On November 18, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported positive topline results from the global pivotal QuANTUM-First phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, NOV 18, 2021, View Source [SID1234595816]).1

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QuANTUM-First met its primary endpoint, demonstrating that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile.

AML is one of the most common forms of leukemia in adults, representing about one-third of all cases.2 The five-year survival rate of AML is about 29%, and patients with FLT3-ITD positive AML have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1,3 There remains a high unmet need to improve survival for the majority of patients with AML.4

"The results of the phase 3 QuANTUM-First trial showed that adding quizartinib, a potent and selective FLT3 inhibitor, to chemotherapy significantly prolonged overall survival in patients with newly diagnosed FLT3-ITD positive AML," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "We look forward to sharing the QuANTUM-First data with the hematology community and will initiate discussions with global regulatory authorities."

Data from QuANTUM-First will be presented at an upcoming medical meeting and shared with regulatory authorities globally.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 – 75) with newly diagnosed FLT3-ITD positive AML.

Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation regimens. Eligible patients, including those who underwent allogenic hematopoietic stem cell transplant (HSCT), continued with single agent quizartinib or placebo for up to 36 cycles.

The primary study endpoint is OS. Secondary endpoints include event-free survival (EFS), post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, were also evaluated.

QuANTUM-First enrolled 539 patients at approximately 200 study sites worldwide including in Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia (AML)

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.5 AML is one of the most common types of leukemia in adults, representing about one-third of all cases.2 A heterogenous blood cancer, AML is characterized by a five-year survival rate of about 29%, the lowest by far among the major leukemia subtypes.6,7

Treatment guidelines for patients with newly diagnosed AML recommend a cytarabine-based chemotherapy regimen with or without a targeted therapy as determined by the presence of genetic mutations, age and other factors.8 Patients with newly diagnosed FLT3 mutated AML may receive a FLT3 inhibitor as part of their initial treatment regimen and/or subsequent regimens.8 While intensive chemotherapy and/or HSCT can improve chances for sustained remission in eligible patients, a substantial proportion of patients are not suitable for either intervention, and cure rates are particularly low for older patients.1,6 In recent years, new targeted treatments have increased options and improved outcomes for some patients with molecularly defined AML subtypes.6

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a transmembrane receptor tyrosine kinase protein normally expressed by hematopoietic stem cells; FLT3 plays an important role in cell development by promoting cell survival, growth and differentiation through various signaling pathways.1 Mutations of the FLT3 gene, which occur in approximately 30% of patients with AML, can drive oncogenic signaling.1 The most common type of FLT3 mutation is the FLT3-ITD (internal tandem duplication), which is present in about 25% of all AML patients and contributes to cancer cell proliferation.1 Patients with FLT3-ITD mutations have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1

About Quizartinib

Quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, is in phase 1/2 clinical development in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America.1 Several phase 1/2 combination studies with quizartinib are also underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

Quizartinib is currently approved for use in Japan under the brand name VANFLYTA for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

About Daiichi Sankyo Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

On November 18, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management will participate in the 33rd Annual Piper Sandler Virtual Healthcare Conference on Wednesday, December 1, 2021 (Press release, Personalis, NOV 18, 2021, View Source [SID1234595815]).

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Interested parties may access the pre-recorded and archived webcast of the presentation for 90 days following the conference through the "Events" section of Personalis’ website at View Source

On November 18, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference (Press release, Gilead Sciences, NOV 18, 2021, View Source [SID1234595814]):

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Evercore ISI Annual HealthCONx Conference on Thursday, December 2 at 2:40pm ET

The live webcast can be accessed at the company’s investors page at investors.gilead.com. The replay will be available for at least 30 days following the presentation.

On November 18, 2021 Immunomic Therapeutics, Inc. (‘ITI’), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that Kristen Batich, MD, Ph.D. and a team from Duke University School of Medicine will present clinical data at the 2021 Society for Neurology (SNO) Annual Meeting being held in Boston, MA, November 18-21st, 2021 (Press release, Immunomic Therapeutics, NOV 18, 2021, View Source [SID1234595813]).

