Lisa’s Story: Managing Side Effects Along the Road to Meeting CML Treatment Goals

After navigating treatment-associated side effects on her own, Lisa eventually felt comfortable telling her doctor how hard it was living with treatment side effects. This took some courage. Understandably, some people with Ph+ CML-CP are reluctant to speak up because switching treatments can come with complicated feelings. Like Lisa mentioned, patients may be fearful of trying something different as it may mean getting used to new side effects.

After a few conversations, Lisa and her doctor agreed it was time for a change, and together they decided on Scemblix. Her doctor helped ease her concerns by telling her why he felt Scemblix may be a better fit.

Scemblix is approved by the FDA for adults living with Ph+ CML-CP who have previously been treated with two or more TKI medications.² It targets CML differently than other TKIs by blocking tyrosine kinases from a different site, which may help patients overcome the resistance they may experience with other TKIs.^3-14

In a clinical trial of patients who had tried two or more TKIs, nearly twice as many patients achieved a major molecular response (MMR) with Scemblix (25%, 40 of 157) at 24 weeks than with Bosulif® (bosutinib) (13%, 10 of 76). At 96 weeks, almost 2 years after the start of the trial, 59 out of 157 patients (38%) on Scemblix achieved MMR compared with 12 out of 76 patients (16%) on Bosulif.²

Additionally, three times fewer patients (7% vs. 25%) treated with Scemblix in a clinical trial needed to stop treatment permanently due to side effects compared with those taking Bosulif. This trend continued almost two years from the start of the trial at 96 weeks. Of patients taking Bosulif, 26% (20 of 76 patients) had to stop taking their medication due to side effects compared to 8% of those taking Scemblix (12 of 156 patients). In this clinical trial, the most common side effects reported (20%) with SCEMBLIX were nose/throat infections; pain in the muscles, bones, or joints; headache; and tiredness.²

If you or someone you know is living with Ph+ CML-CP and can relate to Lisa’s story and are struggling with side effects, it may be time to have a conversation with your doctor . Visit http://www.scemblix-videoseries.com/ to watch more of Lisa’s story, hear from others, and learn more about Scemblix.

Important Safety Information and Approved Uses

APPROVED USES for SCEMBLIX® (asciminib) Tablets

SCEMBLIX is a prescription medicine used to treat adults with:

• Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)

• The effectiveness of SCEMBLIX in patients previously treated with 2 or more TKIs is based on a study that measured major molecular response (MMR) rates. No clinical information is available to show if these patients treated with SCEMBLIX live longer or if their symptoms improve. Ongoing studies exist to find out how SCEMBLIX works over a longer period of time.

• Ph+ CML in CP with the T315I mutation

It is not known if SCEMBLIX is safe and effective in children.

IMPORTANT SAFETY INFORMATION for SCEMBLIX

Before taking SCEMBLIX, tell your doctor about all your medical conditions, including if you:

• have a history of inflammation of your pancreas (pancreatitis)

• have a history of heart problems or blood clots in your arteries and veins (types of blood vessels)

• are pregnant or plan to become pregnant. SCEMBLIX can harm your unborn baby

◦ Your doctor will do a pregnancy test before you start treatment with SCEMBLIX

◦ Females who are able to become pregnant should use effective birth control during treatment and for 1 week after your last dose of SCEMBLIX. Talk to your doctor about birth control methods that may be right for you

◦ Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with SCEMBLIX

• are breastfeeding or plan to breastfeed. It is not known if SCEMBLIX passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of SCEMBLIX

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SCEMBLIX and other medicines may affect each other and cause side effects.

SCEMBLIX may cause serious side effects, including:

• Low blood cell counts: SCEMBLIX may cause low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Your doctor will do blood tests to check your blood cell counts every 2 weeks for the first 3 months of treatment and then monthly or as needed during treatment with SCEMBLIX. Tell your doctor right away if you have unexpected bleeding or easy bruising, blood in your urine or stools, fever, or any signs of an infection

• Pancreas problems: SCEMBLIX may increase enzymes in your blood called amylase and lipase, which may be a sign of pancreatitis. Your doctor may do blood tests monthly or as needed during treatment with SCEMBLIX to check for problems with your pancreas. Tell your doctor right away if you have sudden stomach-area pain or discomfort, nausea, or vomiting

• High blood pressure: Your doctor may check your blood pressure and treat any high blood pressure during treatment with SCEMBLIX as needed. Tell your doctor if you develop elevated blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath

• Allergic reaction: Stop taking SCEMBLIX and get medical help right away if you get any signs or symptoms of an allergic reaction, including

∘ trouble breathing or swallowing

∘ swelling of the face, lips, or tongue

∘ skin rash or flushing of your skin

∘ feeling dizzy or faint

∘ fever

∘ fast heartbeat

• Heart and blood vessel (cardiovascular) problems: SCEMBLIX may cause heart and blood vessel problems, including heart attack, stroke, blood clots, blockage of your arteries, heart failure, and abnormal heartbeat, which can be serious and may sometimes lead to death. These heart and blood vessel problems can happen in people with risk factors or a history of these problems, and/or previously treated with other TKI medicines. Your doctor may monitor you for heart and blood vessel problems and treat you as needed during treatment with SCEMBLIX. Tell your doctor or get medical help right away if you get:

∘ shortness of breath

∘ chest pain or pressure

∘ a feeling like your heart is beating too fast or you feel abnormal heartbeats

∘ swelling in your ankles or feet

∘ dizziness

∘ weight gain

∘ numbness or weakness on one side of your body

∘ decreased vision or loss of vision

∘ trouble talking

∘ pain in your arms, legs, back, neck, or jaw

∘ headache

∘ severe stomach-area pain

The most common side effects of SCEMBLIX include:

• nose, throat, or sinus (upper respiratory tract) infections

• muscle, bone, or joint pain

• tiredness

• nausea

• rash

• diarrhea

• decreased blood platelet counts, white blood cell counts, and red blood cell counts

• increased blood fat (triglycerides) levels

• increased blood creatine kinase levels

• increased blood liver enzyme levels

• increased blood pancreas enzyme (amylase and lipase) levels

• increased blood uric acid levels

Your doctor may change your dose, temporarily stop, or permanently stop treatment with SCEMBLIX if you have certain side effects.

SCEMBLIX may cause fertility problems in females. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

These are not all the possible side effects of SCEMBLIX. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information, including Patient Information.

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References:

1. American Cancer Society. What Is Chronic Myeloid Leukemia? 2021. Available at https://www.cancer.org/cancer/chronic-myeloid-leukemia/ about/what-is-cml.html.

2. Scemblix. Prescribing Information. Novartis Pharmaceuticals Corp.

3. Rea D, Mauro MJ, Boquimpani C, et al. A Phase 3, OpenLabel, Randomized Study of Asciminib, a STAMP Inhibitor, vs Bosutinib in CML After≥ 2 Prior TKIs. Blood. 2021;138(21):2031-2041. doi:10.1182/blood.2020009984

4. 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.

5. Cortes JE, Réa D, Mauro MJ, et al. Oral presentation at ASCO 2022 ; June 3-7, 2022. Chicago IL and virtual. Abstract 7004.

6. Réa D, Hochhaus A, Mauro MJ, et al. Oral presentation at EHA 2022; June 9-17, 2022. Vienna Austria and virtual. Abstract S155.

7. 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. Leukemia Research. 2020 Nov;98:106458. doi: 10.1016/j.leukres.2020.106458.

8. Wylie AA, Schoepfer J, Jahnke W, et al. The allosteric inhibitor ABL001 enables dual targeting of BCR–ABL1. Nature. 2017;543(7647):733-737.

9. Schoepfer J, Jahnke W, Berellini G, et al. Discovery of asciminib (ABL001), an allosteric inhibitor of the tyrosine kinase activity of BCR-ABL1. Journal of Medicinal Chemistry. 2018;61(18):8120-8135.

10. Hughes TP, Mauro MJ, Cortes JE, et al. Asciminib in chronic myeloid leukemia after ABL kinase inhibitor failure. New England Journal of Medicine. 2019; 381(24):2315-2326.

11. Hughes TP, Goh Y, Ottmann OG, 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. Poster presented at: ASH Annual Meeting & Exposition; Dec. 5, 2016.

12. 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.

13. Mauro MJ, DeAngelo D, Kim D, 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. Poster presented at: EHA Annual Meeting; June 15, 2019.

14. Cortes JE, Lang F, Kim D, et al. Combination therapy using asciminib plus imatinib (IMA) in patients (PTS) with chronic myeloid leukemia (CML): Results from a phase 1 study. Poster presented at: EHA Annual Meeting; June 15, 2019.

 

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