GRAIL and Ochsner Health Launch New Initiatives to Improve Cancer Detection Rates in Louisiana

On June 3, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Ochsner Health (Ochsner) reported a multi-faceted partnership to improve cancer detection rates in Louisiana using Galleri, GRAIL’s multi-cancer early detection (MCED) blood test (Press release, Grail, JUN 3, 2022, View Source [SID1234615535]). Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer the Galleri test by prescription to eligible patients in Louisiana to advance the delivery of cancer care.

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The partnership includes the launch of a MCED Health Equity Demonstration Program, an initiative to improve cancer detection rates for underserved populations in Louisiana and to develop a model for deployment of innovative technologies in community settings. In addition to deploying Galleri, the initiative includes identification of educational and access gaps and barriers to cancer screening, co-creation and development of patient education materials, and community outreach to improve awareness and education about early cancer detection. Utilization of GRAIL’s REFLECTION registry program and other Ochsner data will evaluate the impact of the three-year program, with results to be published following the program’s conclusion.

"Unfortunately, Louisiana has some of the nation’s highest cancer death rates, but we are making strides every year in identifying cancers early through screenings," said Brian Moore, MD, FACS, medical director, Ochsner Cancer Institute. "For those cancers that are historically not diagnosed quickly, offering Galleri to our patients will be revolutionary."

More than 600,000 people die from cancer each year in the U.S., including more than 9,600 in Louisiana, according to the American Cancer Society. This is in large part because some of the deadliest cancers are found too late when outcomes are often poorer. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk adults, lung. In fact, 71% of cancer deaths have no recommended early detection screening.

"This partnership with GRAIL reinforces and aligns with our Healthy State initiative, a 10-year commitment to improving the overall health of the state, which includes collaborations and continued investment in the health of our communities," said Warner Thomas, president and CEO, Ochsner Health. "Through this partnership, we have an opportunity to take a key step toward our goals by addressing an important health equity issue in Louisiana and supporting more than 7,500 underserved patients who visit our community centers."

In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today. GRAIL’s Galleri test has a false positive rate under 1% and it can predict where cancer originated with 89% accuracy.

"We are excited to join forces with Ochsner in this effort as both organizations have a shared vision for increasing early cancer detection and a focus on improving outcomes in underserved communities," said Bob Ragusa, chief executive officer at GRAIL. "By jointly launching a real-world evidence program to evaluate the impact of Galleri, we can not only help make a difference for underserved populations, but also collect critical insights that will help us develop a best-practice roadmap for integrating MCED testing that can be scaled and brought to other communities, helping to bridge the health equity gap in cancer detection."

Ochsner’s academics and research team will also begin enrolling participants aged 50 years and older who are not actively being evaluated or treated for cancer in the ongoing PATHFINDER 2 study. This is a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in North America. Participants who have a "cancer signal detected" test result will undergo a targeted diagnostic evaluation based on predicted cancer signal origin(s) through the Ochsner Cancer Institute to determine if cancer is present.

Medidata Presents Critical Research on Identifying Predictors of Severe Cytokine Release Syndrome in CAR T Therapy at ASCO 2022

On June 3, 2022 Medidata, a Dassault Systèmes company, reported that new research on predicting cytokine release syndrome (CRS) resulting from longitudinal CAR T-cell therapy (CAR T) at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7 in Chicago (Press release, Medidata, JUN 3, 2022, View Source [SID1234615534]).

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"CAR T therapy has been a significant innovation in cancer care – but as with any new and complex therapy, it has brought its own challenges and problems to solve. CRS – a life-threatening toxic immune reaction to CAR T therapy – has been seen in a meaningful number of patients and has led to at least 15 clinical trial failures for new therapies since 2016," said Jacob Aptekar, MD, vice president at Medidata. "Many known physiological markers that could indicate risk for severe CRS are difficult to measure but the study presented at ASCO (Free ASCO Whitepaper) is an important step in demonstrating how commonly collected laboratory tests – like a complete blood count (CBC) – can be used to assess CRS risk in a large number of patients across multiple clinical trials, indications, and CAR T products."

Titled "Predictors of severe CRS in longitudinal CAR T-cell clinical trial data," the study used the company’s Medidata Acorn AI platform to analyze 542 patients pooled from multiple clinical trials. These are significantly more patients than previous CRS studies, which have traditionally used a limited number of patients from a single clinical trial or clinical site. The Medidata study demonstrated notable differences in commonly measured biomarkers including platelet counts, serum albumin concentration, creatinine levels, and neutrophil counts between patients who experience severe CRS versus those who do not.

The Medidata study includes a conclusion that a Risk Evaluation and Mitigation Strategy for CRS may be warranted for CAR T therapy, both during clinical trials and in real-world use, using periodic monitoring of common lab markers to assess the risk level and enable early intervention when warranted.

"The trend across oncology is towards precision treatment and research. This Medidata study is a critical piece of that puzzle for CAR T therapy, empowering both researchers and health care providers to better understand the safety and efficacy of treatments in specific patients," said Michael Kattan, PhD, the Dr. Keyhan and Dr. Jafar Mobasseri Endowed Chair for Innovations in Cancer Research and chairman, Department of Quantitative Health Sciences at the Cleveland Clinic. "By understanding where the warning signs for CRS are, we can design safer trials, avoid and better understand trial failures, and get better and safer innovative treatments to more patients in more care settings."

