On November 1, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that three oral and four poster presentations detailing clinical and preclinical data will be featured at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting will be held December 1-4, 2018 in San Diego, California (Press release, Fate Therapeutics, NOV 1, 2018, View Source [SID1234530540]).

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iPSC Product Platform

The Company’s iPSC product platform will be highlighted in two oral presentations and three poster presentations. An oral presentation will highlight new preclinical data of FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. Using an in vitro three-dimensional tumor spheroid model, the Company demonstrated that FT500, in combination with activated T cells and an anti-PD1 antibody, led to near complete elimination of target cells (>99% reduction) as compared to FT500 or activated T cells alone. A second oral presentation will highlight in vitro proof-of-concept data demonstrating the anti-tumor activity of iPSC-derived, receptor-engineered NK cells in combination with tumor-specific engager molecules, such as a NKG2C/IL15/CD33 tri-specific killer engager. Additional off-the-shelf cell product candidates, including the Company’s first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT519) product candidates, will be featured in poster presentations.

FATE-NK100

An oral presentation will describe a next-generation, GMP-compliant protocol established by Dr. Karl-Johan Malmberg for production of adaptive memory NK cells having homogeneous expression of a single inhibitory killer cell immunoglobulin-like receptor (KIR). Notably, the NK cells also lack expression of the HLA-E binding inhibitory receptor NKG2A, which is a dominant NK cell immune checkpoint receptor. The approach, which was developed under the Company’s research collaboration with Oslo University Hospital, enables highly-specific, adaptive memory NK cells to be robustly expanded ex vivo for administration to KIR-mismatched patients to maximize anti-tumor potency.

ProTmune

The Company will present new clinical data from the Phase 1 PROTECT study of ProTmune, the Company’s next-generation hematopoietic cell graft for patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Key clinical outcomes, including disease-free survival and freedom from chronic graft-versus-host disease (GvHD), cancer relapse, and death at one-year following HCT, from the seven subjects receiving ProTmune in the Phase 1 clinical trial will be featured in a poster presentation.

2018 ASH (Free ASH Whitepaper) Oral Presentations

FT500 iPSC-Derived NK Cell Cancer Immunotherapy
Title: iPSC-Derived NK Cells and Anti-PD1 Antibody Synergize to Enhance T-Cell Cytokine and Cytolytic Responses Against Multiple Tumors
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 730
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:30 PM
Location: San Diego Convention Center, Room 8
iPSC Product Platform
Title: iPSC-Derived NK Cells Genetically Modified to Express NKG2C/DAP12 Mediate Potent Function When Targeted through an NKG2C/IL15/CD33 Tri-Specific Killer Engager (TriKE)
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 729
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:15 PM
Location: San Diego Convention Center, Room 8
Adaptive Memory NK Cells
Title: Efficient Scale-up and Preclinical Evaluation of NKG2C+ Adaptive NK Cell Expansion for Therapy Against High-risk AML/MDS
Last Author: Karl-Johan Malmberg, MD, PhD, Group Leader, Department of Cancer Immunology, Oslo University Hospital
Publication Number: 195
Session: 711. Cell Collection and Processing II
Date and Time: Saturday, December 1, 2018, 2:30 PM
Location: Manchester Grand Hyatt San Diego, Grand Hall A
2018 ASH (Free ASH Whitepaper) Poster Presentations

