On November 4, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that two abstracts related to the Company’s selective PTEFb/CDK9 inhibitor, VIP152, program have been accepted for presentation at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 11-14, 2021 in Atlanta, GA (Press release, Vincerx Pharma, NOV 4, 2021, View Source [SID1234594364]). The following abstracts were published today and are now available on the ASH (Free ASH Whitepaper) website at www.hematology.org.

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VIP152, a selective CDK9 inhibitor, induces complete regression of high-grade B-cell lymphoma (HGBL) models and depletion of short-lived oncogenic driver transcripts, MYC and MCL1, with a once weekly schedule. (Abstract #1192)

Session Name: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms

Date: Saturday, December 11, 2021

Time: Poster viewing 9:00am-7:30pm; presenters available 5:30-7:30pm ET

Location: Hall B5

VIP152 Is a Novel CDK9 Inhibitor with Efficacy in Chronic Lymphocytic Leukemia (Abstract #270)

Session Name: Chemical Biology and Experimental Therapeutics

Date: Saturday, December 11, 2021

Time: Oral Presentation at 3:15 ET

Location: Georgia World Congress Center, C108-C109

On November 4, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint pathway, reported the Company will be presenting early clinical data from ASPEN-02, its ongoing Phase 1/2 study evaluating evorpacept in combination with azacitidine for the treatment of myelodysplastic syndromes ("MDS") in a poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting held December 11-14, 2021 in Atlanta, Georgia (Press release, ALX Oncology, NOV 4, 2021, View Source [SID1234594363]).

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Key Abstract Data

As of July 15, 2021, 13 subjects with newly diagnosed ("ND") higher risk or relapsed/refractory ("R/R") MDS were enrolled into phase 1 cohorts receiving escalating doses of evorpacept (20 mg/kg Q2W, 30 mg/kg Q2W, and 60 mg/kg Q4W) combined with standard doses of azacitidine. Of the 7 ND subjects, 4 had therapy-related MDS, and 5 had TP53 mutation with complex cytogenetics. Of the 6 R/R subjects, all had received at least one hypomethylating agent-based regimen.

Among the 5 ND subjects evaluable for response (all with TP53 mutation), there were 2 subjects with cytogenetic response who met criteria for complete response ("CR") subsequent to the date of this abstract, 1 subject with a best response of marrow complete response ("mCR") with hematologic improvement ("HI"), and 1 subject each with stable disease ("SD") and progressive disease ("PD"). Of the 4 ND subjects who were transfusion dependent at baseline, 2 achieved transfusion independence. Among the 5 R/R subjects evaluable for response, there were 2 subjects with a best response of mCR, 2 with SD, and 1 with PD. No dose-limiting toxicities were observed in any cohort and no maximum tolerated dose was reached. Additional results will be presented at the conference.

Poster Presentation Details

Title: Evorpacept (ALX148), a CD47-Blocking Myeloid Checkpoint Inhibitor, in Combination with Azacitidine: A Phase 1/2 Study in Patients with Myelodysplastic Syndrome (ASPEN-02)

Session Name: 637. Myelodysplastic Syndromes – Clinical and Epidemiological: Poster II

Presentation Date and Location: December 12, 2021, 6:00pm – 8:00pm ET, Georgia World Congress Center, Hall B5

Publication Number: 2601

On November 4, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that clinical data for HM43239, a myeloid kinome inhibitor in-licensed by Aptose (announced separately today – link) is being presented in an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held Saturday, December 11 – Monday, December 14, 2021 in Atlanta, GA and virtually (Press release, Aptose Biosciences, NOV 4, 2021, View Source [SID1234594362]). In addition, clinical data for luxeptinib, a dual lymphoid and myeloid inhibitor, and for APTO-253, a small molecule MYC oncogene repressor, have been accepted for poster presentation.

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The abstracts accepted for presentation are listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the presentations will include additional data not found in the abstracts. Aptose also will be holding an investor event during the ASH (Free ASH Whitepaper) timeframe to provide up-to-date data. Details will be forthcoming.

