expanding the treatment options for patients with locally advanced disease."
MRIdian integrates MRI technology, radiation delivery, and proprietary software to locate, target, and track soft-tissue and tumors. By providing real-time continuous tracking of the tumor and organs-at-risk, MRIdian enables automatic gating of the radiation, turning the beam off if the target moves outside user-defined margins. This allows for 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 severely 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 involvement in clinical trials as a way to gain access to some of the best treatment options and most cutting-edge approaches. We're looking forward to the results of the LAP-ABLATE trial and the opportunity to validate a potential breakthrough therapy for this group of patients."
To date, over 25,000 patients have been treated with MRIdian. Currently, 54 MRIdian systems are installed at hospitals around the world where they are used to treat a wide variety of solid tumors and are the focus of numerous 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/
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you.
ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures, and markets the MRIdian® MRI-Guided Radiation Therapy System. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian's high-definition MR was purpose-built to address specific challenges, including beam distortion, skin toxicity, and other concerns that potentially may arise when high magnetic fields interact with radiation beams. 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 herein may not be predictive
Conflicts of Interest: Michael Chuong, M.D. has received honoraria and research grants from ViewRay, Inc. outside of the scope of this study and serves on the Medical Advisory Board of ViewRay, Inc.
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. Such forward-looking statements include, among other things, ViewRay's financial guidance for the full year 2022, anticipated future orders, anticipated future operating and financial performance, treatment results, therapy adoption, innovation, and the performance of the MRIdian systems. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to commercialize the MRIdian Linac System, demand for ViewRay's products, the ability to convert backlog into revenue, the timing of delivery of ViewRay's products, the timing, length, and severity of the COVID-19 pandemic, including its impacts across our businesses on demand, our operations and global supply chains, the results and other uncertainties associated with clinical trials, the ability to raise the additional funding needed to continue to pursue ViewRay's business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates, and overall market conditions. For a further 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 in general, see ViewRay's current and future reports filed with 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, as updated periodically with the Company's other filings with the SEC. These forward-looking statements are made as of the date of this press release, and ViewRay assumes 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.
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