FT819 iPSC-derived CAR T-Cell Cancer Immunotherapy
Title: Pluripotent Cell-Derived Off-the-Shelf TCR-Less CAR-Targeted Cytotoxic T Cell Therapeutic for the Allogeneic Treatment of B Cell Malignancies
Last Author: Bob Valamehr, PhD, Chief Development Officer, Fate Therapeutics
Publication Number: 4546
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT519 iPSC-derived CAR NK Cell Cancer Immunotherapy
Title: Off-the-Shelf Natural Killer Cells with Multi-Functional Engineering Using a Novel Anti-CD19 Chimeric Antigen Receptor Combined with Stabilized CD16 and IL15 Expression to Enhance Directed Anti-Tumor Activity
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Publication Number: 4541
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT538 iPSC-derived hnCD16, CD38-null NK Cell Cancer Immunotherapy
Title: CD38 Deficient, CD16 Engineered NK Cells Exhibit Enhanced Antibody Dependent Cellular Cytotoxicity without NK Cell Fratricide to Augment Anti-Myeloma Immunity in Combination with Daratumumab
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 3224
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
Date and Time: Sunday, December 2, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
ProTmune
Title: ProTmune, a Next-Generation Graft for GvHD Prophylaxis in Allogeneic Hematopoietic Cell Transplantation: 1-Year Safety and Efficacy Phase 1 Data
First Author: Richard Maziarz, MD, Principal Investigator, Oregon Health Sciences University
Session: 732. Clinical Allogeneic Transplantation: Results
Publication Number: 2167
Date and Time: Saturday, December 1, 2018, 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH
About ProTmune
ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

On November 1, 2018 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that eight abstracts have been selected for presentation, including one oral presentation, at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting being held December 1-4, 2018, in San Diego (Press release, Verastem, NOV 1, 2018, View Source;p=irol-newsArticle&ID=2374805 [SID1234530539]).

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"At ASH (Free ASH Whitepaper) this year, we look forward to the presentation of a wealth of data highlighting further results from the duvelisib development programs," said Hagop Youssoufian, MSc, MD, Head of Medical Strategy at Verastem Oncology. "The breadth of data to be presented at the meeting reflects our commitment to addressing the clinical needs of patients with hematologic malignancies by advancing the science behind PI3K-delta and PI3K-gamma inhibition, underscoring our dedication to develop practice-changing medicines that improve outcomes for patients."

Details for the ASH (Free ASH Whitepaper) 2018 presentations are as follows:

Oral Presentation

Title: The combination of Duvelisib, a PI3K-δ,γ Inhibitor, and Romidepsin is highly active in relapsed/refractory peripheral T-cell lymphoma with low rates of transaminitis: Results of a multicenter, multi-arm phase 1 study with expansion cohorts
Presenter: Steven Horwitz, Memorial Sloan Kettering Cancer Center and NYC Health + Hospitals/Bellevue
Abstract Number/Publication ID: 683
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Immunotherapy and Targeted Strategies
Date and Time: Monday, December 3, 2018; 11:30 AM PT
Location: San Diego Convention Center, Room 6F

Poster Presentations

Title: Clinical and Biological Indicators of Duvelisib Efficacy in CLL from the Phase 3 DUO Study
Presenter: Jennifer Brown, Harvard Medical School and Dana-Farber Cancer Institute
Abstract Number/Publication ID: 1856
Session: 642. CLL: Therapy, excluding Transplantation: Poster I
Date and Time: Saturday, December 1, 2018; 6:15-8:15 PM PT
Location: San Diego Convention Center, Hall GH

Title: The Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL: Updated Results from the DUO Crossover Extension Study
Presenter: Matthew Davids, Dana-Farber Cancer Institute
Abstract Number/Publication ID: 3140
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 2, 2018; 6:00-8:00 PM PT
Location: San Diego Convention Center, Hall GH

Title: Characterization of the Long-Term Efficacy and Safety of Duvelisib Monotherapy in Patients with Relapsed/Refractory CLL/SLL on Treatment for > 2 Years across 4 Clinical Studies
Presenter: Ian Flinn, Sarah Cannon Research Institute
Abstract Number/Publication ID: 3146
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 2, 2018; 6:00-8:00 PM PT
Location: San Diego Convention Center, Hall GH

Title: Simultaneous inhibition of BCL-2 and PI3K signaling overcomes ibrutinib resistance in mantle cell lymphoma
Presenter: Haige Ye, MD Anderson Cancer Center
Abstract Number/Publication ID: 2950
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
Date and Time: Sunday, December 2, 2018; 6:00-8:00 PM PT
Location: San Diego Convention Center, Hall GH

Title: Prognostic and Immune-Related Factors for Response to Duvelisib in the Phase 2 DYNAMO Clinical Trial in iNHL
Presenter: Pier Luigi Zinzani, University of Bologna Institute of Hematology
Abstract Number/Publication ID: 4167
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 3, 2018; 6:00-8:00 PM PT
Location: San Diego Convention Center, Hall GH

