A Case-Based Exploration of Current and Future Directions in Myelofibrosis — Where We Are, Where We’re Going

Join us on Friday, December 11^th from 3:15 PM to 5:15 PM central time (4:15 PM to 6:15 PM eastern time).

Module 1: Current Clinical Decision-Making for Myelofibrosis (MF) in the Absence of Severe Cytopenias

• Appropriate threshold for initiating active therapy for MF; published data supporting early intervention versus observation for patients with intermediate- and high-risk disease
• Factors in the selection of initial therapy for patients with MF without severe cytopenias
• Published research database supporting the use of ruxolitinib for patients with intermediate- and high-risk MF; impact of ruxolitinib on symptom control and survival
• Initial dosing and dose-modification strategies with ruxolitinib
• Key efficacy and safety findings with fedratinib for patients with JAK inhibitor-naïve MF and those resistant or intolerant to ruxolitinib; selection of patients for treatment with fedratinib
• Spectrum, frequency and severity of common and unique toxicities associated with ruxolitinib and fedratinib; optimal approach to monitoring for and managing treatment-related adverse events

Module 2: Managing MF in Patients with Anemia

•  Incidence of MF-associated anemia; differences between momelotinib and other approved JAK inhibitors and rationale for the activity of momelotinib in patients with anemia
• Key findings from the Phase III MOMENTUM study evaluating momelotinib versus danazol for anemic patients with symptomatic MF who had previously received a JAK inhibitor
• Efficacy and safety of momelotinib compared to ruxolitinib in the subset of JAK inhibitor-naïve patients with severe anemia in the Phase III SIMPLIFY-1 trial
• FDA approval of momelotinib for patients with MF and disease-related anemia; current role in disease management
• Comparative tolerability/toxicity profile of momelotinib and other approved JAK inhibitors
• Retrospective analysis of the PERSIST-2 study to evaluate the utility of pacritinib for patients with MF and severe anemia

Module 3: Managing MF in Patients with Thrombocytopenia

• Incidence of thrombocytopenia in patients with newly diagnosed MF and in those with prior JAK inhibitor exposure
• Mechanistic similarities and differences between pacritinib and other approved JAK inhibitors; implications for the safety of pacritinib in patients with low platelet counts
• Published clinical research findings with pacritinib for MF, including among patients with baseline thrombocytopenia
• FDA approval of pacritinib for patients with MF and severe thrombocytopenia; optimal use in clinical practice
• Design, entry criteria and key endpoints of the ongoing confirmatory Phase III PACIFICA trial evaluating pacritinib versus physician’s choice of therapy for patients with MF and severe thrombocytopenia; estimated completion date
• Incidence and severity of treatment-related adverse events reported with pacritinib, including hemorrhage and cardiovascular events; optimal approach to monitoring and management

Module 4: Novel Approaches for MF Potentially Nearing the Clinic

• Mechanism of action of luspatercept; biological rationale for its investigation for MF-associated anemia
• Emerging outcomes from the Phase III INDEPENDENCE study evaluating luspatercept with concomitant JAK inhibitor therapy for patients with MF-associated anemia receiving red blood cell transfusions; implications for research and clinical practice
• Current clinical role, if any, of luspatercept for patients with MF experiencing anemia; preliminary insights from ongoing studies, such as ODYSSEY, attempting to further elucidate the potential utility of luspatercept
• Mechanism of the antitumor activity of selinexor and the biological rationale for its evaluation as treatment for MF
• Available early-phase research findings with selinexor monotherapy and selinexor/ruxolitinib for patients with JAK inhibitor-naïve and JAK inhibitor-pretreated MF
• Published findings from the Phase III SENTRY study assessing selinexor combined with ruxolitinib for JAK inhibitor-naïve MF; potential role of this strategy
• Scientific rationale for investigating imetelstat for MF; mechanism of action of this drug
• Key findings from early studies, such as IMbark and IMproveMF, assessing imetelstat as monotherapy or in combination with ruxolitinib for MF
• Design, eligibility criteria and primary and secondary endpoints of the Phase III IMpactMF study comparing imetelstat to best available therapy for relapsed/refractory (R/R) MF; implications of its discontinuation

Module 5: Other Promising Novel Agents Under Investigation for MF

• Mechanism of the antitumor activity of navtemadlin; key efficacy and safety findings from the Phase III BOREAS trial evaluating navtemadlin monotherapy for patients with MF that was resistant or refractory to JAK inhibitors
• Ongoing Phase III POIESIS study of navtemadlin/ruxolitinib for patients with JAK inhibitor-naïve MF who have a suboptimal response to ruxolitinib monotherapy
• Scientific rationale for targeting the PIM1 kinase in MF; mechanism of action of nuvisertib
• Preliminary efficacy and safety findings with nuvisertib as monotherapy or in combination with a JAK inhibitor for R/R MF; ongoing assessment of nuvisertib with ruxolitinib or momelotinib
• Rationale for the inhibition of BET proteins in MF; mechanism of action of pelabresib
• Key efficacy and safety findings from the Phase III MANIFEST-2 study combining pelabresib with ruxolitinib for JAK inhibitor-naïve MF; ongoing Phase III MANIFEST-3 trial of that combination in a more symptomatic population
• Early data with mutant CALR-directed monoclonal antibodies, such as INCA033989, and ongoing evaluation of bispecific antibodies, such as INCA035784, for MF
• Other promising investigational agents and strategies, such as mutant JAK2V617F-specific inhibitors, for patients with MF

Target Audience
This activity is intended for hematologists, medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of myelofibrosis (MF).

