CLEVELAND, June 23, 2020 /PRNewswire/ -- ViewRay, Inc.
(Nasdaq: VRAY) announced today the publication by the European
Urology Oncology Journal of a prospective phase II study of
MR-guided radiation therapy (MRgRT) in patients with localized
prostate cancer. The publication is a follow-up to early outcomes
published in 2019 which reported low incidence of acute toxicity in
both clinician- and patient-reported outcomes. The one-year data
reported continued absence of grade 3 or higher toxicities and
reductions in long-term patient-reported outcome measures after
MRIdian treatment. Researchers from Amsterdam University Medical
Centers enrolled 101 patients and the study is one of the first to
research SBRT in a mix of intermediate- and high-risk prostate
cancer patients, a population that is challenging to treat. The
journal is the official scientific journal of the European
Association of Urology.
All patients received MRgRT in five fractions of 7.25 Gy to the
target volume using adaptive techniques on the MRIdian. The study
did not use implanted markers or tissue spacers between rectum and
prostate because treatments were delivered under MR-guidance,
thereby eliminating the need for an invasive procedure and
potentially reducing associated complications.
Results at 12 months showed that no grade 3 GU or GI toxicities
were observed. These results were obtained in a complex clinical
cohort (59.4 percent high-risk) and are comparable to what would
typically be observed in less-complex populations, pointing to
potential benefits of MR-guided SBRT for this higher risk group.
Little to no grade 2 was reported by patients at 12-month follow up
and, importantly, corresponding bowel problems were reported by
only 2 percent of patients.
"SBRT offers significant promise in the treatment of prostate
cancer. Our study showcases that MRIdian allowed for optimal target
coverage and the use of small planning margins which may directly
contribute to the low toxicity observed at one year," said
principal investigator Anna
Bruynzeel, M.D., Ph.D., Radiation Oncologist at Amsterdam
UMC. "Our findings are in contrast to conventional EBRT data, which
recently reported a negative effect on bowel function at 12-month
follow up. These results reinforce the value of MRIdian's real-time
on-table adaptive treatment with automated beam gating for prostate
cancer patients."
Amsterdam UMC is pioneering efforts in the use of MRIdian SBRT
and the application to treat prostate cancer. Not only is this the
largest prospective clinical trial in the use of MRgRT, but also
the first prospective clinical trial on MR-guided radiation
treatment for prostate cancer without the need for implanted
markers in intermediate- to high-risk patients.
"We have the potential to change the course of radiation therapy
with a shorter treatment schedule, lower potential costs, and
reduction in complications associated with an invasive procedure,"
said Martin Fuss, M.D., Chief
Medical Officer at ViewRay. "MRIdian's capabilities of real-time
soft tissue tracking, on-table adaptative dose planning, and
automated beam gating provide physicians the confidence and tools
they need to deliver a precise and accurate dose while sparing
sensitive structures near the target in order to achieve better
patient outcomes."
The in-press article can be accessed at
https://linkinghub.elsevier.com/retrieve/pii/S2588931120300614.
About the Study
Article in Press in the European
Urology Oncology Journal, titled: "Magnetic Resonance-Guided
Sterotactic Radiotherapy for Localized Prostate Cancer: Final
Results on Patient-Reported Outcomes of a Prospective Phase 2
Study," authored by Shyama U. Tetar,
Anna M.E. Bruynzeel, Swie S. Oei,
Suresh Senan, Tamara Fraikin, Berend
J. Slotman, R. Jeroen A. van Moorselaar, and Frank J.
Lagerwaard. According to the study, "In this prospective phase 2
trial in men with localize prostate cancer, the use of sterotactic
MRgRT for optimal target coverage allowed the use of small planning
margins, a finding that may account for low patient-and
clinician-reported toxicity rates at one-year follow up. The
absence of grade 3+ GI or GU toxicity is encouraging."
Anna M.E. Bruynzeel has received
honoraria from ViewRay, Inc. outside the scope of this study and
has served on the advisory board of ViewRay Inc. Suresh Senan has received research grants from
ViewRay Inc. Berend J. Slotman has
received research grants and honoraria from ViewRay Inc. Frank J.
Lagerwaard has received honoraria from Viewray Inc.
About ViewRay®
ViewRay, Inc. (Nasdaq: VRAY), designs,
manufactures, and markets the MRIdian® MR-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.
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.
About Amsterdam University Medical
Centers
Amsterdam UMC employs more than 15,000
professionals, treating over 350,000 patients per year at both its
sites – AMC and VUmc. Working towards a future in which illnesses
are prevented and the best treatment made available to all
patients, Amsterdam UMC has developed new methods for diagnostics
and treatment together with professionals from other renowned
national and international institutions. The institute's main focus
is on complex patient care and highly-specialized treatment of rare
medical conditions. Amsterdam UMC teaches and trains thousands of
young people to become doctors, specialists or nurses. Its
researchers are clustered in eight research centers so that the
institute can achieve its ambition of executing international,
cutting-edge research. At Amsterdam UMC, AMC and VUmc are working
together on academic patient care, scientific research and teaching
and training.
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 2020, and ViewRay's conference calls to discuss its
quarterly 2020 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, the timing of delivery
of ViewRay's products, the timing, length, and severity
of the recent COVID-19 (coronavirus) pandemic, including its
impacts across our businesses on demand, operations and our 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,
2019 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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SOURCE ViewRay, Inc.