Title: Dual Inhibition of PI3K-δ and PI3K-γ by Duvelisib Impairs CLL B Cells and CLL-Supporting Cells and Overcomes Ibrutinib Resistance in a Patient-Derived Xenograft Model
Presenter: Shih-Shih Chen, The Feinstein Institute for Medical Research, Northwell Health
Abstract Number/Publication ID: 4420
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 3, 2018; 6:00-8:00 PM PT
Location: San Diego Convention Center, Hall GH

Title: Dynamic BH3 Profiling Predicts Patient Response and MRD Status in Chronic Lymphocytic Leukemia (CLL) Patients Undergoing Frontline Treatment with Kinase Inhibitor Augmented (KIA) FCR
Presenter: Timothy Z. Lehmberg, Dana-Farber Cancer Institute
Abstract Number/Publication ID: 4395
Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster III
Date and Time: Monday, December 3, 2018; 6:00 – 8:00 PM PT
Location: San Diego Convention Center, Hall GH

On November 1, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK cells, macrophages and T cells), reported that six abstracts highlighting data from the Company’s innate immune cell and T cell-based therapeutic programs have been accepted for presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 1-4, 2018 in San Diego, CA (Press release, Affimed, NOV 1, 2018, View Source [SID1234530538]).

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Presentations related to Affimed’s CD16A innate immune cells engager programs include 6-month follow-up data from the clinical study of AFM13, Affimed’s lead CD30/CD16A bispecific ROCK antibody, in combination with Merck’s Keytruda (pembrolizumab), interim data from Columbia University on AFM13 in relapsed or refractory CD30-positive lymphoma with cutaneous manifestation including translational data, and preclinical data from The University of Texas MD Anderson Cancer Center on cord blood-derived allogeneic NK cells in combination with AFM13. Additional abstracts on CD16A engagers include updates on the Company’s research on the role of AFM13 activating CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data supporting further development of Affimed’s partnered ROCK-based development candidate AFM26 (BCMA/CD16A) as a promising treatment for patients with multiple myeloma.

Preliminary results, including clinical activity and safety, from a dose escalation trial in relapsed/refractory acute lymphoblastic leukemia for AFM11, Affimed’s CD19 targeting T cell engager, will also be presented.

Full abstracts of the presentations can be accessed on the ASH (Free ASH Whitepaper) website at View Source Details for ASH (Free ASH Whitepaper) presentations are as follows:

Oral Presentation

Abstract: Cord Blood Derived Natural Killer Cells Loaded with a Tetravalent Bispecific Antibody Construct (AFM13) As Off-the-Shelf Cell Therapy for CD30+ Malignancies

Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Immunologic approaches

Date and Time: Sunday, December 2, 2018 9:30 AM – 11:00 AM

Location: San Diego Convention Center, Room 28D

Poster Presentations

Abstract: A Phase 1b Study Investigating the Combination of the Tetravalent Bispecific NK Cell Engager AFM13 and Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)

Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma-Clinical Studies: Poster II

Date and Time: Sunday, December 2, 2018 6:00 PM – 8:00 PM

Location: San Diego Convention Center, Hall GH

Abstract: CD16A-Specific Tetravalent Bispecific Immune Cell Engagers Potently Induce Antibody-Dependent Cellular Phagocytosis (ADCP) on Macrophages

Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: Preclinical Characterization of AFM26, a Novel B Cell Maturation Antigen (BCMA)-Directed Tetravalent Bispecific Antibody for High Affinity Retargeting of NK Cells Against Myeloma

Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I

Date and Time: Saturday, December 1, 2018 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Abstract: A Phase 1 Study Investigating AFM11 in Patients with Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia: Preliminary Results

Session: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Poster III

Date and Time: Monday, December 3, 2018 6:00 PM – 8:00 PM

Location: San Diego Convention Center, Hall GH

On November 1, 2018 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the first patient has been dosed in a Phase 2 study evaluating its novel, targeted cancer immunotherapy, BN-Brachyury, and radiation in patients with advanced chordoma (Press release, Bavarian Nordic, NOV 1, 2018, View Source [SID1234530537]).

