Press Release: Novartis Scemblix(R) receives -2-

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References:

1. Hochhaus A, Wang J, Kim DW, et al. Asciminib in newly diagnosed chronic

myeloid leukemia. N Engl J Med. 2024;391(10):885-898.

doi:10.1056/NEJMoa2404069

2. Cortes JE, Hochhaus A, Hughes TP, et al. Asciminib Continues to Provide

Superior Efficacy and Favorable Safety and Tolerability vs Tyrosine

Kinase Inhibitors In Newly Diagnosed Chronic Myeloid Leukemia in

ASC4FIRST: Week 96 Update. Presented at: 66th ASH Annual Meeting &

Exposition; December 7 -- 10, 2024; San Diego, CA.

3. Kota VK, Wei D, Yang D, et al. Treatment Patterns and Modifications of

Tyrosine Kinase Inhibitors (TKI) Therapy in Early Lines in Patients with

Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Real-World Analysis

from a Large Commercial Claims Database in the United States (US). Blood.

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4. Hochhaus, A., & Ernst, T. 2021. TKI discontinuation in CML: How do we

make more patients eligible? How do we increase the chances of a

successful treatment-free remission? Hematology Am Soc Hematol Educ

Program. 2021;1:106--112.

5. Scemblix (asciminib) Prescribing information. East Hanover, New Jersey,

USA: Novartis Pharmaceuticals Corporation; October 2024.

6. Novartis data on file.

7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines

in Oncology (NCCN Guidelines(R)) Chronic Myeloid Leukemia Version 1.2026.

Accessed September 11, 2025.

https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf

8. Apperley JF, Milojkovic D, Cross NCP, et al. 2025 European LeukemiaNet

recommendations for the management of chronic myeloid leukemia. Leukemia.

2025;39:1797--1813. doi:10.1038/s41375-025-02664-w.

9. Scemblix. EMA Summary of Product Characteristics. Novartis Europharm

Limited; 2022.

10. A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly

Diagnosed Ph+ CML-CP (ASC4FIRST). ClinicalTrials.gov identifier:

NCT04971226. Updated March 25, 2024. Accessed September 11, 2025.

https://clinicaltrials.gov/study/NCT04971226

11. Rea D, Mauro MJ, Boquimpani C, et al. A Phase 3, Open-Label, Randomized

Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After 2 or

more prior TKIs. Blood. 2021;138(21):2031-2041.

doi:10.1182/blood.2020009984

12. Cortes JE, Hughes TP, Mauro MJ, et al. Asciminib, a First-in-Class STAMP

Inhibitor, Provides Durable Molecular Response in Patients (pts) with

Chronic Myeloid Leukemia (CML) Harboring the T315I Mutation: Primary

Efficacy and Safety Results from a Phase 1 Trial. Oral presentation at:

ASH Annual Meeting; Dec. 7, 2020.

13. Schoepfer J, Jahnke W, Berellini G, et al. Discovery of Asciminib

(ABL001), an Allosteric Inhibitor of the Tyrosine Kinase Activity of

BCR-ABL1. J Med Chem. 2018;61(18):8120-8135.

doi:10.1021/acs.jmedchem.8b01040

14. Wylie AA, Schoepfer J, Jahnke W, et al. The allosteric inhibitor ABL001

enables dual targeting of BCR--ABL1. Nature. 2017;543(7647):733-737.

doi:10.1038/nature21702

15. Hughes TP, Mauro MJ, Cortes JE, et al. Asciminib in Chronic Myeloid

Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019;

381(24):2315-2326. doi:10.1056/NEJMoa1902328

16. Hughes TP, et al. Expanded Phase 1 Study of ABL001, a Potent, Allosteric

Inhibitor of BCR-ABL, Reveals Significant and Durable Responses in

Patients with CML-Chronic Phase with Failure of Prior TKI Therapy.

Presented at: ASH Annual Meeting & Exposition; Dec. 5, 2016.

17. Ottmann OG, Alimena G, DeAngelo DJ, et al. ABL001, a Potent, Allosteric

Inhibitor of BCR-ABL, Exhibits Safety and Promising Single- Agent

Activity in a Phase I Study of Patients with CML with Failure of Prior

TKI Therapy. Blood. 2015;126(23):138. doi:10.1182/blood.V126.23.138.138

18. Mauro MJ, Kim DW, Cortes J, et al. Combination of Asciminib Plus

Nilotinib (NIL) or Dasatinib (DAS) in Patients (PTS) with Chronic Myeloid

Leukemia (CML): Results from a Phase 1 Study. Presented at: EHA Annual

Meeting; June 15, 2019.

19. Cortes JE, Lang F, Kim DW, et al. Combination Therapy Using Asciminib

Plus Imatinib (IMA) in Patients (PTS) with Chronic Myeloid Leukemia

(CML): Results from a Phase 1 Study. Presented at: EHA Annual Meeting;

June 15, 2019.

20. Manley PW, Barys L, Cowan-Jacob SW. The specificity of asciminib, a

potential treatment for chronic myeloid leukemia, as a myristate-pocket

binding ABL inhibitor and analysis of its interactions with mutant forms

of BCR-ABL1 kinase. Leuk Res. 2020;98:106458.

doi:10.1016/j.leukres.2020.106458

21. Study of Efficacy of CML-CP Patients Treated with ABL001 Versus Bosutinib,

Previously Treated With 2 or More TKIs. ClinicalTrials.gov identifier:

NCT03106779. Updated February 7, 2024. Accessed September 11, 2025.

https://clinicaltrials.gov/ct2/show/NCT03106779

22. Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase

(CML-CP) With and WithoutT315I Mutation (AIM4CML). ClinicalTrials.gov

identifier: NCT04666259. Updated September 7, 2023. Accessed September

11, 2025. https://clinicaltrials.gov/ct2/show/NCT04666259

23. Study of Efficacy And Safety Of Asciminib In Combination With Imatinib In

Patients With Chronic Myeloid Leukemia In Chronic Phase (CML-CP).

ClinicalTrials.gov identifier: NCT03578367. Updated March 22, 2024.

Accessed September 11, 2025.

https://clinicaltrials.gov/ct2/show/NCT03578367

24. Study of Efficacy and Safety of CML-CP Patients Treated With Asciminib

Versus Best Available Therapy, Previously Treated With 2 or More Tyrosine

Kinase Inhibitors. ClinicalTrials.gov identifier: NCT04795427. Updated

October 19, 2023. Accessed September 11, 2025.

https://clinicaltrials.gov/ct2/show/NCT04795427

25. A Phase I Study of Oral ABL001 in Patients With CML or Ph+ ALL.

ClinicalTrials.gov identifier: NCT02081378. Updated March 18, 2024.

Accessed September 11, 2025.

https://clinicaltrials.gov/ct2/show/NCT02081378

26. Asciminib Treatment Optimization in >= 3rd Line CML-CP.

ClinicalTrials.gov identifier: NCT04948333. Updated February 28, 2024.

Accessed September 11, 2025.

https://clinicaltrials.gov/ct2/show/NCT04948333

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(END) Dow Jones Newswires

October 17, 2025 06:37 ET (10:37 GMT)