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The data to be presented at the SNO meeting are from three sequential clinical trials utilizing Cytomegalovirus (CMV)–specific dendritic cell vaccines that encode the chimeric CMV protein LAMP-pp65 in patients with primary Glioblastoma. The patients were given serial vaccination through adjuvant temozolomide cycles. The Phase II ATTAC study (NCT00639639) led to an expanded cohort trial (ATTAC-GM: NCT00693639) resulting in positive immunologic and clinical response. The larger confirmatory trial, ELEVATE (NCT02366728), revealed significantly longer overall survival (OS) in patients randomized to LAMP pp65 RNA loaded DC vaccines combined with tetanus-diphtheria booster. The results demonstrate that a CMV pp65-LAMP RNA-pulsed dendritic cell vaccination was associated with positive immunologic and clinical response in patients with glioblastoma (GBM).

"The clinical data to be presented demonstrates the potential impact of our UNITE technology platform, powered by LAMP, and will help validate our therapeutic approach utilizing vaccines to treat difficult cancers like glioblastoma," said Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics, Inc. "We are encouraged by the immunological response shown with this patient group and we look forward to Dr. Batich’s presentation of these positive findings at the SNO meeting."

Abstract Session: Clinical Trials I

Title: Reproducibility of clinical trials using CMV-targeted dendritic cell vaccines in patients with glioblastoma
Category: CTIM-10
Date and Time: Friday, November 19, 2021 4:45 PM – 4:50 PM EST
Location: Ballroom C, Hynes Convention Center, Boston, MA

Presenter:

Kristen A. Batich, MD, PhD
Duke University Medical Center
Durham, United States

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improve survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP-1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On November 18, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the presentation of a multi-institutional case series showing that its CNSide cerebrospinal fluid assay helps physicians monitor treatment response and detects actionable mutations in patients with metastatic breast cancer and leptomeningeal disease (LMD) (Press release, Biocept, NOV 18, 2021, View Source [SID1234595812]). The poster will be presented virtually at the Society for Neuro-Oncology Annual Meeting in Boston, Nov. 19, 2021, from 7:30-9:30 p.m. ET, and Biocept will be exhibiting at booth #303.

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Breast cancer is one of the most common cancers associated with LMD, a devastating complication in which cancer spreads to the membrane surrounding the brain and spinal cord. The current standard of care for diagnosing LMD is through clinical evaluation, imaging and cytology, which have limited sensitivity. Median survival after a diagnosis of LMD is just two to three months.

The case series included four breast cancer patients, ages 32 to 57, with suspected LMD who were treated at four different institutions. CNSide and cytology were used in parallel to detect tumor cells in the cerebrospinal fluid at diagnosis and throughout treatment. CNSide was also used to determine tumor cell counts and the presence of HER2 amplification to help guide therapy. At diagnosis, CNSide detected cancer cells in three of three patients, compared with two of three patients for cytology. (The fourth patient was diagnosed before CNSide was available.) CNSide detected CSF tumor cells in all eleven measurements taken, compared to six of eleven using cytology. Throughout treatment, CNSide showed a decrease in CSF tumor cells in all four patients, ranging from 99.7% to 100%, corresponding with an improved clinical response.

"Having a quantitative assay that provides tumor cell counts, rather than just a positive or negative result, is a major advance in the management of patients with leptomeningeal disease," said Priya Kumthekar, M.D., Neuro-Oncologist and Associate Professor of Neurology at Northwestern Medicine’s Feinberg School of Medicine, who will present the case series poster. "A positive cytology result may suggest that the patient is not responding to treatment, which could lead to therapy being stopped or changed. As this case series shows, CNSide’s quantitative results may show that, in fact, the tumor cell count has dropped dramatically, indicating that the patient is responding, and therapy should be continued."

"These cases illustrate the value of CNSide in treatment response monitoring and identification of targets for therapy that can produce a sustained response in leptomeningeal disease," said Michael Dugan, M.D., Chief Medical Officer and Medical Director of Biocept. "CNSide has the potential to allow clinicians to have more confidence in their treatment decisions, improving the clinical management of leptomeningeal disease in a way that may help patients see improvement in symptoms and live significantly longer lives."

The case series was completed by neuro-oncologists from Smilow Cancer Hospital at Yale New Haven Health, Lou and Jean Malnati Brain Tumor Institute at Northwestern Medicine, UT Southwestern Medical Center and Barrow Neurological Institute. The abstract (#BIOM-05), titled "Case Series of Multi-Institutional Utility of CNSide to Manage Leptomeningeal Disease in Patients with Metastatic Breast Cancer," can be accessed here.