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Chordoma is a rare cancer that occurs in the bones of the skull base and spine, resulting in approximately 1,000 new cases being diagnosed in the United States and Europe annually. The brachyury protein has been shown to be universally overexpressed in chordoma tumors, while not being found in most normal tissue. The presence of brachyury in epithelial solid tumors has been highly correlated with metastatic disease, multi-drug resistance and decreased survival rates. BN-Brachyury’s prime-boost vaccination regimen has been optimized to include the gene for brachyury, as well as costimulatory molecules (TRICOM) known to increase immune activation. Prior data suggests that BN-Brachyury can safely target brachyury and induce brachyury-specific T-cell immune responses.

"While upfront surgical resection or definitive radiation can result in cure for some patients, we know that the majority of patients with this disease are not cured. Those who are not cured will almost all go on to have advanced disease, for which there are no therapeutic options known to result in defined clinical benefit," said Chris Heery, M.D., the Chief Medical Officer of Bavarian Nordic and member of the Medical Advisory Board of the Chordoma Foundation. "The almost universal expression of brachyury in chordoma makes it a prime candidate for our targeted immunotherapy. The initiation of the Phase 2 study serves as a significant step in the evaluation of BN-Brachyury as an effective treatment for patients with this rare disease."

The Phase 2, multiple-site trial will assess the effectiveness of BN-Brachyury and radiation therapy in patients with advanced chordoma. The study is expected to enroll up to 29 patients, in a two-stage design. If the threshold of activity is reached in stage 1, the study will proceed to stage 2 and full enrollment. Patients will be administered a primer of the highly attenuated, non-replicating vaccinia virus MVA-BN-Brachyury, followed by a booster of the recombinant fowlpox virus FPV-Brachyury and radiation therapy. The study aims to determine if the combination therapy results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone.

"For more than a decade, we have supported patients and research centers across the United States and Europe in their quest to find and develop better treatment options for this devastating cancer," said Josh Sommer, Founder and Executive Director of the Chordoma Foundation. "Although there has been a dramatic increase in chordoma research over the years, the rarity and complexity of the disease has left it relatively underserved. Bavarian Nordic’s cancer immunotherapy, BN-Brachyury, is a welcome, needed and promising advancement in the treatment of patients with advanced chordomas."

In May 2018, the FDA granted orphan drug designation to BN-Brachyury for the treatment of chordoma. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

For more information on trial, please visit: View Source

About BN-Brachyury
BN-Brachyury is a novel prime-boost cancer immunotherapy candidate, developed in collaboration with the National Cancer Institute (NCI). The product candidate consists of two different vaccine components; MVA-BN and fowlpox or FPV, which have been modified to express brachyury and to encode three costimulatory molecules, known as TRICOM. Brachyury is a tumor-associated antigen that is overexpressed in major solid tumor indications, as well as several rare, ultra-orphan cancer indications, and is reported to play a key role in the metastasis and progression of tumors. Tumors that overexpress brachyury are believed to be highly resistant to standard therapies, including radiation and chemotherapy, and are associated with decreased survival rates.

On November 1, 2018 Incyte (Nasdaq:INCY) reported that multiple abstracts, including data from its clinical development programs for ruxolitinib (Jakafi), pemigatinib and INCB50465 will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2018 in San Diego, California, from December 1-4, 2018 (Press release, Incyte, NOV 1, 2018, View Source [SID1234530536]).

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Key data presented at ASH (Free ASH Whitepaper) 2018 will include results from the pivotal REACH1 trial evaluating ruxolitinib in combination with corticosteroids for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids, which have been accepted for oral presentation. Additionally, new data from the Phase 2 study evaluating INCB50465 in combination with ruxolitinib in patients with myelofibrosis (MF) and initial data from the Phase 2 fight-203 study evaluating pemigatinib in patients with myeloproliferative neoplasms (MPNs) with activating FGFR1 translocations have been accepted for oral presentation.

