On December 3, 2020 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib"), eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), and H3B-6545 (selective estrogen alpha receptor covalent antagonist), discovered at Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be given at the 43rd San Antonio Breast Cancer Symposium (SABCS2020) Virtual Meeting, from December 8 to 11, 2020, in San Antonio, Texas in the United States (Press release, Eisai, DEC 3, 2020, View Source [SID1234574976]).

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At this symposium, regarding the combination therapy with lenvatinib and the anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA) from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside of the United States and Canada), the results of the triple-negative breast cancer cohort in the basket-type Phase II clinical study (LEAP-005) for 6 types of previously treated, advanced solid tumors (Abstract No: PS12-07) is scheduled to be presented.

The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.

In addition, regarding H3B-6545, the results of evaluating tolerability, safety, and efficacy of Phase I/II clinical study for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (Abstract No: PD8-06) and others will be presented.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval

Major poster presentations at SABCS2020:
Product / Compound
Abstract No. Title / Scheduled Date and Time (local time: Central Standard Time)
Lenvatinib
PS12-07 Lenvatinib plus pembrolizumab for previously treated, advanced triple-negative breast cancer: Early results from the multicohort phase 2 LEAP-005 study
December 9 (Wed), 8:00 AM
Eribulin
PS13-37 Effectiveness of eribulin in poor prognosis subgroups of metastatic breast cancer (mBC) patients (Elderly, African Americans, and patients with liver metastases) in the United States
December 9 (Wed), 8:00 AM
H3B-6545
PD8-06 Phase I/II Trial of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer
December 10 (Thu), 2:15-3:30 PM
H3B-6545
PS12-15 Pharmacokinetics of H3B-6545 in Patients with Locally Advanced or Metastatic Estrogen Receptor-Positive HER2 Negative Breast Cancer
(ER+ and HER2- BC)
December 9 (Wed), 8:00 AM
H3B-6545
PS12-23 Development of H3B-6545, a first-in-class oral selective ER covalent antagonist (SERCA), for the treatment of ERaWT and ERaMUT breast cancer
December 9 (Wed), 8:00 AM

On December 3, 2020 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported that it will host a Virtual Lung Cancer R&D Day for investors and analysts on December 16, 2020, from 10:00 a.m. to 12:00 p.m. EST (Press release, Veracyte, DEC 3, 2020, View Source [SID1234572126]).

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The event will feature Veracyte senior management who will provide an overview of the company’s vision for transforming patient care in lung cancer, as well as leading pulmonologists who will discuss the challenges and opportunities in lung cancer diagnosis and treatment. Veracyte will also provide updates on its lung cancer product pipeline, including its Nasal Swab Test, for early diagnosis of lung cancer, and Percepta Atlas, for informing treatment decisions at the time of diagnosis. The company plans to launch both products in the second half of 2021.

A link to register for the event is available here and can also be accessed through Veracyte’s website at View Source A replay of the presentation will be available on the company’s website for approximately 90 days.

On December 3, 2020 The Multiple Myeloma Research Foundation (MMRF) and Dana-Farber Cancer Institute reported a pioneering research collaboration in smoldering myeloma (SMM), a precursor disease to multiple myeloma (Press release, Multiple Myeloma Research Foundation, DEC 3, 2020, View Source [SID1234572143]). Combining the strengths of the MMRF, a leader in multiple myeloma data generation, and Dana-Farber, a leader in SMM research, the initiative aims to revolutionize how SMM patients are treated. The ultimate goal is to identify markers of high-risk SMM and develop new treatment strategies that could delay or prevent progression to active multiple myeloma.

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"Recent research efforts driven by the MMRF and our partners have identified potential genomic and immune markers that may drive myeloma risk and progression," said Daniel Auclair, Ph.D., Chief Scientific Officer of the MMRF. "This collaboration with Dana-Farber will accelerate and enhance our knowledge of risk factors, allowing us to more precisely identify those patients at higher risk of progression to active disease, and laying the groundwork for future transformative, and possibly curative, clinical trials."

Through this MMRF-funded initiative, 500 SMM patients enrolled in Dana-Farber’s PROMISE or PCROWD studies will now have the opportunity to join the MMRF CureCloud study (View Source) and donate their blood samples and medical records. Dana-Farber initiated the PCROWD (View Source) and PROMISE (View Source) studies to actively screen for and study patients with myeloma precursor diseases to help define how disease progression occurs and develop therapies to prevent it. CureCloud is a first-of-its-kind, direct-to-patient research initiative to create a massive hub of genomic and clinical data in myeloma that includes a first-of-its-kind in-home genomic test using a liquid biopsy (blood sample), producing results that are returned directly to patients and their physicians.

Participating patients will have their myeloma DNA sequenced in the CureCloud’s MM-70 genomic sequencing test and share data from their electronic health records (EHR). Dr. Auclair will present the MM-70 liquid biopsy assay at this year’s virtual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. These data will be linked with each patient’s whole-genome and whole-exome sequencing data, circulating tumor cell data, and single-cell RNA sequencing data from both tumor and immune cells, forming the most complete picture of SMM ever assembled. All patient data will be de-identified and securely stored in the CureCloud database.

Currently, the rate of progression from SMM to multiple myeloma is 10% per year, but some patients have a higher risk of rapid progression based on risk factors such as the presence of certain genomic abnormalities. While the current standard of care for SMM is to "watch and wait" until patients progress before providing treatment, recent clinical trials show that treating high-risk SMM patients can result in an increased time to progression from SMM to active multiple myeloma, giving patients more time before developing symptoms.

"This revolutionary collaboration with the MMRF will enable us to build the most comprehensive data set for smoldering multiple myeloma," said Irene Ghobrial, MD, Director of the Clinical Investigator Research Program at Dana-Farber and a Principal Investigator of the PROMISE and PCROWD studies. "Additionally, patients who participate will receive their genomic test results, which may be helpful in determining their risk of progression to active myeloma and identifying future clinical trials."

