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.

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

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.

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.

On June 3, 2022 Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, and Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported that the EF-31 phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields (TTFields) together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as a first-line treatment in patients with gastric adenocarcinoma, met its primary endpoint of objective response rate with supportive signals across secondary endpoints (Press release, NovoCure, JUN 3, 2022, View Source [SID1234615530]). TTFields therapy was well tolerated, with no increase in the systemic toxicity of the XELOX chemotherapy regimen or the combination regimen, and no high-grade skin toxicities were reported.

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Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival has not yet been reached with a one-year survival rate of 72%.

"The EF-31 outcomes are encouraging in a historically difficult to treat cancer," said Dr. Jin Li, Head of Department of Oncology, Shanghai East Hospital, Tongji University School of Medicine. "The addition of Tumor Treating Fields to standard-of-care chemotherapy could lead to impactful changes in the treatment of gastric cancer patients and I look forward to confirming these data in additional clinical studies."

The EF-31 clinical study, which is a prospective, single arm, phase 2 pilot study conducted in China, included 26 patients with unresectable, locally advanced or metastatic gastroesophageal junction or gastric adenocarcinoma who were previously untreated with systemic therapy. Patients received continuous treatment with TTFields together with the XELOX chemotherapy regimen (combination of oxaliplatin and capecitabine). Trastuzumab was allowed for HER2-positive patients.

"TTFields therapy is a highly versatile modality with potential for broad applicability across solid tumor types and lines of therapy," said Asaf Danziger, Novocure’s Chief Executive Officer. "We would like to thank our patients, study investigators, and our partners at Zai Lab. The EF-31 results suggest that the addition of TTFields to standard therapies may offer better patient outcomes in gastric cancer and we are eager to continue exploring these potential benefits as we look ahead to a randomized phase 3 clinical study."

"Each year, more than one million new gastric cancer cases are diagnosed worldwide, with approximately half of all gastric cancer cases occurring in China. There is an urgent need to improve therapeutic options," said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab. "EF-31, conducted in China, represents an important milestone as Novocure and Zai work together to expand TTFields into new disease areas. We look forward to working with Novocure in future global clinical studies across multiple solid tumor indications."

About Gastric Cancer

Gastric cancer is the third leading cause of cancer deaths worldwide and the third leading cause of cancer deaths in China. The incidence of gastric cancer is approximately 478,500 new cases annually in China, and approximately 26,000 new cases annually in the U.S.

Current therapies include surgery, chemotherapy, radiotherapy, targeted therapy and recently, immunotherapy. One of the most commonly used chemotherapy regimens for treating gastric cancer is XELOX, a combination of oxaliplatin and capecitabine. In the recent phase 3 trial (CheckMate 649, NCT-02872116, Lancet 2021) studying gastric cancer, the standard-of-care chemotherapy regimens showed an objective response rate range of 41% – 45%, median progression-free survival of 6.9 months, duration of response of 6.9 months, and overall survival of 11.6 months. One-year survival was 48%.

Gastric cancer is the third most-frequent cancer in China. Currently, the five-year survival rate of locally advanced or metastatic gastric cancer ranges from 5% to 20%, and the median overall survival is approximately one year.

About Tumor Treating Fields

Tumor Treating Fields NovoTTF-100L(P) is an investigational device for the treatment of gastric cancer. Safety and efficacy have not been established. Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.