Oral Presentation Details

Publication #702: First in Human FLT3 and SYK Inhibitor HM43239 Shows Single Agent Activity in Patients with Relapsed or Refractory FLT3 Mutated and Wild-Type Acute Myeloid Leukemia (AML)
Oral Presentation Session Date & Time: Monday, December 13, 2021, 4:00 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies
Location: Georgia World Congress Center, Georgia Ballroom 1-3

Poster Presentation Details

Publication #1355: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic BTK/FLT3 Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory B-Cell Malignancies
Poster Session Date & Time: Saturday, December 11, 2021, 5:30 – 7:30 PM ET
Session Name: 623. Mantle Cell, Follicular, and other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Location: Georgia World Congress Center, Hall B5

Publication #1272: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic FLT3/BTK Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Poster Session Date & Time: Saturday, December 11, 2021, 5:30 – 7:30 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Location: Georgia World Congress Center, Hall B5

Publication #3411: A Phase 1 a/b Dose Escalation Study of the MYC Repressor Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS
Poster Session Date & Time: Monday, December 13, 2021, 6:00 – 8:00 PM ET
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Location: Georgia World Congress Center, Hall B5

The poster abstracts also will be published in the November supplemental issue of Blood, an ASH (Free ASH Whitepaper) journal, available online.

On November 4, 2021 bluebird bio, Inc. (Nasdaq: BLUE) reported that new data from its lentiviral vector (LVV) gene addition programs for patients with β-thalassemia (beta-thal) who require regular red blood cell (RBC) transfusions and sickle cell disease will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 11-14, 2021, at the Georgia World Congress Center in Atlanta, Georgia, and virtually (Press release, bluebird bio, NOV 4, 2021, View Source [SID1234594360]).

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bluebird bio will present updated efficacy and safety results from its clinical programs, including long-term follow-up results of betibeglogene autotemcel (beti-cel) that demonstrate iron level stabilization in adult and pediatric patients living with beta-thal who require regular RBC transfusions followed for up to seven years; the oral presentation will also be featured in the ASH (Free ASH Whitepaper) press program. Additional beti-cel data include improvement in health-related quality of life among adult and pediatric patients in the HGB-207 and HGB-212 Phase 3 studies.

Updated results from the Phase 1/2 HGB-206 study of LentiGlobin for sickle cell disease gene therapy (bb1111) will also be presented, including new analyses demonstrating improvements in clinical and biologic outcomes, as well as updated and longer-term data from HGB-206 Group C that show sustained improvements in quality of life.

β-Thalassemia Data
Oral Presentation [#573]: Restoring Iron Homeostasis in Patients who Achieved Transfusion Independence After Treatment with Betibeglogene Autotemcel Gene Therapy: Results from up to 7 Years of Follow-up
Presenting Author: Alexis A. Thompson, MD, MPH, Hematology Section Head, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL
Date/Time: Monday, December 13, 2021, 11:00 am ET

Poster [#3085]: Improvement in Health-Related Quality of Life Following Treatment with Betibeglogene Autotemcel in Patients with Transfusion-Dependent β-Thalassemia Enrolled in Phase 3 Studies
Presenting Author: Janet L. Kwiatkowski, MD, MSCE, Director, Thalassemia Center at Children’s Hospital of Philadelphia, Philadelphia, PA
Date/Time: Monday, December 13, 2021, 6:00 – 8:00 pm ET

Sickle Cell Disease Data
Oral Presentation [#7]: Sustained Improvements in Patient Reported Quality of Life up to 24 Months Post-treatment with LentiGlobin for Sickle Cell Disease (bb1111) Gene Therapy
Presenting Author: Mark C. Walters, MD, Medical Director, Jordan Family Center for BMT & Cellular Therapies Research, UCSF Benioff Children’s Hospital Oakland, Oakland, CA
Date/Time: Saturday, December 11, 2021, 9:30 am ET

Oral Presentation [#561]: Polyclonality Strongly Correlates with Biological Outcomes and is Significantly Increased Following Improvements to the Phase 1/2 HGB-206 Protocol and Manufacturing of LentiGlobin for Sickle Cell Disease (SCD; bb1111) Gene Therapy
Presenting Author: John F. Tisdale, MD, Chief, Cellular and Molecular Therapeutics Branch, NHLBI, Bethesda, MD
Date/Time: Sunday, December 12, 2021, 5:00 pm ET

Poster [#3093]: Severe Acute Complications of Sickle Cell Disease in two Expert Referral Centers (UK and Italy): Natural History Studies Highlight Ongoing Unmet Need for Effective Disease Modifying or Curative Therapies
Presenting Author: Raffaella Colombatti, MD, PhD, Pediatric Hematologist, University of Padova, Padua, Italy
Date/Time: Monday, December 13, 2021, 6:00 – 8:00 pm ET

Abstracts outlining bluebird bio’s accepted data at ASH (Free ASH Whitepaper) are available on the ASH (Free ASH Whitepaper) conference website.

