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.

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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.

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.

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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.

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]).

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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.

On December 10, 2020 CG Oncology, Inc., a clinical-stage biopharmaceutical company focused on the development of novel oncolytic immunotherapies, reported the closing of a $47 million Series D preferred stock financing led by new investor Kissei Pharmaceutical Co., Ltd., with participation from existing investors ORI Healthcare Fund, Camford Capital and Perseverance Capital Management (Press release, CG Oncology, DEC 10, 2020, View Source [SID1234572621]).

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The financing will support the advancement of CG Oncology’s late-stage clinical programs for its lead oncolytic immunotherapy, CG0070, including an ongoing global Phase 3 trial (BOND3) with CG0070 as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC), and a combination Phase 2 study (CORE1) of CG0070 with KEYTRUDA (pembrolizumab) in the same indication. In addition, a Phase 1b study (CORE2) is currently ongoing with CG0070 in combination with OPDIVO (nivolumab) as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients.

"We are excited to close our Series D round of funding, which will allow us to advance our late-stage pipeline, as new treatment options are desperately needed for patients with bladder cancer," said Arthur Kuan, CEO of CG Oncology. "Our clinical progress in oncology is a testament to oncolytic immunotherapy as a novel approach, with our lead candidate CG0070 in both monotherapy and combination therapy studies. The support of leading global investors comes at a pivotal time for CG Oncology, with our lead monotherapy program advancing to BLA, and our combination programs of CG0070 with approved anti-PD-1 antibody therapies advancing in the clinic."

"CG Oncology has made significant progress in advancing its late-stage oncolytic immunotherapy programs, and we have strong expertise to successfully develop and commercialize CG0070 in Japan, and other countries," said Mutsuo Kanzawa, Chairman and CEO of Kissei. "We look forward to working closely with CG Oncology to address the significant unmet medical needs in oncology with this innovative therapy."

On December 10, 2020 Novocure (NASDAQ: NVCR) reported the first patient has been enrolled in its global phase 3 TRIDENT trial, a randomized study in newly diagnosed glioblastoma (GBM) testing the potential survival benefit of initiating Optune concurrent with radiation therapy (Press release, NovoCure, DEC 10, 2020, View Source [SID1234572620]).

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Currently, Optune with maintenance temozolomide is used to treat adults with glioblastoma, following maximal debulking surgery and completion of radiation therapy. However, preclinical studies demonstrate Tumor Treating Fields can be used synergistically with radiation therapy, due to increased tumor sensitivity to radiation therapy, further inhibiting DNA damage repair.

Trident will enroll 950 newly diagnosed GBM patients who, after surgery or biopsy, are candidates for radiation therapy and temozolomide. The experimental group will receive Optune concurrent with radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. The control group will receive radiation therapy and temozolomide for six weeks, followed by Optune and temozolomide. Patients will continue on Optune for 24 months or until second tumor progression, whichever occurs first.

"We are excited to have begun our TRIDENT trial in newly diagnosed GBM," said Dr. Ely Benaim, Novocure’s Chief Medical Officer. "The TRIDENT trial represents our commitment to extending survival for GBM patients. We look forward to our partnership with the hundreds of patients who will participate in this study, their families and caregivers, and the nearly 100 leading institutions who have committed to this important research in GBM."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells with specific membrane properties. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information

Contraindications

Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.