"We are looking forward to highlighting our later-stage, targeted therapy portfolio at this year’s ASH (Free ASH Whitepaper) Annual Meeting," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Specifically, we are pleased to present results from our REACH1 study, which formed the basis of our supplemental new drug application for ruxolitinib as a treatment for acute GVHD that is currently under Priority Review by the FDA, and new data from our INCB50465 and pemigatinib clinical development programs, which further underscore our leadership in MPNs."

Key abstract presentations include:

Ruxolitinib (Jakafi)

Oral Presentations

Safety and Efficacy of Combined Ruxolitinib and Thalidomide in Patients with Myelofibrosis: Initial Results of a Phase 2 Study (Abstract #354)

Sunday, December 2, 2018, 9:30-11:00 a.m., Manchester Grand Hyatt, Seaport Ballroom F, Oral Session 634, Myeloproliferative Syndromes: Clinical: Addressing Areas of Unmet Need in Prognostic Assessments and Therapy for MPNs
Results from REACH1, a Single-arm Phase 2 Study of Ruxolitinib in Combination with Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (Abstract #601)

Monday, December 3, 2018, 7:00-8:30 a.m., Manchester Grand Hyatt, Grand Hall A, Oral Session 722, Clinical Allogeneic Transplantation: Acute and Chronic GVHD
A Phase 2 Study of Ruxolitinib with Chemotherapy in Children with Philadelphia Chromosome-like Acute Lymphoblastic Leukemia (INCB18424-269/AALL1521): Dose-Finding Results from the Part 1 Safety Phase (Abstract #555)

Monday, December 3, 2018, 7:00-8:30 a.m., San Diego Convention Center, Ballroom 20A, Oral Session 614, Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Targeted Therapy in ALL: Immunotherapy and Beyond
RUXOPEG, a Multi-Center Bayesian Phase ½ Adaptive Randomized Trial of the Combination of Ruxolitinib and Pegylated Interferon Alpha 2a in Patients with Myeloproliferative Neoplasms-Associated Myelofibrosis*(Abstract #581)

Monday, December 3, 2018, 7:00-8:30 a.m., Manchester Grand Hyatt, Grand Hall D, Oral Session 634, Myeloproliferative Syndromes: Clinical: Interferon Therapy and Mutational Analysis in the MPNs
Poster Sessions

Updated Results from An Open-Label, Multicenter, Expanded Treatment Protocol (ETP) Phase (Ph) 3b Study Of Ruxolitinib (Rux) In Patients (Pts) With Polycythemia Vera (PV) Who Are Hydroxyurea (HU) Resistant Or Intolerant And For Whom No Alternative Treatments Are Available (Abstract #1774)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Characteristics Associated with Hydroxyurea Treatment Change in Patients with Polycythemia Vera: An Analysis from the REVEAL Study (Abstract #1770)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Real-World Risk Assessment and Treatment of Patients with Myelofibrosis at Community Oncology Practices in the United States(Abstract #1765)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Impact of Myeloproliferative Neoplasms on Patients’ Employment and Income: Findings from the Living with MPN Survey(Abstract #2250)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 902, Health Services Research – Malignant Diseases: Poster I
Elevated White Blood Cell levels and Thrombotic Events in Patients with Polycythemia Vera: A Real-World Analysis of Veterans Health Administration Data (Abstract #1758)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Correlation between MPN-SAF TSS and EORTC QLQ-C30 Scores in Patients with PV: Data from the REVEAL Study (Abstract #2259)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 902, Health Services Research – Malignant Diseases: Poster I
Long-term Efficacy and Safety (5 Years) in RESPONSE, a Phase 3 Study Comparing Ruxolitinib (rux) With Best Available Therapy (BAT) in Hydroxyurea (HU)-resistant/intolerant Patients (pts) With Polycythemia Vera (PV)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Ruxolitinib for the Treatment of Inadequately Controlled Polycythemia Vera Without Splenomegaly: 156-Week Follow-Up From the Phase 3 RESPONSE-2 Study (Abstract #1754)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster I
Disease and Clinical Characteristics of Patients with Essential Thrombocythemia Enrolled in the MOST Study (Abstract #4306)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster III
Disease Characteristics of Minority Patient Populations with Polycythemia Vera: An Analysis from the REVEAL Study (Abstract #4735)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 902, Health Services Research – Malignant Diseases: Poster III
Real-World Management of Myelofibrosis with Ruxolitinib: Initial Analysis of an Italian Observational Study (ROMEI) (Abstract #4312)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 634, Myeloproliferative Syndromes: Clinical: Poster III
Impact of Myeloproliferative Neoplasms (MPNs) on Health-Related Quality of Life (HRQOL) and Medical Resource Utilization: Results from the MERGE Registry (Abstract #4311)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 634: Myeloproliferative Syndromes: Clinical: Poster III
INCB50465 (PI3Kδ)

