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Liquid Biopsy Predicts Esophageal Cancer Patient Response to Treatment

On December 10, 2020 Creatv MicroTech, a privately-held biotechnology company reported that it has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT) (Press release, CREATV MICROTECH, DEC 10, 2020, View Source [SID1234572626]). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. "We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood," said Dr. Cha-Mei Tang, CEO of Creatv. "Now, patients who are not responding to CRT can be identified quickly for alternative therapy." Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

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In the United States, 18,440 new cases are expected in 2020 for esophageal cancer, a disease that has the sixth highest cancer mortality rate. Even localized disease has a 5-year survival rate of less than 50%, making timely treatment decisions critical to patient outcome. The ability to monitor a patient’s response to therapy throughout treatment will allow for more precise adjustment to therapeutic regimes to optimize the management of the disease. In a completely novel concept, the test analyzes patients’ immune response to the presence of cancer, isolating cells from cancer sites that have migrated into the blood stream. Creatv demonstrated that a particular subtype of cell, Cancer Associated Macrophage-Like cells (CAMLs), tracks the patient’s response to therapy in real time. CAMLs are phagocytic myeloid cells that reveal the patient’s immunological response to active malignancy. CAMLs are not found in the blood of normal, healthy individuals.

Creatv has previously shown that in solid tumors, patients with CAMLs larger than 50 µm in size have a poorer prognosis, with shorter progression free survival (PFS) and overall survival (OS). In this paper, Creatv presents the findings from a two-year single blind prospective study of 32 esophageal cancer patients with Stage I-III treated with standard CRT. A CAML size of ≥50 µm in blood drawn immediately after the completion of CRT indicates a poor prognosis compared to patients with CAMLs < 50 µm, with a Hazard Ratio (HR) =12.0 for progression free survival (PFS) 95% CI 2.7-54.1, p=.004.

The paper is available here.

About LifeTracDx Liquid Biopsy

Creatv’s liquid biopsy assays (LifeTracDx) are commercialized Research Use Only tests designed for analysis of CAMLs and Circulating Tumor Cells (CTCs). LifeTracDx tests are applicable for cancer screening, companion diagnostics, prediction of treatment response (including immunotherapy) and prognosis. LifeTracDx tests also provide unfragmented tumor DNA for sequencing and can predict minimal residual disease (MRD) and early detection of cancer recurrence. LifeTracDx tests are currently used in more than 20 clinical trials, from basic research to drug development. Creatv’s publications have shown that LifeTracDx liquid biopsy can be used for multiple solid tumor cancers as an early predictor of patient response to therapy.

Physicians’ Education Resource® Delivers Cutting-Edge Cancer Management Strategies During Two High-Impact Annual Meetings in December

On December 10, 2020 Physicians’ Education Resource, LLC, (PER) is leading the industry this month with two high-impact, reported that continuing medical education–certified interactive annual conferences on cancer management on Saturday, Dec. 12 (Press release, Physicians’ Education Resource, DEC 10, 2020, View Source [SID1234572625]).

These virtual conferences will deliver value for oncologists across cancer tumor types. Clinicians can kick-start their day hearing expert perspectives on the advantages of currently available liquid-based and tissue-based testing approaches and continue their day discussing new and emerging tumor biomarkers that drive personalized treatment with oncology immunotherapies with world-renowned oncology experts.

"PER is committed to producing specific, impactful programming to help health care professionals stay up to date on the latest data, biomarkers and patient care strategies," said Phil Talamo, CHCP, president of PER. "Throughout these two highly anticipated cutting-edge virtual conferences, our learners will be able to attend specific tumor type sessions and discuss cancer management strategies in real time with expert faculty."

The PER cancer management interactive virtual conferences on Dec. 12 are:

4th Annual Precision Medicine Through Plasma: Using Liquid Biopsies in Contemporary Oncology Care will be a live conference led by returning co-chair Benjamin P. Levy, M.D. In this innovative half-day program, health care professionals will learn about current applications and examine emerging developments, all aimed at individualizing treatment for patients with cancer. To register, click here.

5th Annual International Congress on Immunotherapies in Cancer: Focus on Practice-Changing Application will be a full-day, live conference led by returning co-chairs Naiyer Rizvi, M.D., and Mario Sznol, M.D. Using a mix of brief presentations, panel discussions and case reviews, this meeting will engage participants and provide clinicians with immunotherapeutic strategies based on emerging data. These strategies can be directly applied to day-to-day management of lung cancers, melanoma, genitourinary cancers and hematologic malignancies. To register, click here.

Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine

On December 10, 2020 Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), reported a new collaboration designed to provide broader access to genomic testing and tailored treatment approaches for the oncology community (Press release, Bayer, DEC 10, 2020, View Source [SID1234572624]). The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing testing, via the Tempus xT broad-panel genomic sequencing assay, for a subset of patients with metastatic colorectal cancer (mCRC), as well as those with radioactive iodine refractory differentiated metastatic thyroid carcinoma (RAIR thyroid cancers). Looking ahead, Bayer and Tempus will continue to implement data-enriched initiatives dedicated to supporting patients.

