oncology and hematology

Guest: Caron A. Jacobson, MD

CD19-directed chimeric antigen receptor (CAR) T-cell therapies are revolutionizing the treatment of aggressive non-Hodgkin lymphoma (NHL), offering patients with refractory/relapsed disease the chance for a potential cure after a single infusion. However, the widespread use of CAR T-cell therapies faces several challenges, from the production of the therapies to the management of toxicities to issues of inpatient vs outpatient administration. While CAR T-cell therapies have historically been given in the inpatient setting, interest in outpatient delivery is growing, and this option may become more feasible if logistical issues and lack of multidisciplinary collaboration between the community provider and the CAR-T cell therapy center can be overcome.

AXIS routinely collects and analyzes data gathered from participants in our live activities. These questions provide incredible insight regarding the persistent challenges that clinicians face when trying to optimize treatment and management of patients with cancer, helping to verify where clinical practice gaps exist. This activity will provide expert answers to questions asked during a recent educational series on CAR T-cell therapies in large B-cell lymphoma regarding practical considerations for CAR T-cell therapies.

Host: Charles Turck, PharmD, BCPS, BCCCP
Guest: Gil Melmed, MD, MS

The inflammation biosimilar development process uses a stepwise approach with increasing certainty to generate the totality of evidence, which demonstrates the safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed.^1,2 Dive further into the role of totality of evidence in the inflammation biosimilar development and approval process with Dr. Gil Melmed, Director of Inflammatory Bowel Disease Clinical Research at the Cedars-Sinai and Professor of Medicine at Cedars-Sinai and at the David Geffen School of Medicine at University of California, Los Angeles. Dr. Melmed was compensated for participating in this program.

References:

1. US Food and Drug Administration. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for Industry. Published online April 2015. Accessed March 22, 2023. https://www.fda.gov/media/135612/download

2. US Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product Guidance for Industry. Published online April 2015. Accessed March 22, 2023. https://www.fda.gov/media/82647/download

©2023 Amgen Inc. All rights reserved. USA-CBU-81605 5/23

Host: Paul P. Doghramji, MD, FAAFP
Guest: Rami Komrokji, MD
Guest: Allan Platt, PA-C, MMSc

Low-risk myelodysplastic syndrome (LR-MDS) is an acquired bone marrow disorder that manifests with symptomatic anemia. Many patients become dependent on red blood cell transfusions. Erythropoiesis-stimulating agents (ESAs) are the first-line treatment, but not all patients with LR-MDS respond to ESAs, and many become refractory to ESAs over time. Although advances have been made in the treatment of anemia in patients with MDS, there remains a significant unmet need for new and better treatment options for patients with ESA-refractory, transfusion-dependent MDS.

Timely identification of patients who become ESA refractory is critical for primary care physicians to promptly request referral to hematology specialists. Delays in referral can contribute to increased disease burden and lower quality of life (QoL) for patients. To achieve optimal patient outcomes requires multi-disciplinary team-based management and collaboration among primary care and hematology specialty care providers. With recent FDA approvals and emerging positive trial data, the multi-disciplinary care teams are faced with learning how to integrate new treatment options and associated guidelines into real-world clinical practice thus making clinical decision-making much more complex.

This educational activity, featuring an expert panel discussion, will review the identification of ESA failure in patients with LR-MDS and the importance of timely referral to …

Host: Mark Socinski, MD

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Cem Akin, MD, PhD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Deepti Radia, MD

Non-advanced systemic mastocytosis (nonAdvSM) is poorly understood and likely often overlooked or misdiagnosed. Multiple issues complicate the accurate differential diagnosis of nonAdvSM subtypes. Recent updates for diagnostic criteria, as well as validated assessments and a greater understanding of laboratory findings for this population, are providing practitioners with additional tools for arriving at an accurate diagnosis. Although many therapeutics exist for addressing symptoms of nonAdvSM, those treatments are purely palliative. To date, no disease-modifying drugs have been FDA-approved for treating nonAdvSM. However, therapeutics that are already approved for advanced SM or other indications are being evaluated in the nonAdvSM space. These drugs, particularly KIT inhibitors, have the potential to improve patient outcomes for nonAdvSM. Healthcare providers are in a unique position to improve patient outcomes by becoming experts in diagnosing, assessing, and monitoring patients with nonAdvSM; as well as ensuring access to the latest, most effective treatments. To that end, there is a need to increase disease state awareness and close knowledge gaps around the diagnosis and management of this rare disease.

Host: Anthony Mato, MD, MSCE
Guest: Toby A. Eyre, MD, MBChB
Guest: Talha Munir, PhD

The validation of targeted agent classes, driven by the emergence of BTK inhibitors as a highly effective therapeutic tool, has transformed the medical management of CLL/SLL and led to similar advances for other B-cell malignancies. Although this transformation has substantially improved outcomes, challenges remain and are centered on the problem of devising truly individualized sequential care in the relapsed/refractory disease setting, where outcomes to date have not improved as dramatically as those for newly diagnosed/treatment-naïve disease. Therapeutic intolerance and challenges involving adverse event management, BTK inhibitor resistance, and double-refractory status contribute to therapy interruption or discontinuation and abrogate clinical benefits associated with continued BTK inhibitor therapy, leading to subsequent care that is suboptimal due to a dearth of effective treatment options.

The educational activity, featuring an expert panel discussion comprised of 1 US and 2 international faculty thought leaders, will provide an evaluation of the most recent clinical data and expert insights on the current and emerging evidence supporting the clinical utility of BTK inhibitors in relapsed/refractory CLL/SLL.

Host: Richard S. Finn, MD

Evidence supports the notion that adding targeted agents that have a different mechanism of action than those that cause estrogen receptor interference can improve the benefits and outcomes seen with endocrine therapies alone in HR+/HER2- metastatic breast cancer (mBC). Clinical trial and real-world evidence show that CDK 4/6 inhibitors are safe and effective treatments for HR+/HER2- mBC. Real-world evidence can supplement clinical trial evidence and be more applicable to relevant community-based populations and clinical practice settings.

Optimal care of mBC involves the use of effective therapies that are supported by the latest evidence and guidelines, selected through a shared decision-making process, and individualized to each patient’s needs. The educational Oncology Clinic features an up-to-date review of real-world evidence surrounding CDK 4/6 inhibitors in mBC that expands on available clinical trial evidence. Through case vignettes that model best practices in shared decision-making, expert faculty will demonstrate how to translate clinical trial and real-world evidence into discussions with patients.