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.

On June 3, 2022 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its comprehensive genomic profiling offerings with xF+, a new non-invasive, liquid biopsy panel of 523 genes, focused on pathogenic mutations in cell-free DNA (cfDNA) (Press release, Tempus, JUN 3, 2022, View Source [SID1234615546]). The test will originally be available on a limited basis alongside xF, Tempus’ 105-gene liquid biopsy assay, with a broader launch slated for later this year.

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Tempus expects that the xF+ panel will be the largest clinically available liquid biopsy panel on the market, covering more genes with single nucleotide variants and indels reported in all genes, plus expanded coverage of translocations/gene rearrangements, and copy number variants. It can also measure blood-based tumor mutational burden (bTMB) and microsatellite instability (MSI), predictive biomarkers for response to various cancer immunotherapies. Liquid biopsies can be useful for parallel testing with tumor tissue to provide a more comprehensive detection of actionable alterations than tissue or liquid biopsy testing alone. Additionally, follow-up liquid biopsy testing can uncover new gene alterations and resistance mechanisms (clonal evolution), sample tumor DNA shed from metastatic sites, and can be used to longitudinally monitor disease burden and response to treatment.

"xF+ further strengthens Tempus’ range of genomic profiling capabilities, offering physicians a broad-panel liquid biopsy option for patients in which a comprehensive, non-invasive test is appropriate," said Nike Beaubier, MD, Vice President of Translational Medicine at Tempus. "We are excited to introduce what we believe is the largest clinically available liquid biopsy panel to provide even more insights on pathogenic mutations in cfDNA."

xF+ is the latest addition to Tempus’ library of assays, which includes xF; xT, an assay that analyzes 648 genes in solid tumor and hematologic malignancies; xG, a 52-gene panel that specifically identifies genetic variants associated with hereditary cancer syndromes and inherited risk of cancer; xG+, a 88-gene multi-cancer panel that covers genes associated with both common and rare hereditary cancer syndromes; and xE, an assay that analyzes the whole exome. All panels are run in Tempus’ CAP-accredited, CLIA-certified robotic sequencing labs.

On June 3, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the 2022 Jefferies Global Healthcare Conference on Friday, June 10, 2022 at 9:00 AM ET in New York, New York (Press release, Fate Therapeutics, JUN 3, 2022, View Source [SID1234615515]).

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A live webcast, if recorded, of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

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 Taiho Oncology, Inc. reorted updated results of the Phase 2 FOENIX-CCA2 trial of futibatinib, confirming results observed in an earlier analysis (Press release, Taiho, JUN 3, 2022, View Source [SID1234615547]). The trial was conducted in patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements including fusions . These data were presented as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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"Updated data from the pivotal FOENIX-CCA2 Phase 2 trial reinforce the durable efficacy and continued tolerability of futibatinib in previously treated patients with locally advanced or metastatic iCCA harboring FGFR2 gene rearrangements including fusions," said medical oncologist Lipika Goyal, MD, MPhil, of the Massachusetts General Hospital Cancer Center in Boston, and lead investigator on the study. "These data add to the body of evidence supporting futibatinib as a potential treatment option for patients living with this rare cancer that traditionally has had limited treatment options."

Each year, approximately 8,000 individuals in the U.S. are diagnosed with cholangiocarcinoma (CCA),1 a cancer of the bile ducts of the liver. Worldwide, approximately 0.3-6 people per 100,000 individuals live with CCA.2 CCA is mainly seen in people 65 years of age or older,3 and treatment options are limited. FGFR2 gene rearrangements, including gene fusions, which can form a hybrid gene and promote tumor proliferation, are observed more frequently in the iCCA patient population, with approximately 10-16% of patients having tumors with these rearrangements.4,5,6,7,8

The Phase 2 FOENIX-CCA2 trial included 103 patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy. Patients received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate (ORR) as assessed by independent central review.

At the time of the data cutoff for this updated analysis, with a median follow-up of 25.0 months, the ORR was 41.7%. Responses were durable, with a median duration of response (DoR) of 9.5 months (74% of responses lasted greater than six months). In addition, the disease control rate was 82.5%, median progression-free survival was 8.9 months and median overall survival was 20.0 months.

The most common treatment-related adverse events (TRAEs) were hyperphosphatemia (85%), alopecia (33%), dry mouth (30%), diarrhea (28%), dry skin (27%) and fatigue (25%). Most TRAEs were of mild or moderate intensity and manageable. There were two patients with grade 4 TRAEs and four patients discontinued treatment due to TRAEs. No treatment-related deaths occurred.

"Taiho Oncology remains committed to addressing unmet treatment needs in patients living with a broad range of cancers, and these data from the FOENIX-CCA2 trial demonstrate the clinical activity of futibatinib," said Volker Wacheck, Vice President, Clinical Development, Taiho Oncology, Inc. "We are looking forward to continued discussions with regulatory authorities around this important investigational therapy."

In March 2022, the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic CCA harboring FGFR2 gene rearrangements, including gene fusions. The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022. The FDA previously granted Breakthrough Therapy Designation (BTD) for futibatinib in CCA in February 2021.

About Futibatinib
Futibatinib (TAS-120) is an investigational, oral, potent, selective and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. This irreversible binding to the ATP binding pocket of FGFR1-4 results in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased cell death in tumors with FGFR1-4 genetic aberrations. Futibatinib is being studied alone as a potential treatment for patients with advanced solid tumors with FGFR1-4 genomic aberrations, including cholangiocarcinoma, or in combination with chemotherapy or other therapies.