Unmet Needs in CML | Later Line CML Treatment

CHALLENGES FOR RESISTANT AND INTOLERANT PATIENTS

PATIENT SCENARIOS AFTER 2 TKIs

CHALLENGES FOR RESISTANT AND INTOLERANT PATIENTS

Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach^1-6

More than half of patients with CML on their 3rd TKI were intolerant to prior TKIs⁷

intolerant to a previous TKI⁷

These data are specific to a Phase 2 study in which 60 patients with CML-CP or CML-AP were treated with 2 prior TKIs.⁷

Addressing intolerance after multiple TKIs remains an urgent need.^7,8

Cycling through ATP-competitive TKIs may lead to low response rates^2,9,10

In a Phase 1/2 study of 118 patients receiving bosutinib who had been previously treated with ≥2 TKIs¹¹:

24% of patients achieved CCyrR^11,*

15% of patients achieved MMR^11,*

PATIENT SCENARIOS AFTER 2 TKIs

Consider a different Ph+ CML-CP treatment for:

patient_suboptimal_response — Patient portrayal.

Patients who have moderate and persistent^† adverse reactions

These patients can face challenges that can lead to dosing changes or interruptions, as well as treatment discontinuation.¹¹

See Patients With Signs of Intolerance >

scemblix-ph-cml-patient-type-2 — Patient portrayal.

Patients with suboptimal responses on their 2nd TKI

These patients may have never responded, started losing the responses they initially achieved, or their responses have plateaued.^2,9,10

See Patients With Suboptimal Responses >

AP, accelerated phase; ATP, adenosine 5’-triphosphate; CCyR, complete cytogenetic response; MMR, major molecular response; NCCN, National Comprehensive Cancer Network.

*Data based on a multicenter, open-label Phase 1/2 study of best cumulative response rates to bosutinib (starting dose: 500 mg/day) in patients previously treated with and who developed resistance to a 1st-line TKI. Additionally, these patients were resistant to or intolerant to a ≥2nd-line TKI. One patient in the study had CML-AP. The median follow-up was 28.5 months. In this study, CCyR was defined as 0% Ph+ metaphases, and MMR was defined as ≥3-log reduction from standardized baseline in ratio of BCR::ABL to ABL transcripts.¹¹
^†Grade 2 toxicity that is unresponsive to optimal management, including dose adjustments.

References: 1. Soverini S, Gnani A, Colarossi S, et al. Blood. 2009;114(10):2168-2171. 2. Garg RJ, Kantarjian H, O’Brien S, et al. Blood. 2009;114(20):4361-4368. 3. Ibrahim AR, Paliompeis C, Bua M, et al. Blood. 2010;116(25):5497-5500. 4. Gambacorti-Passerini C, Brümmendorf TH, Kim D-W, et al. Am J Hematol. 2014;89(7):732-742. 5. Shah NP, Kim D-W, Kantarjian H, et al. Haematologica. 2010;95(2):232-240. 6. Kantarjian HM, Giles FJ, Bhalla KN, et al. Blood. 2011;117(4):1141-1145. 7. Giles FJ, Abruzzese E, Rosti G, et al. Leukemia. 2010;24(7):1299-1301. 8. Hochhaus A, Gambacorti-Passerini C, Abboud C, et al. Leukemia. 2020;34(8):2125-2137. 9. Bosi GR, Fogliatto LM, Costa TEV, et al. Hematol Transfus Cell Ther. 2019;41(3):222-228. 10. Iacob RE, Zhang J, Gray NS, Engen JR. PLoS One. 2011;6(1):e15929. 11. Khoury JH, Cortes JE, Kantarjian HM, et al. Blood. 2012;119(15):3403-3411. 12. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Chronic Myeloid Leukemia V.2.2024. ©National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed January 19, 2024. To view the most recent and complete version of the guidelines, go 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. 13. O’Brien SG, Guilhot F, Larson RA, et al. N Engl J Med. 2003;348(11):994-1004. 14. Saglio G, Kim D-W, Issaragrisil S, et al. N Engl J Med. 2010;362(24):2251-2259. 15. Kantarjian H, Shah NP, Hochhaus A, et al. N Engl J Med. 2010;362(24):2260-2270. 16. Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. J Clin Oncol. 2018;36(3):231-237. 17. Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Blood. 2011;118(17):4567-4576. 18. Shah NP, Kantarjian HM, Kim D-W, et al. J Clin Oncol. 2008;26(19):3204-3212. 19. Scemblix. Prescribing information. Novartis Pharmaceuticals Corp.

Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach^1-6

intolerant to a previous TKI⁷

Cycling through ATP-competitive TKIs may lead to low response rates^2,9,10

24% of patients achieved CCyrR^11,*

15% of patients achieved MMR^11,*

Consider a different Ph+ CML-CP treatment for:

Patient portrayal.

Patients who have moderate and persistent^† adverse reactions

Patient portrayal.

Patients with suboptimal responses on their 2nd TKI

IMPORTANT SAFETY INFORMATION

INDICATIONS

Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach1-6

intolerant to a previous TKI7

Cycling through ATP-competitive TKIs may lead to low response rates2,9,10

24% of patients achieved CCyrR11,*

15% of patients achieved MMR11,*

Consider a different Ph+ CML-CP treatment for:

Patient portrayal.

Patients who have moderate and persistent† adverse reactions

Patient portrayal.

Patients with suboptimal responses on their 2nd TKI

Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach^1-6

intolerant to a previous TKI⁷

Cycling through ATP-competitive TKIs may lead to low response rates^2,9,10

24% of patients achieved CCyrR^11,*

15% of patients achieved MMR^11,*

Patients who have moderate and persistent^† adverse reactions