
The Power of Patient-Provider Dialogue to Help Shape First-Line Treatment for Ph+ CML in Chronic Phase
This is a featured episode with expert discussions on the care of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, or Ph+ CML-CP, intended to inform US healthcare professionals.
Hosted by Amanda Meyer, joined by Dr. Stephen Strickland, MD, MSCI, Director, Leukemia Research, Sarah Cannon Research Institute (SCRI).
SPEAKER: Stephen Strickland, MD, MSCI, Director, Leukemia Research, Sarah Cannon Research Institute (SCRI)
This episode is sponsored by Novartis Pharmaceuticals Corporation, and payment for Dr. Strickland's participation has been made to his institution.
Throughout this podcast episode, Dr. Strickland will dive into why first-line treatment decisions matter in CML in chronic phase—and how strong communication between providers and patients can play a vital role in the treatment journey for patients.
OncLive® Podcast: The Power of Patient-Provider Dialogue to Help Shape First-Line Treatment for Ph+ CML in Chronic Phase
Amanda Meyer, Host: Welcome. This podcast from OncLive provides oncology professionals with some resources and information they need to help provide the best patient care. I’m your host, Amanda Meyer, and today we’re diving into a critical conversation for anyone involved in the care of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, or Ph+ CML-CP. This episode explores why first-line treatment decisions matter in CML in chronic phase—and how strong communication between providers and patients can play a vital role in the treatment journey for patients. Joining me today is Dr Stephen Strickland, board-certified, fellowship-trained medical oncologist and hematologist and Director of Leukemia Research at Sarah Cannon Research Institute to discuss the treatment landscape of Ph+ CML-CP. This episode is sponsored by Novartis Pharmaceuticals Corporation, and payment for Dr Strickland's participation has been made to his institution. Dr Strickland, thanks for being here.
Stephen Strickland, MD: Thanks so much for having me. It’s a pleasure to join you today.
Amanda Meyer, Host: We’re glad to have you. Let’s get right to it. Why is the first-line treatment decision so important for adults with CML in chronic phase?
Stephen Strickland, MD: With Ph+ CML-CP, the choice of first-line therapy can be an important step on their treatment journey.2 There’s a growing body of evidence suggesting that achieving major molecular response, or MMR, is a critical treatment milestone.2 And it’s important to recognize that CML is a chronic disease, it’s a lifelong disease for most patients.3 And when we’re thinking about treatment—especially first-line treatment—the goal is not just response, but molecular response that is deep. So, the first-line decisions matter. We want to get patients on an appropriate therapy that will help them achieve their molecular responses. Starting with a treatment option that offers them the opportunity to achieve MMR and deep molecular response, and that may give patients a chance to reach their key milestones.4 We only get one shot at first-line—so rather than save a treatment in the back pocket, so to speak, I try to work with the patient to choose a good fit for them from the start.
Amanda Meyer, Host: That’s such a powerful way to think about it—and a good reminder when thinking about treatment plans. Let’s talk about patient-provider communication. How do these conversations shape first-line treatment decisions for CML in chronic phase?
Stephen Strickland, MD: For me, they play a huge role. Treatment decisions aren’t one-size-fits-all. Each patient presents with their own concerns, their own life rhythms and how treatment will fit into those. And, of course, we may need to account for different comorbidities, too. Some patients may have cardiovascular risk factors, others might have diabetes that they are managing or gastrointestinal issues. So, all of that has to factor into our treatment choices.
Amanda Meyer, Host: And the safety and tolerability profile plays a big role as well, right?
Stephen Strickland, MD: Absolutely. I think tolerability isn’t just about what a patient can handle at the moment—but it’s about what they can realistically live with for years. At diagnosis, patients are often willing to take on a lot. Their world has just been changed overnight. They’re motivated; they want to treat this. But what might feel manageable in month 1 might not feel the same in month 9. It’s a little like a leaky faucet. At first, the side effects may have felt like manageable "drips," but they can become increasingly burdensome over time. Even low-grade side effects that seemed like they could be manageable, if they persist, can lead to frustration. And that frustration can lead to missed doses or even stopping treatment altogether. That’s why shared decision-making is so important. When patients feel heard and informed about treatment decisions and when their treatment plan reflects their needs and their lifestyle, they may be more likely to stay on therapy.5 It’s easier to stick with the plan—because it’s our plan, not just mine. That kind of trust and alignment can go a long way.
