iCAD’s Xoft Brain IORT Demonstrates Significant Improvement in Overall Survival in Recurrent Glioblastoma According to Comparative Study
Patients
treated with Xoft Brain IORT lived for a range of 4 to 54 months after
treatment without recurrence, whereas patients in the control group had a
recurrence within 2 to 10 months and lived for 2 to 22.5 months after treatment
NASHUA, N.H. – August
31, 2021 – iCAD,
Inc. (NASDAQ: ICAD), a global medical technology
leader providing innovative cancer detection and therapy solutions, today
announced that encouraging results from a prospective two center comparative
study evaluating the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for
the treatment of recurrent glioblastoma (GBM), were presented at the American
Association of Neurological Surgeons (AANS) 2021
annual scientific meeting held virtually last week.
The
study, titled “Recurrent Glioblastoma Management with Maximal Safe
Resection and Intraoperative Balloon Electronic Brachytherapy: Two Centers
Study,” is under the guidance of lead investigator, Alexey Krivoshapkin,
professor and head of the neurosurgery department at the European Medical
Center (EMC) in Moscow, Russia. The comparative study evaluated 15 patients
with
recurrent GBM who were treated with maximal safe resection and Xoft
intraoperative radiation therapy (IORT), and 15 patients treated with maximal
safe resection and other modalities (control group), between June 2016 and June
2019.
In the
IORT group, as of March 2021, both the overall survival (OS) and local
progression free survival (locPFS) continued to be superior to those in the
control group. The median OS after re-resection was 11.0 months for the IORT
group, versus 8.0 months for the control group; the median locPFS for IORT was
8.0 months, versus 6.0 months for the control group. Patients treated with Xoft
Brain IORT lived for a range of 4 to 54 months after treatment without
recurrence, whereas patients in the control group had a recurrence within 2 to
10 months and lived for a range of 2 to 22.5 months after treatment.
“The interim
results from this comparative study are very promising and the data adds to a
growing body of research validating Xoft intraoperative radiation therapy
(IORT) as an innovative treatment option for a variety of cancers, including
recurrent GBM,” said Michael Klein, Chairman and CEO of iCAD. “GBM is one of
the deadliest of cancers and recurrence almost always occurs. This innovative
application for the Xoft System has the potential to not only impact patients’
quality of life but also to extend their survival, as further evidenced by this
important research presented during the major neurosurgery conference, AANS.”
Researchers
also found there were fewer complications for the IORT group, as only two
patients in the IORT arm developed radionecrosis, versus four patients who
developed radionecrosis in the control arm. One patient from the IORT
group was still alive when this data was collected, whereas none of the
patients in the control group survived.
Additionally, a
subgroup analysis of patients with post-operative contrast-enhancing volume
(POCEV) of ≤ 2.5cm3 showed more favorable outcomes for patients in the IORT
group. The median locPFS for the 8 patients treated with IORT in this subgroup
was 16.5 months, whereas the median locPFS for the control group was 8.0
months. The median OS after re-resection for the IORT group was 21.25 months,
versus 11.0 months for the control group. Researchers concluded that
the results are encouraging and that further clinical trials are warranted.
“Treatment options
for patients with recurrent GBM are extremely limited,” said Alexey Gaytan, MD,
PhD, a neurosurgeon at the EMC, and the ePoster author presenting at AANS. “As
such, we are encouraged by the interim results that demonstrate significant
improvement in OS and locPFS in recurrent GBM patients with maximal safe
resection plus Xoft Brain IORT compared to re-resection followed by various alternative
adjuvant therapy options (mostly external beam re-irradiation plus
chemotherapy). This innovative approach is equivalent to multiple sessions of
external beam radiation therapy (EBRT), yet with minimized risk of radiation
dose to neighboring healthy tissues. We encourage collaboration on further
multidisciplinary, multicenter clinical trials as the initial data is promising.”
To investigate the potential benefit of Xoft IORT beyond
recurrent GBM, iCAD is developing an observational patient registry to capture
and analyze data from all patients with any type of brain tumor treated with
IORT. The results of this registry will help identify patients who may benefit
most from IORT and to help clinicians understand the place of IORT in an
overall therapeutic regimen for brain tumors.
