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Predicting Response to Immunotherapy: Assessing  the Tumor Micro-Environment to Achieve Better Predictive Value than PD-L1 and TMB

In Case you Missed our Live Webinar

Featuring Dr. Naoto Ueno of the MD Anderson Cancer Center

We discussed exciting data from MD Anderson and how DetermaIO utilizes the Tumor Micro-Environment to achieve better predictive value than PD-L1 and TMB.

Click HERE for the Recording or click the button on the Right.

Key summary points:

  • There is a clear need for better biomarkers to identify patients who are likely to benefit from immune checkpoint inhibitor therapies.
  • The DetermaIO test is a 27-gene expression signature that measures three distinct facets of the tumor and its immune micro-environment to determine sensitivity and/or resistance to IO therapies.
  • Data presented in non-small cell lung cancer showed that DetermaIO was a better predictor of response than PD-L1 expression and TMB. A similar study by MD Anderson and Yale, presented at the 2020 ASCO Annual Meeting, showed better predictive ability than PD-L1 in triple-negative breast cancer.
  • DetermaIO is currently available as an RUO assay. Additional clinical trials and validation studies are planned or underway to explore the clinical utility of DetermaIO across multiple cancer types. 

Up to 750,000 patients may be eligible for immunotherapy each year, yet today more than half of patients treated with immunotherapy won’t respond. There continues to be a critical unmet need for a predictive biomarker that can identify responders and non-responders at diagnosis.

DetermaIO is a novel test that measures expression of 27 genes from the tumor microenvironment and uses a proprietary algorithm to predict response to immunotherapies. 

In this webinar, we presented results from two studies showing the association of DetermaIO with response to checkpoint inhibitor therapy in non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). Both studies suggest that DetermaIO outperformed PD-L1 and/or TMB in predicting immunotherapy response. The studies were led by multiple leading academic institutions, including the University of Texas MD Anderson Cancer Center, Yale University, the Baylor College of Medicine, and the University of Tennessee Health Science Center.

Dr. Naoto Ueno discussed results from an MD Anderson/Yale study that were presented at this year’s virtual ASCO meeting in TNBC.

Dr. Doug Ross discussed previously reported results in NSCLC that showed DetermaIO’s improved ability to predict response to immunotherapies over current leading biomarkers (PD-L1 expression & TMB).

Click HERE for the Recording

Triple Negative Breast Cancer/Immunotherapy in TNBC:

  • Triple Negative Breast Cancer accounts for 15-20% of all breast cancer cases and is defined by the absence of three common genetic markers: Estrogen Receptor (ER), Progesteron Receptor (PR), and HER2.
  • TNBC tumors tend to be more aggressive with poorer prognosis than other breast cancer tumors, and few options for targeted therapy exist for this patient population.
  • At present, a single immunotherapy has been approved for metastatic PD-L1+ TNBC, however a number of other IO drugs are being studied in a number of different clinical trials to offer additional therapeutic options for TNBC patients


Key Takeaways
  • DetermaIO is a novel tumor microenvironment classifier that measures expression levels of 27 genes and predicts response to immune checkpoint inhibitor therapies in multiple cancer types.
  • Two separate validation studies have shown the association with response to checkpoint inhibitor therapy in non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC).
  • More than half of eligible cancer patients put on immune therapy every year do not respond.
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Naoto Ueno, MD, PhD, FACP
Professor of Medicine, Breast Medical Oncology @MD Anderson Cancer Center
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Doug Ross, M.D., Ph.D.
Chief Medical Officer
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Ronald Andrews
President and CEO
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Mitch Levine
Chief Financial Officer
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Al Parker
Chief Operating Officer
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Padma Sundar
Senior Vice President, Commercial
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Lyndal Hesterberg, Ph.D.
Chief Scientific Officer
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Dr. Kim Dickinson
Vice President, Clinical Operations
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