About betibeglogene autotemcel (beti-cel)
betibeglogene autotemcel (beti-cel) (pronounced beh TEE cell) is a one-time gene therapy custom-designed to treat the underlying cause of beta-thalassemia in patients who require regular transfusions. In order to correct the deficiency of adult hemoglobin that is the hallmark of beta-thalassemia, beti-cel adds functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic (blood) stem cells (HSCs). Once a patient has the βA-T87Q-globin gene, they have the potential to produce HbAT87Q, which is beti-cel-derived adult hemoglobin (Hb) at levels that may eliminate or significantly reduce the need for transfusions. In beti-cel studies, transfusion independence (TI) is defined as no longer needing RBC transfusions for at least 12 months while maintaining a weighted average Hb of at least 9 g/dL. Across Phase 3 studies, 89% (32/36) of evaluable patients across ages and genotypes, including pediatric patients as young as four years of age and those with the most severe β0/β0 genotypes, achieved TI.

beti-cel is manufactured using the BB305 lentiviral vector (LVV), a third-generation, self-inactivating LVV that has been studied for more than a decade.

Adverse reactions considered related to beti-cel were uncommon and consisted primarily of infusion-related reactions (abdominal pain, hot flush, dyspnea, tachycardia and non-cardiac chest pain) and cytopenias (thrombocytopenia, leukopenia and neutropenia). Pain in extremity shortly after treatment was also documented. One of these adverse events (AE) was a serious adverse event (SAE) of thrombocytopenia considered possibly related to beti-cel.

The majority of AEs and SAEs unrelated to beti-cel were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan (including several SAEs of veno-occlusive disease). The Phase 3 Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies evaluating beti-cel are ongoing; enrollment is complete, and all patients have been treated. bluebird bio is also conducting a long-term follow-up study, LTF-303, to monitor safety and efficacy for people who have participated in bluebird bio-sponsored beti-cel clinical studies through 15 years, post treatment with beti-cel.

A biologics license application (BLA) for beti-cel has been submitted to the FDA.

About LentiGlobin for sickle cell disease (bb1111)
LentiGlobin gene therapy for sickle cell disease (bb1111) is an investigational one-time treatment being studied for sickle cell disease, that is designed to add functional copies of a modified form of the β-globin gene (βA-T87Q-globin gene) into a patient’s own hematopoietic (blood) stem cells (HSCs). Once patients have the βA-T87Q-globin gene, their red blood cells can produce anti-sickling hemoglobin (HbAT87Q) that decreases the proportion of HbS, with the goal of reducing sickled red blood cells, hemolysis and other complications. bluebird bio’s clinical development program for LentiGlobin for sickle cell disease includes the completed Phase 1/2 HGB-205 and ongoing Phase 1/2 HGB-206 and Phase 3 HGB-210 studies. bluebird bio is also conducting a long-term safety and efficacy follow-up study (LTF-307) for people who have participated in bluebird bio sponsored clinical studies of LentiGlobin for sickle cell disease.

As of February 17, 2021, a total of 49 patients have been treated with LentiGlobin for SCD, with up to 6 years of patient follow-up, in the HGB-205 (n=3), HGB-206 (n=44) and HGB-210 (n=2) clinical studies. The HGB-206 total includes: Group A (n=7), B (n=2) and C (n=35), representing progressive adaptations to the treatment and manufacturing processes. In the Group C cohort of the Phase 1/2 HGB-206 study of LentiGlobin for sickle cell disease, no severe vaso-occlusive events (VOEs) were reported with up to 24 months of follow-up in patients with a history of at least four severe VOEs and at least six months of follow-up.

The safety data profile remains generally consistent with the risks of autologous stem cell transplantation and myeloablative single-agent busulfan conditioning, as well as underlying SCD.

In the Group C cohort of the HGB-206 study, one patient with underlying cardiopulmonary disease and SCD-related complications died 20 months post-treatment; the treating physician and an independent monitoring committee agreed his death was unlikely related to LentiGlobin for SCD.

In the initial cohort (Group A) of the HGB-206 study, two patients treated with LentiGlobin for SCD developed acute myeloid leukemia (AML). After thorough investigations into the cases, bluebird bio determined that these were unlikely related to the insertion of bluebird’s lentiviral vector (LVV) gene therapy for SCD.

For more information on LentiGlobin for SCD studies, visit: View Source or clinicaltrials.gov.

