Illumina Introduces New Pan-Cancer Complementary Diagnostic to Match Patients With Rare Gene Mutations to Targeted Therapy

TSO Comprehensive (EU) is a comprehensive genomic profiling (CGP) test that combines less prevalent biomarkers with more prevalent biomarkers in the same test, using a single biopsy sample. This maximizes the chances of identifying an actionable alteration so that patients can be treated with targeted therapy or enrolled in a clinical trial based on their unique tumor genomic profile. The addition of this first specific CDx claim to NTRK gene fusions, a rare but highly actionable biomarker, helps provide patients with this genetic alteration the opportunity to benefit from larotrectinib, a genomically compatible treatment.

“This CDx claim, developed in partnership with Bayer, is the first in a series currently in development, leveraging Illumina’s extensive portfolio of oncology partnerships with industry leaders to advance the diagnosis of cancer and precision medicine,” said Paula DowdySenior Vice President and General Manager of Illumina for Europethe Middle Eastand Africa. “We continue to focus on harnessing the potential of new biomarkers to identify those most likely to benefit from precision medicines so that no patient is left behind. We don’t want anyone to miss the opportunity to have their biomarker detected and have access to a potentially life-saving therapy.”

In most solid cancer tumor types, NTRK gene fusions can have a rare prevalence of 0.1-3% and can be difficult to detect because these genes fuse with many different partners, many of which were previously unknown. Most CDx assays are cancer-type specific, but the NTRK claim is pan-cancer, allowing TSO Comprehensive (EU) to target multiple solid tumor types and a wide range of known and novel gene fusion partners on the three NTRK genes. This maximizes the chances of finding actionable information from each patient’s biopsy, to inform treatment with larotrectinib.

“Since its launch four years ago, VITRAKVI has demonstrated high response rates and very durable responses in adults and children with TRK fusion cancer,” said Christine Rott, a member of the executive committee of Bayer’s pharmaceutical division and head of Bayer’s oncology strategic business unit. “The CE marking of Illumina’s TSO Comprehensive (EU) test including the detection of the NTRK gene fusion for VITRAKVI is an important step forward in enabling precision oncology for patients in Europe. Tests that enable precision oncology through comprehensive genomic testing are essential to inform optimal treatment plans and help ensure the best possible outcomes for cancer patients. We look forward to continuing to collaborate with Illumina to ensure that more patients are comprehensively evaluated, including NTRK gene fusions. »

The performance of TSO Comprehensive (EU) with NTRK fusions has been evaluated by analytical and clinical validation studies. Pooled data from three clinical trials, LOXO-TRK-14001 (NCT02122913), NAVIGATE (NCT02576431), and SCOUT (NCT02637687), were used to demonstrate the clinical efficacy and safety of TSO Comprehensive (EU) in identifying fusion of the NTRK1, NTRK2 and NTRK3 genes positive patients who may be eligible for treatment with larotrectinib. The primary endpoint was overall response rate (ORR), measured when the patient had either a complete response, complete surgical response, or partial response to larotrectinib.

“We were delighted to be Illumina’s clinical study partner in this significant achievement of the first CDx claim for the TSO Comprehensive (EU) panel,” said Prof. Richard Kennedy, Global Vice President of Biomarker Development and Chief Medical Officer, Almac Diagnostic Services. “TSO Comprehensive (EU) represents a powerful and versatile platform with a wide range of cancer-relevant content, and we recognize its value to our biopharmaceutical partners, for the development and delivery of companion diagnostics for other precision medicines.

Illumina has a growing pipeline of CDx claims under development through partnerships with pharmaceutical companies, which will be added to TSO Comprehensive (EU) following appropriate regulatory approvals. These CDx claims will help unlock breakthrough targeted therapies and immunotherapies to make a difference in the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine.

About TruSight Oncology Comprehensive (EU)

TruSight Oncology Comprehensive is a in vitro diagnostic test that uses next-generation targeted sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from cancer patients with malignant neoplasms solids using the Illumina® NextSeq™ 550Dx Instrument. The test can be used to detect single nucleotide variants, multinucleotide variants, gene insertions, deletions and amplifications from DNA, as well as gene fusions and splice variants from RNA. The test also reports a TMB (Tumor Mutational Burden) score and a microsatellite instability (MSI) status.

The test is designed as a companion diagnostic to identify cancer patients for treatment with the targeted therapy listed in Table 1, in accordance with the approved labeling of the therapeutic product. Further, the test is intended to provide tumor profiling information for use by qualified healthcare professionals in accordance with professional guidelines and is not conclusive or prescriptive for labeled use of any specific therapeutic product.

Table 1: Indication of Companion Diagnostics

Type of tumor

Biomarkers

Targeted therapy

Solid tumors

NTRK1, NTRK2 and NTRK3

Gene fusions

VITRAKVI® (larotrectinib)

To learn more about TruSight Oncology Comprehensive, click here.

About VITRAKVI™ (larotrectinib)

VITRAKVI™ (larotrectinib), a first-in-class oral TRK inhibitor, has been exclusively designed to treat tumors that have a NTRK gene fusion. The compound has demonstrated high response rates and very durable responses over four years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. To date, it has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest set of data presented at the European Society for Medical Oncology (ESMO) Congress 2021 and additional updates planned to be presented at future scientific meetings.

Larotrectinib is approved under the brand name Vitrakvi™ in more than 40 countries worldwide, including the United States, countries in the European Union (EU) and, most recently, in China. Deposits in other regions are underway or planned. In the EU, the product is approved for the treatment of adult and pediatric patients with solid tumors that harbor a neurotrophic tyrosine kinase receptor (NTRK) gene fusion, who have locally advanced, metastatic disease or whose surgical resection is likely to lead to severe morbidity, and who do not have satisfactory treatment options.

Use of forward-looking statements

This press release may contain forward-looking statements that involve risks and uncertainties. Among the important factors affecting our business that could cause actual results to differ materially from those set forth in the forward-looking statements include: (i) our ability to manufacture robust instruments and consumables; (ii) challenges inherent in developing, manufacturing and launching new products and services; (iii) our ability to obtain regulatory approval for our products from governmental agencies and reimbursement from payers; (iv) our ability to successfully partner with other companies and organizations to develop new products, expand our markets and grow our business, and other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed during public conference calls, the date and time of which are published in advance. We undertake no obligation and do not intend to update these forward-looking statements, review or confirm analysts’ expectations, or provide interim reports or updates on quarterly progress in Classes.

About Bayer

Bayer is a global company with core competencies in the areas of life sciences healthcare and nutrition. Its products and services are designed to help people and the planet prosper by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to fostering sustainable development and generating a positive impact on its activities. At the same time, the Group aims to increase its profitability and create value through innovation and growth. The Bayer brand is synonymous with trust, reliability and quality around the world. During the 2021 financial year, the Group employed approximately 100,000 people and achieved a turnover of €44.1 billion. R&D expenses before exceptional items amounted to €5.3 billion. For more information, visit www.bayer.com.

About Illumina

Illumina improves human health by unlocking the power of the genome. Our focus on innovation has enabled us to become a global leader in DNA sequencing and chip-based technologies, serving customers in the research, clinical and application markets. Our products are used for applications in life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit www.illumina.com and join us on Twitter, Facebook, LinkedIn, instagramand Youtube.

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SOURCEIllumina, Inc.

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