Medidata Acorn AI leverages the company’s rich, regulatory grade clinical data, machine learning and AI capabilities, and pharmaceutical product development expertise to drive value for the life sciences community. Built upon the Medidata platform, comprising more than 28,000 trials and more than eight million patients and healthy volunteers across 140-plus countries, Acorn AI solutions feature the industry’s largest structured, standardized clinical trial data repository connected with real-world, translational, and other datasets.

To learn more about this study and about Medidata Acorn AI, please visit Medidata’s booth (#3037) or visit its show website.

Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

Naveris Announces Abstract Accepted for Presentation at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting

On June 3, 2022 Naveris, Inc. reported the presentation of an abstract related to its flagship diagnostic test for TTMV-HPV DNA (NavDx) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from June 3 through June 7, 2022 in Chicago and virtually (Press release, Naveris, JUN 3, 2022, View Source [SID1234615533]).

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Results of TTMV-HPV DNA testing in the NRG-HN002 phase II clinical trial for patients with p16-positive oropharynx cancer treated with intensity-modulated radiation therapy (IMRT), with or without cisplatin chemotherapy, will be shared in the presentation.

Details of the presentation are as follows:

Oral Presentation
Abstract: 6006
Title: Association of plasma tumor tissue modified viral HPV DNA (TTMV) with tumor burden, treatment type, and outcome: A translational analysis from NRG-HN002.
Presenter: Sue S. Yom, M.D., Ph.D., Professor and Vice Chair, Strategic Advisory, Department of Radiation Oncology; Professor, Otolaryngology-Head and Neck Surgery, Univ. of California San Francisco (UCSF)
Presentation Session Date/Time: The oral presentation will take place on Friday, June 3, 2022 from 3:45 – 6:45 p.m. EDT, during the session titled "Head and Neck Cancer"
Location: In-Person & Live Stream | S406

Following the presentation, the data presented will be available on the Naveris website at View Source

Forma Therapeutics to Present at the Jefferies Healthcare Conference

On June 3, 2022 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that it will participate in the Jefferies Healthcare Conference taking place June 8-10, 2022 (Press release, Forma Therapeutics, JUN 3, 2022, View Source [SID1234615532]). Forma will present on June 9, 2022 at 2:00 p.m. Eastern Daylight Time (EDT).

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A webcast of the conference presentation will be available in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.

Foundation Medicine Partners with Lung Cancer Research Foundation and the Lung Cancer Mutation Consortium on Screening Trial to Enable Precision Therapy

On June 3, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC) (Press release, Foundation Medicine, JUN 3, 2022, View Source [SID1234615531]). This screening trial, entitled "LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer" (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicine’s FDA-approved CGP tests: the tissue-based FoundationOneCDx and the blood-based FoundationOneLiquid CDx.

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The LEADER trial is utilizing an umbrella trial design to screen for 11 actionable driver mutations in 1,000 patients with high-risk, resectable non-small cell lung cancer (NSCLC). These patients are candidates for neoadjuvant therapy, which is treatment given as a first step to shrink a tumor before the main treatment, often surgery. By identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials, the LEADER trial aims to develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery.

"The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC," says Dr. Geoff Oxnard, Foundation Medicine’s VP, Head of Clinical Development. "At Foundation Medicine, we are committed to being an engaged collaborator in the pivotal research needed to shape the future of cancer care for patients at all stages, so that patients can get on the right therapy at the right time for their specific cancer."

The results from both FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for actionable driver mutations. While circulating tumor DNA (ctDNA) shed is often lower in early disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC.

In the past two years, the FDA has granted approvals for the first tyrosine kinase inhibitor and checkpoint inhibitor, respectively, for the adjuvant treatment of resected NSCLC, each requiring testing for precision biomarkers. The FDA has also recently granted approval for neoadjuvant immunotherapy for resectable NSCLC, as well as the first-and-only immunotherapy-based treatment for neoadjuvant use in NSCLC, reinforcing the value of targeted therapies as a component of curative lung cancer. These FDA approvals could better position early-stage NSCLC patients, like those who are enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.

The LEADER trial is now open to enrollment and will include participation from trial sites and investigators across the oncology community, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Yale Cancer Center/Smilow Cancer Hospital and many others.

In a new "Trial in Progress" abstract being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting from June 3-7, Boris Sepesi, M.D., associate professor of Thoracic and Cardiovascular Surgery at The University of Texas MD Anderson Cancer Center, and principal investigator of the LEADER Trial, and Mark Kris, M.D., Attending Physician, Thoracic Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center will detail LEADER’s primary objective of determining the proportion of resectable NSCLC patients within the trial who possess actionable oncogenic drivers. Results from Foundation Medicine CGP testing will inform the LEADER trial sites on their selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies or other trials if no driver is detected. Read more on ASCO (Free ASCO Whitepaper).org, and visit Foundation Medicine at Booth #13019 to learn more. Follow along on Twitter and LinkedIn for more details about Foundation Medicine’s data being presented at ASCO (Free ASCO Whitepaper)22.