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Challenges
in NPM1-m AML

Challenges
in NPM1-m AML

NPM1-m is the most common menin-dependent AML—~30% of all adult AML cases1,2

image of an inverted pyramid showing NPM1-m is the most common menin-dependent AML

NPM1-m AML remains challenging, with considerable variability in patient outcomes across the treatment continuum.10-13

Despite recent therapeutic advances, many patients with NPM1-m AML continue to relapse with poor outcomes12,14

In patients with NPM1-m AML,

50%

will relapse—most within 1 year12,14

Duration of first remission in patients with relapsing NPM1-m AML12,a

aBased on a retrospective analysis of patients with R/R NPM1-m AML (n=206).12

Similar to those in the relapse setting without NPM1m,

Patients with relapsing NPM1-m AML face low survival rates12

Survival associated with NPM1 mutational status at AML relapse12,b

Median OS

NPM1m

(n=206)

6.1

months

NPM1-wt

(n=1516)

5.5

months

Median RFS

NPM1m

(n=102)

5.5

months

NPM1-wt

(n=496)

5.6

months

Twelve-month survival was as low as 23% in the subset of patients aged ≥60 years with R/R NPM1-m AML.13

bBased on a retrospective analysis of patients with R/R AML with NPM1m (n=206) compared with NPM1-wt (n=1516)
  treated with standard-of-care therapies.12

bBased on a retrospective analysis of patients
  with R/R AML with NPM1m (n=206) compared
  with NPM1-wt (n=1516) treated with standard-
  of-care therapies.12

With no currently approved treatments, there is an urgent need for novel therapies designed to target the underlying disease mechanism driving NPM1-m AML4,5

Current research exploring the potential of menin inhibition for menin-dependent AMLs, such as NPM1-m, may offer new hope for patients and the AML community.4,5

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Knowing a patient’s NPM1-m status is essential for guiding treatment decisions and care1,15,16

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend expedited testing for NPM1m at diagnosis and for repeat testing at relapse or progression to guide treatment.15

Accurate NPM1-m diagnosis

Detection of NPM1m drives to a critical diagnosis of AML, even at ≥10% myeloid blasts or equivalents,c regardless of prior history of MDS.1,16

Guiding clinical decisions

Comprehensive mutational profiling, including NPM1m, is critical for prognosis, risk stratification, and guiding treatment decisions.15,16

Ahead of the evolving treatment landscape

As new research emerges, routine testing for NPM1m may enable tailored decision-making in the future.15,16

AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; NCCN, National Comprehensive Cancer Network® (NCCN®); NPM1-m, mutated nucleophosmin 1; NPM1m, nucleophosmin 1 mutation; NPM1-wt, wild-type nucleophosmin 1; OS, overall survival; RFS, relapse-free survival; R/R, relapsed/refractory.

cMyeloblasts, monoblasts, and megakaryoblasts detected in the bone marrow or blood.
References

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References

1. Falini B, Dillon R. Criteria for diagnosis and molecular monitoring of NPM1-mutated AML. Blood Cancer Discov. 2024;5(1):8-20. doi:10.1158/2643-3230.BCD-23-0144 2. Sharma N, Liesveld JL. NPM 1 mutations in AML—the landscape in 2023. Cancers (Basel). 2023;15(4):1177. doi:10.3390 /cancers15041177 3. American Cancer Society. Key statistics for acute myeloid leukemia (AML). Updated June 5, 2024. Accessed October 22, 2024. https://www.cancer.org/cancer/ types/acute-myeloid-leukemia/about/ key-statistics.html 4. Issa GC, Ravandi F, DiNardo CD, Jabbour E, Kantarjian HM, Andreeff M. Therapeutic implications of menin inhibition in acute leukemias. Leukemia. 2021;35(9):2482-2495. doi:10.1038/s41375-021-01309-y 5. Candoni A, Coppola G. A 2024 update on menin inhibitors. A new class of target agents against KMT2A-rearranged and NPM1-mutated acute myeloid leukemia. Hematol Rep. 2024;16(2):244-254. doi:10.3390/hematolrep16020024 6. Bertrums EJM, Smith JL, Harmon L, et al. Comprehensive molecular and clinical characterization of NUP98 fusions in pediatric acute myeloid leukemia. Haematologica. 2023;108(8):2044-2058. doi:10.3324/haematol.2022.281653 7. National Cancer Institute. Acute myeloid leukemia with inv(3) (q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2, MECOM. Accessed October 22, 2024. https://seer.cancer.gov/seertools/ hemelymph/51f6cf59e3e27c3994bd547d/ 8. National Cancer Institute. Acute myeloid leukemia with mutated RUNX1. Accessed October 22, 2024. https://seer.cancer.gov/seertools/ hemelymph/5a7e288d1ef557f9c8636d31/ 9. Burrows F, Wu T, Kessler L, et al. A novel small molecule menin-MLL inhibitor for potential treatment of MLL-rearranged leukemias and NPM1/DNMT3A-mutant AML. Poster presented at: AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Discovery, Biology, and Clinical Applications; October 26-30, 2017; Philadelphia, PA. 10. Falini B, Brunetti L, Sportoletti P, Martelli MP. NPM1-mutated acute myeloid leukemia: from bench to bedside. Blood. 2020;136(15):1707-1721. doi:10.1182/blood.2019004226 11. Lachowiez CA, Loghavi S, Kadia TM, et al. Outcomes of older patients with NPM1-mutated AML: current treatments and the promise of venetoclax-based regimens. Blood Adv. 2020;4(7):1311-1320.doi:10.1182/ bloodadvances.2019001267 12. Issa GC, Bidikian A, Venugopal S, et al. Clinical outcomes associated with NPM1 mutations in patients with relapsed or refractory AML. Blood Adv. 2023;7(6):933-942. doi:10.1182/bloodadvances.2022008316 13. Issa GC, Bidikian A, Venugopal S, et al. Clinical outcomes associated with NPM1 mutations in patients with relapsed or refractory AML [Supplemental tables and figures]. Accessed October 22, 2024. https://ashpublications.org/ bloodadvances/article/7/6/933/486963/ Clinical-outcomes-associated-with-NPM1-mutations 14. Wang R, Xu P, Chang L-L, Zhang S-Z, Zhu H-H. Targeted therapy in NPM1-mutated AML: knowns and unknowns. Front Oncol. 2022;12:972606. doi:10.3389/fonc.2022.972606 15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed October 22, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. 16. Döhner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345-1377. doi:10.1182/blood.2022016867

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