Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics
company with the mission to improve patient outcomes by providing
personalized insights that inform critical decisions throughout the
patient care journey, today announced that DetermaIO™, the
Company’s proprietary test designed to determine the likelihood of
benefit of immune checkpoint inhibitors (ICIs), was featured in a
podium presentation at the European Society of Medical Oncology
(ESMO) World Congress on Gastrointestinal Cancer 2022, held in
Barcelona, Spain from 29 June-2 July, 2022. The presentation will
include a summary of DetermaIO’s performance in the AtezoTRIBE
cohort for metastatic colorectal cancer as well as present new
exploratory data with the same study.
After the Company validated its established
endpoint for the DetermaIO test at the 2022 American Society of
Clinical Oncology (ASCO) Annual Meeting, investigators from the
AtezoTRIBE study conducted an exploratory analysis of the trial
data to identify patients who would derive maximal benefit from
receiving immunotherapy in addition to chemotherapy by establishing
an optimized IO score cut-point (IOOPT), adopted to dichotomize
tumors as IOOPT+ or IOOPT-.
The AtezoTRIBE study previously demonstrated
that the addition of the ICI Tecentriq (atezolizumab) benefited
some patients with metastatic colorectal cancer (mCRC), but that
the current biomarker, which identifies only about 5% of those with
colon cancer, misses a significant fraction of responders. For the
other 95% of patients, those with proficient mismatch repair (pMMR)
tumors, identifying a subgroup able to achieve benefit from ICIs is
an urgent unmet need. As part of the validation data presented at
ASCO 2022, researchers assessed the role of DetermaIO to predict
clinical benefit from the addition of an ICI to first-line
chemotherapy in patients with mCRC, finding that 27% of patients in
this study were DetermaIO positive. Identification of these
patients had a significant association with progression free
survival (PFS) regardless of whether they were in the pMMR group or
not.
“We believe that metastatic colorectal cancer is
a terrific opportunity for DetermaIO to become a CDx for ICI
therapy given there is a very large patient population who today
have no access to IO therapy,” said Ron A Andrews, CEO of Oncocyte.
“While early, we have identified a patient population that will
benefit from immune therapy and provide a chance to extend life
expectancy where today there is very little hope. To date, we have
repeatedly shown that DetermaIO’s assessment of the Tumor
Microenvironment is predictive of response across multiple solid
tumor types and across the four top Immunotherapies on the market
today. Dr. Antoniotti’s presentation is further validation of a
previous study in mCRC, and provides supporting evidence for
further studies that may expand DetermaIO to its fourth validated
tumor type for CMS submission.”
The ESMO GI oral presentation, titled An
immune-related gene expression profile predicts the efficacy of
adding atezolizumab to first-line FOLFOXIRI/bevacizumab in
metastatic colorectal cancer: a translational analysis of the phase
II randomized AtezoTRIBE study, highlights how researchers
found that within the unstratified cohort of patients from
AtezoTRIBE, IOOPT+ tumors more frequently had a high amount of
tumor mutational burden and longer PFS. When stratifying by
treatment arm, IOOPT+ tumors saw significantly higher PFS for
patients who received chemotherapy plus immunotherapy versus those
who received chemotherapy alone.
Based on these results, researchers concluded
that the optimized, exploratory threshold may help to predict
benefit from the addition of immunotherapy to chemotherapy in colon
cancer, even within the 95% of patients with pMMR tumors, as was
seen in the data presented by the Company at ASCO.
“This exploratory analysis is an exciting build
upon previously validated data for DetermaIO,” said Carlotta
Antoniotti, Assistant Professor of Internal Medicine at the
University of Pisa. “Identifying a subgroup of pMMR patients able
to achieve benefit from treatment with an ICI is a crucial
challenge of translational research, and we look forward to further
exploring the optimized IO cut points in independent metastatic
colorectal cancer cohorts.”
DetermaIO was launched via an Early Access
Program in Q4 of 2021 and is the first and only commercial test to
assess multiple components of the tumor immune microenvironment
(TIME), giving insight into the biology of the tumor that allows
for physicians and their patients to make informed decisions about
their treatment journey. Data from Oncocyte to date show that the
test identifies patients who respond to ICIs – including Keytruda®,
Opdivo®, Tecentriq® and Imfinzi® – in lung, bladder, kidney,
triple-negative breast, colon, and gastric cancers, suggesting a
pan-cancer utility for the test in both primary and metastatic
settings.
About OncocyteOncocyte is a precision
diagnostics company with a mission to improve patient outcomes by
providing personalized insights that inform critical decisions
throughout the patient care journey.
Through its proprietary tests and pharmaceutical services
business, the Company aims to help save lives by accelerating the
diagnosis of cancer and advancing cancer care. The Company’s tests
are designed to help provide clarity and confidence to physicians
and their patients at every stage. DetermaRx™ identifies
early-stage lung cancer patients who are at high risk for cancer
recurrence and who may benefit from adjuvant chemotherapy.
DetermaIO™ is a gene expression test that assesses the tumor
microenvironment to predict response to immunotherapies. The
Company’s pipeline of tests in development also includes
DetermaTx™, which will assess mutational status of a tumor,
DetermaCNI™, a blood-based monitoring test, DetermaMx™, a long-term
recurrence monitoring test, and VitaGraft™, a blood-based solid
organ transplantation monitoring test. In addition, Oncocyte’s
pharmaceutical services provide companies that are developing new
cancer treatments a full suite of molecular testing services to
support the drug development process.
DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™, DetermaMx™ and
VitaGraft™ are trademarks of Oncocyte Corporation.
Forward-Looking StatementsAny statements that
are not historical fact (including, but not limited to statements
that contain words such as “will,” “believes,” “plans,”
“anticipates,” “expects,” “estimates,” “may,” and similar
expressions) are forward-looking statements. These
statements include those pertaining to, among other
things, expectations related to DetermaIO, such as
the opportunity in metastatic colorectal
cancer for DetermaIO to become a CDx for ICI
therapy, and other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management. Forward-looking statements involve risks and
uncertainties, including, without limitation, the potential impact
of COVID-19 on Oncocyte or its subsidiaries’ financial
and operational results, risks inherent in the development and/or
commercialization of diagnostic tests or products, uncertainty in
the results of clinical trials or regulatory approvals, the
capacity of Oncocyte’s third-party supplied blood sample analytic
system to provide consistent and precise analytic results on a
commercial scale, potential interruptions to supply chains, the
need and ability to obtain future capital, maintenance of
intellectual property rights in all applicable jurisdictions,
obligations to third parties with respect to licensed or acquired
technology and products, the need to obtain third party
reimbursement for patients’ use of any diagnostic
tests Oncocyte or its subsidiaries commercialize in
applicable jurisdictions, and risks inherent in strategic
transactions such as the potential failure to realize anticipated
benefits, legal, regulatory or political changes in the applicable
jurisdictions, accounting and quality controls, potential greater
than estimated allocations of resources to develop and
commercialize technologies, or potential failure to maintain any
laboratory accreditation or certification. Actual results may
differ materially from the results anticipated in these
forward-looking statements and accordingly such statements should
be evaluated together with the many uncertainties that affect the
business of Oncocyte, particularly those mentioned in the
“Risk Factors” and other cautionary statements found in
Oncocyte’s Securities and Exchange Commission (SEC)
filings, which are available from the SEC’s website. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Oncocyte undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
Investor ContactCaroline CornerICR Westwicke
Tel:
415.202.5678 caroline.corner@westwicke.com
Media ContactMegan KernanICR Westwicke
Healthcare
PRTel: 646.677.1870megan.kernan@westwicke.com
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