Haematological Malignancies, Haematology CE/CME ACCREDITED Watch Time: 34 mins

touchTALKS What’s on the horizon for higher-risk MDS? An update on emerging novel agents

Dr David Sallman reviews advances in HR-MDS management, including the mode of action and latest clinical data for emerging treatments.

 
Video Chapters
Novel treatments for HR-MDS: What’s on the horizon?

Dr David Sallman describes updates to the classification of HR-MDS and outlines the mode of action of emerging treatments.

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Efficacy data for emerging treatments for patients with HR-MDS

Dr David Sallman discusses the latest clinical trials and efficacy data for emerging treatments for HR-MDS.

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Safety data for emerging treatments for patients with HR-MDS

Dr David Sallman summarizes the safety findings and strategies for managing adverse events observed with emerging treatments for HR-MDS.

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Overview & Learning Objectives
Overview

Dr David Sallman, a leading expert in the treatment of higher-risk myelodysplastic neoplasms (HR-MDS), discusses the impact that emerging treatment options may have on clinical practice. He covers the latest updates to the classification of HR-MDS; outlines the mode of action of emerging agents; and discusses clinical evidence on their efficacy and safety, including the most recent data presented at the American Society of Hematology (ASH) Annual Meeting and Exposition 2022.

This activity is jointly provided by USF Health and touchIME. read more

Target Audience

This activity has been designed to meet the educational needs of oncologists and haematologists involved in the management of HR-MDS.

Disclosures

USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity. The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

Faculty

Dr David Sallman discloses: Advisory board or panel fees from AvenCell, bluebird bio, Bristol Myers Squibb, Intellia Therapeutics, Jasper Therapeutics, Kite Pharma, Novartis, Servier, Shattuck Labs and Syndax. Consultancy fees from AbbVie, Affimed, Gilead, Molecular Partners AG, Precigen Therapeutics Inc, Takeda and Zentalis Pharmaceuticals. Grants or research support from Aprea and Jazz Pharmaceuticals. Speaker’s bureau fees from Bristol Myers Squibb, Incyte and Servier.

Content reviewer

Alicia Canalejo, APRN has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Adriano Boasso has no financial interests/relationships or affiliations in relation to this activity.

USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

If you have questions regarding credit please contact cpdsupport@usf.edu 

Accreditations

Physicians

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

USF Health designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Advanced Practice Providers

Physician Assistants may claim a maximum of 0.75 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

Date of original release: 14 February 2023. Date credits expire: 14 February 2024.

If you have any questions regarding credit please contact cpdsupport@usf.edu

Learning Objectives

After watching this activity, participants should be better able to:

  • Recall the mechanisms of action for key emerging treatments for patients with HR-MDS
  • Describe the latest efficacy data for key emerging treatments for patients with HR-MDS
  • Discuss the safety profile of key emerging treatments for patients with HR-MDS
Faculty & Disclosures
Dr David Sallman

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA

David Sallman, MD, is an assistant member in the Department of Malignant Hematology at Moffitt Cancer Center, and assistant professor in the Department of Oncologic Sciences at the University of South Florida in Tampa, FL, USA. read more

Dr Sallman’s interests are myelodysplastic neoplasms (MDS) and acute myeloid leukaemia (AML). His research focuses on the development of targeted therapeutic strategies for patients with MDS and AML, based on the underlying mutational drivers of each disease. Specifically, he studies the genetic drivers of myeloid diseases to improve prognostication for patients and to allow for more personalized treatment.

He has been the lead principal investigator for phase I, II and III trials in patients with TP53 mutant MDS and AML. Dr Sallman also serves as lead principal investigator for multiple cellular therapy trials including chimeric antigen receptor cell therapy (CAR-T) and T-cell receptor therapy (TCR).

Dr Sallman has authored and co-authored numerous articles, books, book chapters and abstracts, and serves as a reviewer for multiple journals. He received a Young Investigator grant from the MDS Foundation in 2017 and was awarded a Career Development grant from the Vera and Joseph Dresner Foundation in 2018.

Dr David Sallman discloses: Advisory board or panel fees from AvenCell, bluebird bio, Bristol Myers Squibb, Intellia Therapeutics, Jasper Therapeutics, Kite Pharma, Novartis, Servier, Shattuck Labs and Syndax. Consultancy fees from AbbVie, Affimed, Gilead, Molecular Partners AG, Precigen Therapeutics Inc, Takeda and Zentalis Pharmaceuticals. Grants or research support from Aprea and Jazz Pharmaceuticals. Speaker’s bureau fees from Bristol Myers Squibb, Incyte and Servier.

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Question 1/5
Which of the following modes of action best describes that of magrolimab?