Bayer’s commitment to precision oncology is currently supported by its approach to research that prioritizes targets and pathways that impact the way cancer is treated. The Tempus xT broad-panel genomic sequencing assay is designed to detect actionable driver alterations, including BRAF, KRAS, RET, and NTRK gene fusions.1 NTRK gene fusions are genomic alterations that drive tumor growth regardless of where they originate in the body.2-4 These genomic alterations typically occur following DNA damage, which results in structural changes to the DNA either through biological changes or from environmental factors (e.g. ultraviolet light damage).2-4 During the DNA damage repair mechanism, the NTRK gene can fuse with an unrelated gene resulting in an altered TRK fusion protein, which causes a constant signaling cascade, driving tumor growth and its metastasis (progression).2-4 Studies suggest NTRK gene fusions are present in approximately 3% of patients with mCRC with prior high microsatellite instability (MSI-H) status and 2.4%-12% of patients with RAIR thyroid cancers.5-7

Testing early and utilizing comprehensive genomic profiling is critical, as it helps physicians understand the underlying driver of DNA alterations for tumor progression (growth).8,9 When actionable alterations are detected, they aid physicians in the treatment decisions appropriate for their patients.10 The Tempus xT broad-panel genomic sequencing assay detects these alterations by sequencing tumor samples with matched normal saliva or blood samples, when available, covering 648 genes.1 The test is used by many oncologists across a diverse set of clinical settings, including leading academic centers, NCI designated cancer centers, hospital networks and community hospitals.

"Bayer’s strong focus in precision medicine combined with Tempus’ unique testing offering has culminated in this collaboration to bring genomic testing to cancer patients," said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "We are excited for the potential of this initiative to identify patients who may benefit from tailored treatment options."

"This strategic collaboration aims to provide eligible colorectal and thyroid cancer patients with broad based access to our genomic test to help their physicians make treatment decisions," said Ryan Fukushima, Chief Operating Officer of Tempus.

Healthcare professionals with eligible patients from the above tumor types can receive additional information by learning more at Tempus.com/bayerprogram and contacting Tempus at [email protected].

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Lucence Receives CLIA Certification for US Laboratory, Expands Access to Amplicon-Based Liquid Biopsy Tests

On December 10, 2020 Molecular diagnostics company Lucence reported that the company’s Palo Alto laboratory received certification from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (Press release, Lucence, DEC 10, 2020, View Source [SID1234572623]). With this accreditation, Lucence will rapidly scale United States-based testing capacity for its flagship liquid biopsy blood test, LiquidHALLMARK, furthering the Company’s mission of advancing precision cancer care for the benefit of patients everywhere.

Dr. Tan Min-Han, Founding CEO of Lucence, said, "We are excited to expand our operations to offer the benefits of highly accurate amplicon-based liquid biopsy — quicker, more precise biomarker detection and less invasive testing — to even more patients. Our goal is to make non-invasive, ultrasensitive detection of clinically relevant biomarkers more accessible to oncologists across the country."

This milestone marks accelerating momentum in the company’s US operations. Early next year, Lucence will launch its first major prospective, observational study. LIQUIK, Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer, will compare different liquid biopsy technologies with conventional tissue-based profiling in patients with newly diagnosed metastatic non-squamous non-small cell lung cancer to evaluate the clinical utility of LiquidHALLMARK.

LiquidHALLMARK covers a wide range of clinically relevant biomarkers, including mutations in 80 genes, fusions in 10 genes, and somatic variants in 15 cancer types. LiquidHALLMARK is powered by AmpliMARK, the Company’s proprietary amplicon-based sequencing technology, which uses a unique molecular barcode and error-correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational technological innovation in Lucence’s liquid biopsy tests.

Earlier this year, the Company presented data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating high sensitivity of AmpliMARK at a limit of detection (LOD) of 0.1% variant allele frequency, detecting clinically relevant biomarkers in lung, breast and blood cancers. AmpliMARK demonstrated 97.4% concordance for recommended biomarkers in lung cancer when compared orthogonally with another liquid biopsy platform. CLIA-certification of the Company’s Palo Alto laboratory now ensures accelerated delivery of LiquidHALLMARK’s high resolution, target-rich insights to US clinicians and patients.

Results from APHINITY Trial using BluePrint® as a Biomarker Assay Presented at SABCS in Poster Spotlight Discussion

On December 10, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported data from the APHINITY trial in a poster spotlight discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 10, 2020, View Source [SID1234572622]).

The poster, titled Prediction of benefit from adjuvant pertuzumab by BluePrint RNA sequencing in the APHINITY trial, outlines data from an exploratory analysis of the Phase 3 study that randomized 4,805 patients with histologically centrally confirmed HER2+ early breast cancer into two arms, one which received standard adjuvant chemotherapy and trastuzumab plus pertuzumab, and one which received standard adjuvant chemotherapy and trastuzumab plus placebo, for one year. The analysis was conducted in collaboration with Roche Pharmaceuticals.

At median follow up of 45 months, the primary analysis of the study showed a significant invasive disease-free survival benefit for patients treated with pertuzumab. In this analysis, BluePrint, Agendia’s 80-gene molecular subtyping test, was used to evaluate a subset of tumor samples to identify which patients in the APHINITY trial population would benefit from the addition of pertuzumab based on gene expression profiling of their tumors. The poster presented at SABCS showed that BluePrint may identify subgroups of patients within the study population with differing degrees of benefit from the addition of pertuzumab based on gene expression.

"What is exciting about these data is that we are going back to look deeper at the genomic makeup of tumors in the APHINITY cohort to better understand how these cancers respond to therapy," said Ian Krop, M.D., Ph.D., Associate Chief, Division of Breast Oncology at the Dana-Farber Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and first author on the poster. "It reveals interesting trends that need to be studied further but could ultimately provide information to make more precise treatment decisions right at diagnosis."

With further research, this trend could offer HER2+ breast cancer patients and their doctors early information at the beginning of their journeys that could help them define the path ahead.

"The findings from the APHINITY trial are encouraging and warrant further investigation to see if offering genomic profiling to clinically HER2+ patients routinely could have a meaningful impact on their outcomes," said Adam Brufsky, M.D., Ph.D., Medical Director of the Magee-Womens Cancer Program, part of the UPMC Hillman Cancer Center, and Professor of Medicine at the University of Pittsburgh School of Medicine.

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.