Amanda Meyer, Host: Let’s turn to the treatment landscape. SCEMBLIX, or asciminib, 40 milligram tablets, is approved to treat adults with newly diagnosed or previously treated Ph+ CML-CP.1 ASC4FIRST is the clinical trial that led to its FDA approval in the first-line. What should clinicians know?
Stephen Strickland, MD: Yes, as you mentioned, asciminib is approved to treat adults with newly diagnosed or previously treated Ph+ CML-CP.1 The newly diagnosed indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials. Warnings and precautions for asciminib include myelosuppression, pancreatic toxicity, hypertension, hypersensitivity, cardiovascular toxicity, and embryo-fetal toxicity. The most common adverse reactions, occurring in at least 20% of patients, are musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, and diarrhea.1 Please listen until the end for additional Important Safety Information.
ASC4FIRST had a ground-breaking study design evaluating the efficacy, safety, and tolerability profile of asciminib versus investigator-selected tyrosine kinase inhibitors, or TKIs—imatinib, nilotinib, dasatinib, and bosutinib—in newly diagnosed adult patients with Ph+ CML-CP.1,6 In fact, asciminib is the only medication that has been tested against these commonly used first- and second-generation TKIs.1 ASC4FIRST was a multicenter, randomized, active-controlled, open-label study of 405 adults with newly diagnosed Ph+ CML-CP. Investigators, in consultation with patients, preselected the appropriate TKI and evaluated patients' EUTOS long-term survival, or ELTS, risk scores. Patients were then stratified by preselected TKI and ELTS score. Once stratified, they were randomized one to one to receive either asciminib or an Investigator-selected TKI. 201 patients received asciminib at 80 milligrams once daily, and 204 patients received IS-TKIs until unacceptable toxicity or treatment failure occurred. 1,6
In the two primary end points of the ASC4FIRST trial, asciminib showed superior MMR rates at week 48 compared with all Investigator-selected TKIs. The MMR rate in the asciminib arm was 68 percent with a 95 percent confidence interval of 61 to 74 percent, compared to 49 percent with a 95 percent confidence interval of 42 to 56 percent in the Investigator-selected TKIs arm.1 This was a difference of 19 percent with a 95 percent confidence interval of 10 to 28 and a P value of less than 0.001. Asciminib also showed superior MMR rates at week 48 in the imatinib stratum, which included 101 patients in the asciminib arm and 102 patients in the imatinib arm. The MMR rate in the asciminib arm was 69 percent with a 95 percent confidence interval of 59 to 78 percent, compared to 40 percent with a 95 percent confidence interval of 31 to 50 percent in the imatinib arm. This was a difference of 30 percent with a 95 percent confidence interval of 17 to 42 and a P value of less than 0.001.1 At 48 weeks, the most common adverse reaction, which occurred in 20 percent or more of patients who received asciminib, was musculoskeletal pain.7
In the two key secondary end points at 96 weeks, the MMR rate was 74 percent with a 95 percent confidence interval of 68 to 80 percent in the asciminib arm, and 52 percent with a 95 percent confidence interval of 45 to 59 percent in the investigator-selected TKI arm.1 In the imatinib stratum at 96 weeks, the MMR rate was 76 percent with a 95 percent confidence interval of 67 to 84 percent in the asciminib arm, and 47 percent with a 95 percent confidence interval of 37 to 57 percent, in the imatinib arm.1 At 96 weeks, the most common adverse reactions—again, defined as those experienced by 20 percent or more patients who received asciminib—were musculoskeletal pain and rash.1 The number of patients evaluated in each arm in the full data set and imatinib stratum were the same between the 48- and 96-week analyses. To learn more about asciminib, including additional Important Safety Information, listen until the end and visit
Finally, its unique mechanism of action is also worth highlighting. Asciminib is the first and only approved inhibitor that binds to the ABL myristoyl pocket, offering a different approach to treatment.1
Amanda Meyer, Host: What has the real-world feedback been like from your patients?