The FDA has granted orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for sickle cell disease.

LentiGlobin for sickle cell disease is investigational and has not been approved in any geography.

On November 4, 2021 Incyte (Nasdaq:INCY) reported that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and virtually (Press release, Incyte, NOV 4, 2021, View Source [SID1234594359]).

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"We are excited for the opportunity to present, along with our partners, more than 35 abstracts and share progress from Incyte’s oncology portfolio at this year’s ASH (Free ASH Whitepaper) meeting," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "The oral presentations, including new data from the CITADEL program evaluating parsaclisib in three types of lymphoma as well as results from the RE-MIND2 study of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma, highlight the strength of our robust oncology portfolio and underscore our commitment to addressing urgent medical needs for people with cancer."

Select key abstract presentations from Incyte-developed and partnered programs include:

Oral Presentations

Parsaclisib

Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma: Primary Analysis from a Phase 2 Study (CITADEL-204) (Abstract #44. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy in Low Grade Lymphoma. Saturday, December 11, 9:45 a.m. ET)

Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated With a BTK Inhibitor: Primary Analysis From a Phase 2 Study (CITADEL-205) (Abstract #382. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Front-line Induction Therapy and Novel Agents After Relapse. Sunday, December 12, 10:15 a.m. ET)

Efficacy and Safety of Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma: Primary Analysis From a Phase 2 Study (CITADEL-203) (Abstract #813. Session: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Front-line Induction Therapy and Novel Agents After Relapse. Monday, December 13, 5:00 p.m. ET)

Pemigatinib: Myeloproliferative Neoplasms (MPN)

A Phase 2 Study of Pemigatinib (FIGHT-203; INCB054828) in Patients with Myeloid/Lymphoid Neoplasms (MLNs) with Fibroblast Growth Factor Receptor 1 (FGFR1) Rearrangement (MLNFGFR1) (Abstract #385. Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Novel Therapies for MPNs and JAK Inhibitors for Myelofibrosis. Sunday, December 12, 9:30 a.m. ET)

Ponatinib

Post hoc Analysis of Responses to Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) by Baseline BCR-ABL1 level and Baseline Mutation Status in the OPTIC Trial1 (Abstract #307. Session:#623. Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of Resistance and Expanded Therapies. Saturday, December 11, 4:00 p.m. ET)

Ruxolitinib: Graft-Versus-Host Disease (GVHD)

Validation of Amphiregulin as a Monitoring Biomarker During Treatment of Life-Threatening Acute GVHD: A Secondary Analysis of 2 Prospective Clinical Trials (Abstract #259. Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Treatment of Acute and Chronic Graft vs. Host Disease. Saturday, December 11, 2:00 p.m. ET)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

The Interaction Between IPSS Score and JAK2 Mutation Identifies Patients at Different Vascular Risk in Primary Myelofibrosis2 (Abstract #236. Session: #634. Myeloproliferative Syndromes: Clinical and Epidemiological: Risk Stratification and Prognostication. Saturday, December 11, 2:15 p.m. ET)

A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera (Analysis of Data from the REVEAL Study)(Abstract #239. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Risk Stratification and Prognostication. Saturday, December 11, 3:00 p.m. ET)

Tafasitamab

Tafasitamab Plus Lenalidomide Versus pola‑BR, R2, and CAR-T: Comparison of Outcomes from RE-MIND2, an Observational Retrospective Cohort Study in Relapsed or Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #183. Session:905. Outcomes Research-Lymphoid Malignancies: Lymphoma/CLL Real-World Data. Saturday, December 11, 12:30 p.m. ET)

Poster Presentations

All accepted posters in Poster I are available from 9:00 a.m. – 7:30 p.m. ET on Saturday, December 11. All accepted posters in Poster II sessions are available from 9:00 a.m. – 8:00 p.m. ET on Sunday, December 12. All accepted posters in Poster III sessions are available from 9:00 a.m. – 8:00 p.m. ET on Monday, December 13.