Oral Presentation

A Phase 2 Study of the Safety and Efficacy of INCB050465, a Selective PI3Kδ Inhibitor, in Combination with Ruxolitinib in Patients with Myelofibrosis (Abstract #353)

Sunday, December 2, 2018, 9:30-11:00 a.m., Manchester Grand Hyatt, Seaport Ballroom F, Oral Session 634, Myeloproliferative Syndromes: Clinical: Addressing Areas of Unmet Need in Prognostic Assessments and Therapy for MPNs
Poster Session

Cell-of-Origin Subtype Prediction of Diffuse Large B-cell Lymphoma Using Gene Expression and Proteomic Data (Abstract #1712)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 627, Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies: Poster I
Pemigatinib (INCB054828)

Oral Presentation

Interim Results from fight-203, a Phase 2, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Pemigatinib (INCB054828) in Patients with Myeloid/Lymphoid Neoplasms with Rearrangement of Fibroblast Growth Factor Receptor 1 (FGFR1) (Abstract #690)

Monday, December 3, 2018, 10:30-12:00 p.m., Manchester Grand Hyatt, Grand Hall A, Oral Session 634, Myeloproliferative Syndromes: Clinical: Emerging Therapies and Prognostic Scoring in Myelofibrosis and Other MPNs
Itacitinib

Plasma Biomarker Association with Response in Acute GVHD Subjects Treated With the Combination of Itacitinib and Corticosteroids in a Phase 1 Clinical Trial (Abstract #4559)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 722, Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Ponatinib

Efficacy and Safety of Ponatinib in CML and Ph+ ALL Patients in Real World Clinical Practice – Data from a Belgian Registry (Abstract #1744)

Saturday, December 1, 2018, 6:15-8:15 p.m., San Diego Convention Center, Hall GH, Poster Session 632, Chronic Myeloid Leukemia: Therapy: Poster I
Preclinical

The Persistent Survival of MPN Cells to JAK2 Inhibition is Dependent on SHP2 Activity, Which May Provide a Therapeutic Target to Enhance Current Anti-MPN Therapies (Abstract #3064)

Sunday, December 2, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 635, Myeloproliferative Syndromes: Basic Science: Poster II
Itacitinib, a JAK1 Selective Inhibitor Preserves Graft-versus-Leukemia (GVL), Enhances Survival and is Highly Efficacious in a MHC-mismatched Mouse Model of Acute GvHD (Abstract #4522)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 701, Experimental Transplantation: Basic Biology, Pre-Clinical Models Poster III
Ruxolitinib, a JAK1/JAK2 Selective Inhibitor is Highly Efficacious in Corticosteroid Untreated and Refractory MHC-mismatched Mouse Model of Acute GvHD (Abstract 4523)

Monday, December 3, 2018, 6:00-8:00 p.m., San Diego Convention Center, Hall GH, Poster Session 701, Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster III
Full session details and data presentation listings for ASH (Free ASH Whitepaper) 2018 can be found at: View Source

About Jakafi(ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States. Ruxolitinib is also being evaluated in patients with acute and chronic GVHD who have an inadequate response to corticosteroids in the REACH2 and REACH3 clinical studies, respectively. It is expected that these two pivotal studies will complete in 2019, and could support additional regulatory submissions, in the U.S. by Incyte and ex-U.S. by Novartis, in 2020.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.