Stephen Strickland, MD: It’s been encouraging. Of course, each patient experience is unique.
Amanda Meyer, Host: And what has your experience been like when it comes to prescribing asciminib?
Stephen Strickland, MD: In my practice, it’s been a smooth process. Prescribing asciminib and starting appropriate patients on therapy has been straightforward. Our practice has found that aligning requests with the ASC4FIRST data and FDA approval has been effective in starting appropriate candidates for asciminib on therapy without delays or administrative hurdles. Patient access programs can also be instrumental. These programs may help patients—including those who are uninsured or underinsured—access the therapy we believe is most appropriate for them.
Amanda Meyer, Host: And what can you tell us about how you approach shared decision making with patients?
Stephen Strickland, MD: Delivering a diagnosis like CML isn’t just a clinical moment—it’s a human one. As physicians, we’re armed with knowledge, and our instinct is often to dive into the data, the treatment plan, and the path forward. That’s our comfort zone. But when you’re telling a patient they have CML, you have to pause, you have to give them space to process. In some cases, it means having them come back for a second conversation once they’ve had time to absorb the news. I think that pause can be powerful. It creates space for reflection and shared decision-making, as well as an opportunity to align on what matters most to the patient. No two patients are alike and, when choosing a first-line treatment, I strongly believe our patients’ preferences, concerns, and goals should guide the conversation as much as our own expertise in the field.
Amanda Meyer, Host: Final question for you. If there’s one takeaway you’d want hematologists to remember from today’s conversation, what would it be?
Stephen Strickland, MD: The choice of first-line therapy can be an important step on the treatment journey.2 There is no one-size-fits-all approach. But with the right tools and open dialogue, I think we can better support each patient on their individual path.
Amanda Meyer, Host: Thank you, Dr Strickland, for joining us and sharing these valuable insights. That’s all for this episode. Please stay tuned for Indications and Important Safety Information for asciminib.
INDICATIONS
SCEMBLIX® (asciminib) tablets is indicated for the treatment of adult patients with:
- Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP)
- This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s)
- Previously treated Ph+ CML in CP
IMPORTANT SAFETY INFORMATION for SCEMBLIX
Myelosuppression
- Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
- Perform complete blood counts every 2 weeks for the first 3 months of treatment and monthly thereafter or as clinically indicated. Monitor patients for signs and symptoms of myelosuppression
- Based on the severity of thrombocytopenia and/or neutropenia, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information
Pancreatic Toxicity
- Pancreatitis (including grade 3 reactions) and elevation in serum lipase and amylase (including grade 3/4 elevations), have occurred in patients receiving SCEMBLIX
- Assess serum lipase and amylase levels monthly during treatment with SCEMBLIX, or as clinically indicated. Monitor patients for signs and symptoms of pancreatic toxicity. Perform more frequent monitoring in patients with a history of pancreatitis
- If lipase and amylase elevation are accompanied by abdominal symptoms, temporarily withhold SCEMBLIX and consider appropriate diagnostic tests to exclude pancreatitis
- Based on the severity of lipase and amylase elevation, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information
Hypertension
- Hypertension, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
- Monitor and manage hypertension using standard antihypertensive therapy during treatment with SCEMBLIX as clinically indicated
- For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypertension
Hypersensitivity
- Hypersensitivity, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX. Reactions included rash, edema, and bronchospasm
- Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated
- For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypersensitivity
Cardiovascular Toxicity
- Cardiovascular toxicity (including ischemic cardiac and central nervous system conditions; and arterial thrombotic and embolic conditions) and cardiac failure have occurred in patients receiving SCEMBLIX. Some toxicities were grade 3/4 and 5 fatalities were reported
- Arrhythmia, including QTc prolongation, have occurred in patients receiving SCEMBLIX. Some of these arrhythmias were grade 3/4
- Monitor patients with a history of cardiovascular risk factors for cardiovascular signs and symptoms. Initiate appropriate treatment as clinically indicated
- For grade 3 or higher cardiovascular toxicity, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of cardiovascular toxicity
Embryo-Fetal Toxicity
- SCEMBLIX can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus if SCEMBLIX is used during pregnancy or if the patient becomes pregnant while taking SCEMBLIX
- Verify the pregnancy status of females of reproductive potential prior to starting treatment with SCEMBLIX. Advise females to use effective contraception during treatment and for at least 1 week after the last SCEMBLIX dose
ADVERSE REACTIONS
- Most common adverse reactions (≥20%) were musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, arthralgia, and diarrhea
- Most common select laboratory abnormalities (≥20%) were lymphocyte count decreased, leukocyte count decreased, platelet count decreased, neutrophil count decreased, calcium corrected decreased, lipase increased, cholesterol increased, uric acid increased, alanine aminotransferase increased, alkaline phosphatase increased, hemoglobin decreased, triglycerides increased, creatine kinase increased, amylase increased, and aspartate aminotransferase increased
DRUG INTERACTIONS
- Asciminib is an inhibitor of CYP3A4, CYP2C9, P-gp, and BCRP. Asciminib is a CYP3A4 substrate
- Closely monitor for adverse reactions during concomitant use of strong CYP3A4 inhibitors and SCEMBLIX at 200 mg twice daily
- Avoid concomitant use of itraconazole oral solution containing hydroxypropyl-β-cyclodextrin and SCEMBLIX at all recommended doses
- Closely monitor for adverse reactions during concomitant use of certain CYP3A4 substrates and SCEMBLIX at 80 mg total daily dose. Avoid use of SCEMBLIX at 200 mg twice daily
- Avoid concomitant use of CYP2C9 substrates and SCEMBLIX at all recommended doses. If coadministration with 80 mg total daily dose is unavoidable, reduce the CYP2C9 substrate dosage as recommended in its prescribing information. If coadministration with 200 mg twice daily is unavoidable, consider alternative therapy with a non-CYP2C9 substrate
- Closely monitor for adverse reactions during concomitant use of certain P-gp substrates and SCEMBLIX at all recommended doses
- Avoid concomitant use of rosuvastatin and SCEMBLIX at all recommended doses. Closely monitor for adverse reactions during concomitant use of other BCRP substrates and SCEMBLIX at all recommended doses
Please see full
Amanda Meyer, Host:
Important Safety Information for SCEMBLIX and a link to the full Prescribing Information is available beneath the audio player for this episode.
Thank you for joining us for this episode from OncLive, courtesy of Novartis Pharmaceuticals Corporation.
REFERENCES
- Scemblix. Prescribing information. Novartis Pharmaceuticals Corp.
- Kohlbrenner K, Galuschek N, Fabarius A, et al. Blood. 2023;142(1):4539.
https://doi.org/10.1182/blood-2023-180730 - Daily life, support and chronic myeloid leukaemia (CML). (2025). Cancer Research UK. Accessed November 6, 2025.
https://www.cancerresearchuk.org/about-cancer/chronic-myeloid-leukaemia-cml/living-with/daily-life - Quintás-Cardama A, Kantarjian H, Jones D, et al. Blood.2009;113(25):6315–6321.
https://doi.org/10.1182/blood-2008-07-166694 - Geissler J, Sharf G, et al. J Cancer Res Clin Oncol. 2017;143:1167–1176.
https://doi.org/10.1007/s00432-017-2372-z - Data on file. CABL001J12301 clinical study report (Week 48 analysis). Novartis Pharmaceuticals Corp; 2022.
- Data on file. CABL001J SCS/RMP. Novartis Pharmaceuticals Corp; 2024.
Novartis Pharmaceuticals Corporation
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