Bcl-2, B-cell lymphoma 2; CD47, cluster of differentiation 47; RARA, retinoic acid receptor alpha; TIM-3, T-cell immunoglobulin mucin-3.
Correct

Magrolimab is an immune checkpoint inhibitor targeting CD47. By inhibiting CD47-mediated immune escape, magrolimab facilitates phagocytosis of targeted cells. 

Abbreviation

CD47, cluster of differentiation 47.

Reference

Bewersdorf JP, et al. Ther Adv Hematol. 2020;11:2040620720955006.

Question 2/5
Considering the mode of action of emerging agents undergoing clinical trials, which therapy may be a relevant option for the treatment of patients with HR-MDS with mTP53, aged more than 70 years, with a bone marrow blast percentage >15% and not eligible for HMA therapy?

HMA, hypomethylating agent; HR-MDS, high-risk myelodysplastic neoplasm; mTP53, TP53 mutation.
Correct

TP53 mutations may be indicative of poor prognosis in HR-MDS.1 Eprenetapopt targets the mutated p53 to shift the equilibrium toward a functional conformation to selectively induce apoptosis in cells with TP53 mutation.2 In clinical trials, the combination of eprenetapopt + azacitidine has shown promising response rates (ORR of 71% in ITT population) and survival outcomes (median OS of 10.8 months in ITT population) in mTP53-positive patients with HR-MDS.2

Abbreviations

HR-MDS, high-risk myelodysplastic neoplasm; ITT, intention to treat; mTP53, TP53 mutation; ORR, overall response rate; OS, overall survival.

References

  1. Hellström-Lindberg E, et al. Haematologica. 2020;105:1765–79.
  2. Sallman D, et al. J Clin Oncol. 2021;39:1584–94.
Question 3/5
What do data from the phase II STIMULUS-MDS1 trial tell us about the potential benefit of adding sabatolimab to HMA in the treatment of patients with HR-MDS?

HMA, hypomethylating agent; HR-MDS, high-risk myelodysplastic neoplasm; OS, overall survival; PFS, progression-free survival.
Correct

STIMULUS-MDS1 was a phase II trial comparing sabatolimab + HMA (n=65) vs placebo + HMA (n=62) in patients with IR, HR, or vHR-MDS. There was no statistically significant difference in median PFS (11.1 months vs 8.5 months, p=0.102), or CR rate (21.5% vs 17.7%, p=0.769) in the sabatolimab + HMA vs placebo + HMA groups, respectively. In patients with bone marrow blast percentage <10%, there was also no statistically significant difference in PFS or CR between patients treated with sabatolimab + HMA compared with placebo + HMA.

Abbreviations

CR, complete response; HMA, hypomethylating agent; HR, high risk; IR, intermediate risk; MDS, myelodysplastic neoplasm; PFS, progression-free survival; vHR, very high risk.

Reference

Zeidan AM, et al. Blood. 2022;140(Suppl. 1):2063–5.

Question 4/5
Your patient is a 67-year-old male who has been diagnosed with HR-MDS by IPSS-M score. He is positive for mTP53 and treatment naive, but will be receiving magrolimab + azacitidine as part of a clinical trial. What would you advise him about expected treatment outcomes?

HR-MDS, high-risk myelodysplastic neoplasm; IPSS-M, Molecular International Prognostic Scoring System; mTP53, TP53 mutation; OS, overall survival; PFS, progression-free survival.
Correct

Data from a single-arm clinical trial showed promising response rates, with an ORR of 75%, and CR of 33%. The ORR was also comparable in the mTP53 positive and mTP53 negative subgroups. Median PFS was 11.6 months in the overall population, which was also similar when analysed by mTP53 status.1 The phase III placebo controlled ENHANCE trial is ongoing.2

Abbreviations

CR, complete response; mTP53, TP53 mutation; ORR, overall response rate; PFS, progression-free survival.

References

  1. Sallman DA, et al. Presented at: ASCO Annual Meeting, Chicago, IL, USA. 3–7 June 2022. Abstr 7017.
  2. Garcia-Manero G, et al. Presented at: ASCO Annual Meeting, Chicago, IL, USA. 4–8 June 2021. Abstr TPS7055.
Question 5/5
How would you counsel your patient who experienced ataxia and other neurological side effects after their first infusion of eprenetapopt as part of a clinical trial?
Correct

Neurological adverse events have been reported in clinical trials with eprenetapopt and azacitidine, including dizziness, peripheral sensory neuropathy and ataxia.1,2 However, these were associated with treatment infusion and resolved after the infusion phase. Furthermore, neurological adverse events were reversible after treatment with prochlorperazine and/or temporary treatment interruption.1

References

  1. Sallman DA, et al. J Clin Oncol. 2021;39:1584–94.
  2. Cluzeau T, et al. J Clin Oncol. 2021;39:1575–83.
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