Veracyte Announces New Data to be Presented at ASCO 2022 Showing Immunoscore IC Assay’s Ability to Identify Patients with NSCLC Who May Benefit from Immune Checkpoint Inhibitors

Rhea-AI Summary

Veracyte, Inc. (Nasdaq: VCYT) announced data from a clinical study showcasing the Immunoscore Immune Checkpoint (IC) assay's ability to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs). Presented at the ASCO Annual Meeting on June 6, the study involved 265 patients, revealing that 100% of those with a high-risk score relapsed within 18 months, while a significant proportion of low-risk patients did not relapse for at least 36 months. The findings aim to enhance patient selection in clinical trials and optimize treatment approaches.

Positive

• Immunoscore IC assay predicts NSCLC patient response to ICIs, which may improve treatment outcomes.
• Study results could help biopharmaceutical companies select appropriate patients for clinical trials, enhancing trial success rates.

Negative

• None.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (Nasdaq: VCYT) announced today new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT.

“Immune checkpoint inhibitors have revolutionized therapeutic management of patients with metastatic non-small cell lung cancer,” said Jérôme Galon, Ph.D., of Inserm, the National Institute of Health and Medical Research in France, and Veracyte. “Unfortunately, current biomarkers are limited for identifying responders as only a handful of these patients benefit from ICIs. Our findings are exciting because they underscore the Immunoscore IC assay as a tool for predicting which patients may benefit from ICIs, potentially avoiding the use of costly drugs and unnecessary additional toxicity for non-responder patients.”

For the study, researchers evaluated the Immunoscore IC assay in two independent cohorts totaling 265 patients who were treated with anti-PD1 or anti-PD-L1 antibodies (immune checkpoint inhibitors). The Immunoscore IC assay provided a risk score that was significantly associated with patients’ progression-free survival and overall survival. Within the two cohorts, all patients (100 percent) with a “high-risk” Immunoscore IC result relapsed in less than 18 months. In contrast, 34 percent and 33 percent of patients with a “low-risk” Immunoscore IC result did not relapse for a period of at least 36 months, in each cohort.

“These findings suggest that the Immunoscore IC assay may help biopharmaceutical companies select the right patients, helping to improve the success rate of their clinical trials, notably in combination trials including ICIs,” said Corinne Danan, general manager for Veracyte’s Biopharma business unit. “Further, we believe the test’s use could help enable patients who are unlikely to respond to ICIs to enter into novel, combination-immunotherapy trials.”

About Immunoscore IC

Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company that improves patient care by answering important clinical questions to inform diagnosis and treatment decisions. Our growing menu of advanced diagnostic tests help patients avoid risky, costly procedures and interventions, and reduce time to appropriate treatment. Our tests address eight of the 10 most prevalent cancers by incidence in the United States. In addition to making our tests available in the United States through our central laboratories, our exclusive license to a best-in-class diagnostics instrument positions us to deliver our tests to patients worldwide through laboratories that can perform them locally. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to our clinical tests, assays, biopharma business opportunities and immuno-oncology offerings. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," “suggest,” "may," "will" “prospective,” “potential” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. An example of a forward-looking statement includes, among others, that the Immunoscore IC assay is intended as a tool for predicting which patients may benefit from ICIs. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 28, 2022, and our subsequent quarterly reports on Form 10-Q. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

Veracyte, the Veracyte logo, HalioDx, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, Immunoscore, TMExplore, Brightplex, Immunosign, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and selected countries. Immunoscore IC is a trademark of Veracyte SAS registered in France. Immunoscore is a registered trademark of Inserm used by Veracyte under license. nCounter is the registered trademark of NanoString Technologies, Inc. in the U.S. and selected countries and used by Veracyte under license.

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Investors:

Shayla Gorman

Director, Investor Relations

investors@veracyte.com

619-393-1545

Media:

Tracy Morris

Vice President of Global Corporate Communications

tracy.morris@veracyte.com

650-380-4413

Source: Veracyte, Inc.

FAQ

What is the significance of the Immunoscore IC assay in lung cancer treatment?

The Immunoscore IC assay helps predict which metastatic non-small cell lung cancer patients may benefit from immune checkpoint inhibitors, potentially improving treatment strategies.

When will the findings of the Immunoscore IC assay study be presented?

The findings will be shared at the ASCO Annual Meeting on June 6.

How many patients were evaluated in the Immunoscore IC assay study?

The study evaluated two cohorts totaling 265 patients treated with immune checkpoint inhibitors.

What were the relapse rates associated with the Immunoscore IC results?

All high-risk patients relapsed within 18 months, while 34% and 33% of low-risk patients did not relapse for at least 36 months.