INCB000928: Myeloproliferative Neoplasms (MPN)

A Phase 1/2, Open-label, Multicenter Study of INCB000928 Monotherapy in Patients with Anemia due to Myelodysplastic Syndromes or Multiple Myeloma (Abstract #3707. Session:637. Myelodysplastic Syndromes — Clinical and Epidemiological: Poster III. Monday, December 13)

INCB057643: Myeloproliferative Neoplasms (MPN)

A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB 57643-103) (Abstract #2574. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 12)

Parsaclisib

A Phase 2, Multicenter, Single-arm, Open-Label study of Parsaclisib, a PI3Kδ inhibitor, in Relapsed or Refractory Follicular Lymphoma in China4 (Abstract #3536. Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III. Monday, December 13)

Ponatinib

Dose Modification Dynamics of Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and OPTIC Trials1(Abstract #2550. Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II. Sunday, December 12)

Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Primary Analysis of the OITI Trial (Abstract #3603. Session:632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III. Monday, December 13)

Ruxolitinib: GVHD

Disability Associated with Chronic Graft-Versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation (Abstract #4060. Session:904. Outcomes Research—Non-Malignant Conditions: Poster III. Monday, December 13)

Update of Multicenter, Retrospective Evaluation of Overall Response and Failure Free Survival Following Ruxolitinib Therapy for Heavily Pre-Treated Chronic GVHD Patients with Steroid-Failure: A Proposal of Risk Score Model for Failure-Free Survival2(Abstract #3905. Session: #722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III. Monday, December 13)

Patient-Reported Outcomes (PROs) Among Patients with Steroid-Refractory or Dependent Chronic Graft-vs-Host Disease (cGVHD) Randomized to Ruxolitinib (RUX) vs Best Available Therapy (BAT)2(Abstract #3909. Session:Session: #722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III. Monday, December 13)

Ruxolitinib: Myeloproliferative Neoplasms (MPN)

Does Early Intervention in Myelofibrosis Impact Outcomes? A Pooled Analysis of the COMFORT I and II Studies (Abstract #1505. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

Community Versus Academic Practice in Essential Thrombocythemia and Myelofibrosis: Differences in Clinical Characteristics, Diagnosis, Treatment Patterns, and Symptom Burden (Analysis of Data from the MOST Study) (Abstract #1497. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

ADORE: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis2(Abstract #1489. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

Characteristics of High-Risk Polycythemia Vera Patients with Suboptimal Response to First-Line Therapy who Switched to Ruxolitinib vs. Those who did not Switch: Findings from PV-SWITCH, a Multinational, Retrospective Chart Review Study2(Abstract #3646. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Labor Market Attachment in Patients with Myeloproliferative Neoplasms: A Nationwide Matched Cohort Study2(Abstract #3627. Session:#634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Ruxolitinib + Parsaclisib Combination Studies: Myeloproliferative Neoplasms (MPN)

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Add-On Parsaclisib in Patients with Myelofibrosis who have Suboptimal Response to Ruxolitinib (Abstract #1502. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster I. Saturday, December 11)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ruxolitinib plus Parsaclisib in Patients With JAK- and PI3K-Inhibitor Treatment–Naive Myelofibrosis (Abstract #2579. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II. Sunday, December 12)

Subgroup Analysis from a Phase 2 Study of the Efficacy and Safety of Parsaclisib, a Selective PI3Kδ Inhibitor, in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) (Abstract #3647. Session:634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Monday, December 13)

Tafasitamab

inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular or Marginal Zone Lymphoma (Abstract #2421. Session:623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II. Sunday, December 12)

Preferences and Perceptions Regarding Treatment Decision-Making for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)3 (Abstract #1928. Session:902. Health Services Research—Lymphoid Malignancies: Poster I. Saturday, December 11)

The Impact of Prior Treatment with a CD19 Targeting Monoclonal Antibody on Subsequent Treatment with CD19 Targeting CART Cell Therapy in Preclinical Models3(Abstract #2412. Session:622. Lymphomas: Translational—Non-Genetic: Poster II. Sunday, December 12)

The SUMOylation Inhibitor TAK-981 in Combination with the CD19-Targeting Antibody Tafasitamab Shows Enhanced Anti-Tumor Activity in Preclinical B-Cell Lymphoma Models3(Abstract #2268. Session:605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II. Sunday, December 12)

First-MIND: A Phase Ib, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R‑CHOP in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma3(Abstract #3556. Session:626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster III. Monday, December 13)

Full abstracts will be available on ASH (Free ASH Whitepaper)’s website and in a special online-only issue of Blood, ASH (Free ASH Whitepaper)’s official journal. More information regarding ASH (Free ASH Whitepaper) 2021 can be found on ASH (Free ASH Whitepaper)’s website: View Source

About Jakafi (ruxolitinib)

Jakafi (ruxolitinib) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF, for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.

About Monjuvi (tafasitamab-cxix)

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

About Ponatinib (Iclusig) Tablets

Ponatinib (Iclusig) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.