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DetermaIO™ in Triple-Negative Breast Cancer

KOL Call Recording from September 28, 2021
New RCT ESMO Data on Oncocyte’s Immunotherapy Response Predictor, DetermaIO™
Priyanka Sharma, MD and Giampaolo Bianchini, MD presented new ESMO data on Oncocyte's DetermaIO™ for Immunotherapy Response
Key Takeaways
  • Strong biological rationale exists for the use of immunotherapy in triple-negative breast cancer (TNBC), but there is need for a biomarker that can better predict response to immunotherapies in early-stage TNBC than PD-L1.
  • Based on an analysis of samples from the NeoTRIP randomized trial, the DetermaIO test predicted benefit of neoadjuvant atezolizumab over chemotherapy alone in TNBC, even after adjustment for PD-L1 and stromal tumor-infiltrating lymphocytes (sTILs).
  • This new data, first presented at ESMO, adds to data in over 900 patients across multiple tumor types (lung, breast, bladder, and kidney cancer) and all approved immunotherapies (Keytruda, Opdivo, Imfinzi, and Tecentriq), showing that the DetermaIO test consistently identifies both responders and non-responders missed by current biomarkers (PD-L1 and TMB).


The KOL Webinar featured a presentation by Key Opinion Leaders (KOLs) Priyanka Sharma, MD (University of Kansas Medical Centerand Giampaolo Bianchini, MD (San Raffaele Hospital, Milano, Italy). Dr. Sharma discussed the unmet need for identifying patients with triple-negative breast cancer (TNBC) who will respond to immunotherapy. Dr. Bianchini presented results from the NeoTRIP randomized clinical trial, selected for an oral podium presentation at the ESMO (European Society of Medical Oncology) conference- which evaluated Oncocyte's DetermaIO as a predictive biomarker for immunotherapy response prediction in TNBC. DetermaIO is a pan-cancer proprietary gene expression test that assesses the tumor microenvironment. In studies conducted across multiple tumor types (lung, breast, bladder, and kidney cancer) and all approved immunotherapies (Keytruda, Opdivo, Imfinzi, and Tecentriq), the DetermaIO test has consistently identified both responders and non-responders missed by current biomarkers (PD-L1 and TMB), positioning it to fulfill a well-recognized unmet need for optimizing the use of immunotherapy for more than 1 million patients who are eligible for this treatment each year. The test is run in a CLIA/ CAP-accredited laboratory. It is expected to launch clinically as part of an early access program later this year. The DetermaIO test for immunotherapy treatment selection, and the company’s complementary DetermaCNI test, a proprietary blood-only test for monitoring response to treatment, are designed to enable oncologists to manage patients longitudinally during the course of their cancer treatment. 


New Publication:

A Novel Immunomodulatory 27-Gene Signature to Predict Response to Neoadjuvant Immunochemotherapy for Primary Triple-Negative Breast Cancer



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About Oncocyte 
Oncocyte is a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer. The Company, through its proprietary tests and pharmaceutical services business, 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™, a gene expression test currently used as a research-use only tool, 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, blood-based monitoring test DetermaCNI™, and long-term recurrence monitoring test DetermaMx™. 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™ and DetermaMx™ are trademarks of Oncocyte Corporation.

Oncocyte Forward-Looking Statements
Oncocyte cautions you that this press release contains forward-looking statements. Any 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 the DetermaIO and DetermaCNI tests, including the potential of DetermaIO to fulfill the unmet need for optimizing the use of immunotherapy for more than 1 million patients who are eligible for this treatment each year, the expectation that DetermaIO will launch clinically as part of an early access program later this year and the potential of DetermaIO and DetermaCNI to enable oncologists to manage patients longitudinally during the course of their cancer treatment. 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, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize, 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 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.

For more information, please visit https://oncocyte.com/ or follow us on Twitter at @OncocyteCorp, Facebook, and LinkedIn

Key Takeaways
  • Strong biological rationale exists for the use of immunotherapy in triple-negative breast cancer (TNBC), but there is need for a biomarker that can better predict response to immunotherapies in early-stage TNBC than PD-L1.
  • Based on an analysis of samples from the NeoTRIP randomized trial, the DetermaIO test predicted benefit of neoadjuvant atezolizumab over chemotherapy alone in TNBC, even after adjustment for PD-L1 and stromal tumor-infiltrating lymphocytes (sTILs).
  • This new data, first presented at ESMO, adds to data in over 900 patients across multiple tumor types (lung, breast, bladder, and kidney cancer) and all approved immunotherapies (Keytruda, Opdivo, Imfinzi, and Tecentriq), showing that the DetermaIO test consistently identifies both responders and non-responders missed by current biomarkers (PD-L1 and TMB).
Related Bios
Priyanka Sharma, MD 
Key Opinion Leader
View Full Bio>>
Giampaolo Bianchini, MD
Key Opinion Leader
View Full Bio>>
Contacts
Chelli Miller
chelli@contentcarnivores.com
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