CLEVELAND, April 11, 2019 /PRNewswire/
-- ViewRay, Inc. (Nasdaq: VRAY) announced today the
publication of a retrospective analysis of outcomes for the
stereotactic treatment of locally advanced pancreatic cancer using
precise, high-dose MRI-guided radiation therapy delivered with
MRIdian's on-table adaptive dose planning system. The study,
published in Cancer Medicine, and led by Soumon Rudra, M.D. from
Washington University in St. Louis, demonstrated enhanced overall
survival while resulting in lower levels of toxicity compared to
lower-dose, mostly non-adaptive treatment. These outcomes inspired
the ongoing SMART trial, a multi-institutional prospective trial
intended to assess the outcomes of this retrospective analysis
further.
Researchers at Washington University
in St. Louis, the University of Wisconsin, the University of California Los Angeles, University of Miami, and Amsterdam University
Medical Centers, pooled outcomes from 44 pancreatic cancer patients
treated with the MRIdian system. About half of the patients were
treated with high doses (greater than 70 Gy BED), often with
on-table adaptive planning to improve normal tissue sparing and, in
some instances, to increase the dose to the tumor. The other half
of patients received lower doses (less than 70 Gy BED) and were
less likely to have received on-table adaptive planning. The
high-dose group showed overall survival at two years of 49 percent,
versus 30 percent for the low-dose group. Importantly, no patient
in the high-dose group experienced Grade 3 or higher acute
toxicity, while 7 percent in the low-dose group experienced Grade 3
or 4 toxicity.
Pancreatic tumors and surrounding healthy organs and tissue can
vary significantly in position and size from day to day. This
variation can increase the risk of delivering therapeutic radiation
that damages healthy tissues and organs. Daily MRI guidance enabled
by MRIdian allows clinicians to assess the position of the target
relative to sensitive organs and adjust the treatment plan at the
moment of treatment in order to minimize radiation exposure to
healthy tissues and allow for an increased dose to be delivered to
the disease. The higher dose also provides for a shortened
treatment course versus low dose therapy.
"The combination of on-table adaptive re-planning and real-time
tracking and gating of tumor motion enables us to confidently
deliver very high, potentially curative doses," said Percy Lee, Associate Professor and Vice Chair of
Education, and Director of the Stereotactic Body Radiotherapy
Program at the David Geffen School of Medicine at UCLA. "Locally advanced pancreatic cancer is
notoriously difficult to treat, and the outcomes noted in this
retrospective study are better than expected and very encouraging.
The features of the MRIdian system have a demonstrated potential to
improve treatments for patients with many types of cancer."
"These data suggest that MRIdian-guided adaptive radiotherapy
may help survival while greatly reducing toxicity rates," said
Scott Drake, President and Chief
Executive Officer of ViewRay. "We are pleased to support the
prospective study of this promising finding and thank the
multi-institutional teams for their work to improve patient care
and outcomes."
About the Publication
Published April 1, 2019, in Cancer
Medicine, titled: "Using adaptive magnetic resonance image‐guided
radiation therapy for treatment of inoperable pancreatic cancer",
and authored by Soumon Rudra, Naomi
Jiang, Stephen A. Rosenberg,
Jeffrey R. Olsen, Michael C. Roach, Leping
Wan, Lorraine Portelance,
Eric A. Mellon, Anna Bruynzeel, Frank Lagerwaard, Michael F. Bassetti, Parag J. Parikh, and Percy P. Lee.
According to the publication, "The study was a
multi‐institutional, retrospective, cohort study based on data from
5 institutions. Eligible patients had biopsy‐proven, inoperable,
pancreatic cancer treated with MRgRT from 2014 through 2016. All
patients were evaluated with diagnostic computed tomography (CT)
imaging or MRI. Patients deemed medically inoperable were included
as well. The study excluded patients with prior pancreas‐directed
RT, pancreatic surgery or any clinical‐radiographic evidence of
distant metastasis prior to initiation of RT. Research conformed to
the Helsinki Declaration and satisfied retrospective review
requirements for each institution."
The publication can be viewed at:
https://onlinelibrary.wiley.com/doi/epdf/10.1002/cam4.2100.
About the SMART Trial
The SMART trial is designed to enroll 133 participants with
borderline resectable or inoperable locally advanced pancreatic
cancer. Patients must be 18 years and older and have documented
non-metastatic disease after three months of systemic therapy.
Radiation therapy will be delivered using ViewRay's MRIdian at a
prescribed dose of 50 Gray (Gy) in 5 fractions. Each participant
will be aligned in the treatment system with MRI image-guidance.
On-table adaptive re-planning will be used when clinically
indicated. In all patients, real-time MRI imaging will be used
throughout treatment delivery to monitor the target location and
control the radiation beam as necessary. The primary outcome
measure of the study is grade 3 or higher gastrointestinal toxicity
in the first 90 days after treatment. Secondary measures
include overall survival at two years, distant progression-free
survival at six months and changes in patient reported quality of
life (pre-treatment to 12 months post-treatment and for more
extended periods up to five years).
About ViewRay®
ViewRay, Inc. (Nasdaq: VRAY), designs, manufactures and markets
the MRIdian® 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.
Intended Use
The MRIdian Linac System, with magnetic resonance imaging
capabilities, is intended to provide stereotactic radiosurgery and
precision radiotherapy for lesions, tumors, and conditions anywhere
in the body where radiation treatment is indicated.
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. Such forward-looking
statements include, among other things, the rate of new orders,
upgrades and installations, ViewRay's financial guidance for the
full year 2019 and ViewRay's conference call to discuss its fourth
quarter and year to date results. 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 MRIdian Linac System, demand for ViewRay's products,
the ability to convert backlog into revenue, and the timing of
delivery of ViewRay's products, the timing, 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, 2018, 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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SOURCE ViewRay, Inc.