Learning Objectives
At the conclusion of this activity, participants should be able to

• Use an understanding of disease biology and natural history to effectively counsel patients diagnosed with MF regarding their long-term prognosis.
• Analyze how age, performance status and other biological and disease-related factors affect the decision to initiate therapy and the subsequent selection of treatment for patients with primary and secondary MF.
• Appraise available research informing the safety and efficacy of approved JAK inhibitors for patients with MF, including those with anemia and/or thrombocytopenia, and personalize treatment recommendations based on this information.
• Evaluate published research findings with JAK inhibitors alone and in combination with other novel therapies for patients with MF and anemia to optimize decision-making for this population.
• Review available research data with and the current clinical role of novel JAK inhibitors for patients with MF and severe thrombocytopenia.
• Understand the biological rationale for the inhibition of exportin 1 (XPO1) in patients with MF, and reflect on available research findings with XPO1 inhibitors in combination with JAK inhibition as front-line treatment.
• Recall available research findings with combination regimens incorporating JAK inhibitors and other novel investigational agents, such as BET inhibitors and MDM2 inhibitors, and consider the potential role of these emerging approaches.
• Recognize the spectrum, frequency and severity of side effects associated with JAK inhibitors and other therapies employed in the treatment of MF, and implement a plan of care to recognize, prevent and manage resultant toxicities.
• Assess the mechanisms of action of, available research findings with and ongoing investigation of other novel agents for MF, and consider the potential clinical application of these approaches.

CE Credit
CME credit information will be provided to each participant at the conclusion of the activity.

Accreditation Statement
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement
Research To Practice designates this live activity for a maximum of 2 AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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Unlabeled/Unapproved Uses Notice
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the provider or grantors.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships will have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations. Faculty disclosures to be announced.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Masarova — Advisory Committees: Cogent Biosciences, Karyopharm Therapeutics, PharmaEssentia. Dr Mesa — Consulting Agreements: Bristol Myers Squibb, Genentech, a member of the Roche Group, Geron Corporation, GSK, Incyte Corporation, Lilly, PharmaEssentia, Sobi, Takeda Pharmaceuticals USA Inc, Telios Pharma Inc; Contracted Research: Incyte Corporation, PharmaEssentia; Data and Safety Monitoring Boards/Committees: Geron Corporation, Kartos Therapeutics, Telios Pharma Inc. Dr Passamonti — Advisory Committees: AbbVie Inc, Bristol Myers Squibb, GSK, Kartos Therapeutics, Karyopharm Therapeutics, Menarini Group, Novartis, Roche Laboratories Inc, Stemline Therapeutics Inc, Sumitomo Pharma, Takeda Pharmaceutical Company Limited; Data and Safety Monitoring Boards/Committees: Menarini Group (myeloma study); Speakers Bureaus: AOP Orphan Pharmaceuticals GmbH, Bristol Myers Squibb, GSK, Incyte Corporation, Menarini Group, Novartis, Stemline Therapeutics Inc. Dr Rampal — Consulting Agreements: AbbVie Inc, Blueprint Medicines, Bristol Myers Squibb, Cogent Biosciences, CTI BioPharma, a Sobi Company, Disc Medicine, Galecto Inc, GSK, Incyte Corporation, Jazz Pharmaceuticals Inc, Kartos Therapeutics, Karyopharm Therapeutics, MorphoSys, Novartis, Opna Bio, PharmaEssentia, Roche Laboratories Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Zentalis Pharmaceuticals; Contracted Research: BioMed Valley Discoveries, Incyte Corporation, MorphoSys, Ryvu Therapeutics, Stemline Therapeutics Inc, Zentalis Pharmaceuticals; Data and Safety Monitoring Boards/Committees: Merck.

MODERATOR
Dr Kuykendall — Consulting Agreements: AbbVie Inc, Agios Pharmaceuticals Inc, Blueprint Medicines, Bristol Myers Squibb, Celgene Corporation, Cogent Biosciences, CTI BioPharma, a Sobi Company, Deciphera Pharmaceuticals Inc, Disc Medicine, Geron Corporation, GSK, Incyte Corporation, Karyopharm Therapeutics, Merck, Novartis, Ono Pharmaceutical Co Ltd, Opna Bio, PharmaEssentia, Protagonist Therapeutics Inc, Silence Therapeutics, Takeda Pharmaceuticals USA Inc; Contracted Research: Ajax Therapeutics, Blueprint Medicines, Bristol Myers Squibb, Geron Corporation, GSK, Janssen Biotech Inc, Kartos Therapeutics, Novartis, Protagonist Therapeutics Inc. 

Research To Practice CME Planning Committee Members, Staff and Reviewers
Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

Supporters
This activity is supported by educational grants from Bristol Myers Squibb, Geron Corporation, GSK, Incyte Corporation, Karyopharm Therapeutics, and Novartis.

Sheraton New Orleans Hotel
500 Canal Street
New Orleans, LA 70130
Hotel Phone: (504) 525-2500

Meeting Room
Napoleon Ballroom C/D — Third floor

Directions
The Sheraton New Orleans Hotel is located 0.9 miles (15-minute walk) from the New Orleans Ernest N Morial Convention Center, where the 2026 ASH Annual Meeting is taking place.

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