On October 24, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the findings from the first Phase II prospective international multi-institutional study to deliver ablative doses of radiation to pancreatic cancer patients will be presented at the 64th Annual Meeting of the American Society for Radiation Oncology (ASTRO), being held October 23-26, 2022, at the Henry B. Gonzalez Convention Center in San Antonio (Press release, ViewRay, OCT 24, 2022, View Source [SID1234622325]). The results will be featured as part of the Special Session of Late-Breaking Abstracts and will take place on Tuesday, October 25, at 3:00 p.m. Central Time. The data will be presented by Parag Parikh, M.D., study’s principal investigator and Director of GI Radiation Oncology and MR-Guided Radiation Therapy at the Henry Ford Cancer Institute in Detroit.
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The trial, titled "Stereotactic MRI-Guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer" – and known as SMART Pancreas (NCT 03621644) – was launched in 2019 in response to compelling retrospective data that suggested the potential for ablative dose radiation to improve overall survival relative to patients receiving lower radiation doses without increasing the rate of severe gastrointestinal toxicity.
In the SMART Pancreas study, 136 patients were treated at 13 international centers with ablative MRIdian SMART, 50Gy over 5 fractions. The study’s primary outcome measured grade 3 or higher gastrointestinal toxicity in the first 90 days after treatment. The study’s primary safety objective was met, with zero incidences of acute grade 3+ GI toxicity definitely-related to SMART treatment.
Secondary measures of the study include overall survival, local control, distant progression-free survival, and changes in patient-reported quality of life. While study patients are still early in the follow-up period, 16.4 months from diagnosis and 8.8 months from SMART treatment, the ASTRO presentation will highlight preliminary clinical outcomes data of 1-year local control and distant progression-free survival were 82.9% and 50.6% respectively. One-year overall survival from diagnosis was 93.9%.
"We are pleased to see this prospective study confirmed our experience using MRIdian for pancreas cancer. Ablative SMART for locally advanced and borderline resectable pancreatic cancer is safe; and is promising to improve patient outcomes in this devastating disease," said Dr. Parikh. This study supports further studies looking at overall survival, such as the LAP-ABLATE randomized study that was recently opened."
The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.
To date, nearly 27,000 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: View Source
Conflicts of interest: Parag Parikh, M.D. discloses research funding and consulting from ViewRay, Inc, and research funding from Galera Therapeutics, Inc. He also discloses stock ownership from Nuvaira, Inc.