The MMRF has led research efforts to identify genomic and immune markers of high-risk multiple myeloma via their CoMMpass Study, a longitudinal observational study which follows over 1,100 myeloma patients from diagnosis over at least eight years of their disease course, gathering molecular, immune, and clinical data. This study, which is among the largest genomics data sets of any cancer, has led to more than 100 peer-reviewed abstracts and publications. The MMRF and Dana-Farber have led more recent efforts in the area of myeloma prevention in collaboration with the Perelman Family Foundation and several leading myeloma academic centers, resulting in discoveries around genomic markers of risk in precursor conditions such as SMM and MGUS (Monoclonal Gammopathy of Undetermined Significance), as well as potentially even earlier genomic predictors such as CHIP (Clonal Hematopoiesis of Indeterminate Potential).

On December 3, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a webcast scheduled for investors to discuss the results from the NOPHO sponsored Phase 2 trial of eryaspase in ALL patients.

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The data will be presented by Dr. Line Stensig Lynggaard at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. On the webcast, Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, will comment on the data and be available for Q&A.

Oral Presentation Details (accessible only if registered for the ASH (Free ASH Whitepaper) annual meeting)

Abstract #467: NOR-GRASPALL 2016 (NCT03267030): Asparaginase encapsulated in Erythrocytes (eryaspase) – a promising alternative to PEG-asparaginase in case of hypersensitivity

The NOR-GRASPALL-2016 trial evaluated the safety and pharmacological profile of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase. The trial was conducted at 21 clinical sites in the Nordic and Baltic countries of Europe and enrolled 55 patients. The study findings will be featured as an oral presentation at ASH (Free ASH Whitepaper) by Dr. Line Stensig Lynggaard, representing NOPHO, on 6th December 2020 2.45pm PST/ 5.45pm EST / 11.45pm CET. Final results from this trial will be presented at the meeting.

The abstract can be found on-line at: View Source

Webcast Details

ERYTECH will hold a webcast on Monday, December 7, at 4:00 pm CET / 10:00am ET.

Dr. Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial, Dr. Iman El-Hariry, Chief Medical Officier of ERYTECH Pharma, and Gil Beyen, Chief Executive Officer of ERYTECH Pharma, will comment on the data and be available for Q&A.

The webcast can be followed live online via the link: View Source

Conference ID#: 2272914#

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options. (Press release, ERYtech Pharma, DEC 3, 2020, View Source [SID1234572128])

On December 3, 2020 Physicians’ Education Resource, LLC (PER), reported critical insights on practice-changing treatment strategies in hematology care as part of its Friday Satellite Symposia (FSS) at this year’s 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition on Dec. 4 (Press release, Physicians’ Education Resource, DEC 3, 2020, View Source [SID1234572144]).

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This program series will feature up to 15 continuing medical education (CME)-certified symposia sessions that delve into the evolving future of medicine and patient care-associated various specialties in hematology. The interactive virtual webcasts will explore evidence-based strategies, optimized testing approaches and the latest breakthrough treatment paradigms to improve patient care.

"For years, hematologists have joined PER for high-quality CME during the ASH (Free ASH Whitepaper) Friday Satellite Symposia, said Phil Talamo, president of PER. "This year, PER’s Friday Satellite Symposia will feature a discussion of new data and insights that will provide practical strategies that apply to the care of patients, presented by some of the world’s renowned expert faculty in hematology. We hope you’ll join us for this fully interactive, virtual educational event to get answers to your most challenging questions."

The PER FSS sessions include the following:

"Understanding Cold Agglutinin Disease: How Do Emerging Treatment Options Have the Potential to Transform Patient Outcomes?"
"Taking Action with Minimal Residual Disease: Technique, Role, and Utilization of MRD to Improve Outcomes in Patients with Hematologic Malignancies"
"Individualizing Treatment Plans and Optimizing Outcomes for Patients with MF and PV: Stories Behind The Science"
"The Evolving Role of PI3K Inhibitors for the Management of Hematologic Malignancies: Integration of Recent Data Sets Into Clinical Practice"
"D" is for Diagnosis: Detecting and Treating Rare Disorders in Hematologic Practice"
"Medical Crossfire: Exploring the Modern Management of Acute Lymphoblastic Leukemia from AYA to Adult"
"T-Cell Lymphoma Tumor Board: Application of Novel Agents for the Treatment of PTCL and CTCL"
"New Targets, New Data, New Guidelines: Assessing Treatment Options to Personalize Care in B-Cell Lymphomas"
"Medical Crossfire: Bridging Unmet Needs With Emerging Data in Relapsed/Refractory DLBCL to Improve Patient Outcomes"
"Sickle Cell Disease: Targeting Complications to Improve Long-Term Implications"
"Advances in CAR T-Cell Therapy: What Does the Future Look Like?"
"How to Do It Interactive Workshop: Taking Action With Clinical Advances in Chronic Lymphocytic Leukemia"
"Leveraging Clinical Data and Trials to Inform Treatment for Patients With GvHD: An Expert Case-Based Discussion"
"Improving Outcomes in MDS and MPN: Tailoring Treatment Based on Patient- and Disease-Specific Factors"
"State of the Art Care in Relapsed/Refractory Multiple Myeloma: Novel Targets, Combinations, and Treatment Approaches"
Throughout these programs, the top minds in hematology and hematology/oncology will provide valuable expertise and perspective on a variety of hematology-focused topics. In addition, learners will have the ability to submit questions and participate in expert discussions via PER’s custom, interactive platform, along with VIP-level access to network with key opinion leaders for a more private discussion.