In addition, an international
multi-center study—the GLIOX trial—is designed to compare Xoft IORT plus
Avastin® (bevacizumab) to the investigational
arm of RTOG-1205 (EBRT plus bevacizumab)
to help confirm early Xoft IORT results previously reported.
“We continue to be
inspired by the widespread interest from worldwide key opinion leaders and
international centers in Xoft Brain IORT and the GLIOX trial to evaluate this
new approach to local control of recurrent GBM,” said Klein.
Worldwide, 308,102
new cases of brain and nervous system tumors were diagnosed in 2020.[i]
In the U.S., the incidence of metastatic brain tumor diagnosis is approximately
200,000 people annually.[ii]
GBM is the most common and aggressive type of malignant primary brain tumor,
with a median survival of 10-12 months.[iii],[iv]
Treatment for brain tumors typically involves surgical removal, followed by
radiation therapy or chemotherapy.
The Xoft System is FDA-cleared, CE marked and licensed in a
growing number of countries for the treatment of cancer anywhere in the body.
It uses a miniaturized x-ray source to deliver a precise, concentrated dose of
radiation directly to the tumor site while minimizing the risk of damage to
healthy tissue in nearby areas of the body. IORT with the Xoft System allows
radiation oncologists and surgeons to work together to deliver a full course of
radiation treatment in one day, at the time of surgery, while the patient is
under anesthesia. Once the tumor has been surgically removed, the Xoft System’s
miniature x-ray source is inserted inside a flexible balloon-shaped applicator,
which is then placed inside the tumor cavity, filled with saline, and used to
deliver a single dose of radiation directly to the tumor bed. For the treatment
of certain types of brain tumors, IORT with the Xoft System may allow
appropriately selected patients to potentially replace weeks of post-operative
EBRT with a single fraction of radiation.
About iCAD, Inc.
Headquartered
in Nashua, NH, iCAD is a global medical technology leader providing innovative
cancer detection and therapy solutions. For more information, visit www.icadmed.com and www.xoftinc.com.
Forward-Looking Statements
Certain
statements contained in this News Release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements about the future prospects for the Company’s
technology platforms and products. Such forward-looking statements involve a
number of known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of the Company to be
materially different from any prior results, performance or achievements
expressed or implied by such forward-looking statements. Such factors include,
but are not limited, to the Company’s ability to achieve positive results from
this or any future studies, business and strategic objectives, the ability of
IORT to provide flexibility, mobility or other advantages, to be more
beneficial for patients than traditional therapy or to be accepted by patients
or clinicians, the impact of supply and manufacturing constraints or
difficulties, product market acceptance, possible technological obsolescence of
products, increased competition, litigation and/or government regulation,
changes in Medicare or other reimbursement policies, risks relating to our
existing and future debt obligations, competitive factors, the effects of a
decline in the economy or markets served by the Company; and other risks
detailed in the Company’s filings with the Securities and Exchange Commission.
The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,”
“continue,” “anticipate,” “likely,” “seek,” and similar expressions identify
forward-looking statements. Readers are cautioned not to place undue reliance
on those forward-looking statements, which speak only as of the date the
statement was made. The Company is under no obligation to provide any updates
to any information contained in this release. For additional disclosure
regarding these and other risks faced by iCAD, please see the disclosure
contained in our public filings with the Securities and Exchange Commission,
available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1 (212) 915-2568
###
[i]
WHO, IARC, Globocan Cancer Incidence and Mortality Worldwide in 2020. Accessed
via
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
[ii]https://www.abta.org/tumor_types/metastatic-brain-tumors/
[iii]
Tamimi AF, Juweid M. Epidemiology and Outcome of Glioblastoma. In: De
Vleeschouwer S, editor. Glioblastoma [Internet]. Brisbane (AU): Codon
Publications; 2017 Sep 27. Chapter 8. Accessed via
https://www.ncbi.nlm.nih.gov/books/NBK470003.
[iv]
Pan E, Prados MD. Glioblastoma Multiforme and Anaplastic Astrocytoma. In: Kufe
DW, Pollock RE, Weichselbaum RR, et al., editors. Holland-Frei Cancer Medicine.
6th edition. Hamilton (ON): BC Decker; 2003. Accessed via
https://www.ncbi.nlm.nih.gov/books/NBK12526/.