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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

Navtemadlin, a novel MDM2 inhibitor, demonstrated potential in treating relapsed or refractory myelofibrosis in the phase 3 BOREAS trial.

Navtemadlin Monotherapy Shows Improvements in Hallmarks of R/R Myelofibrosis 

Asciminib has gained accelerated approval from the FDA for the treatment of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

FDA Approves Asciminib in Newly Diagnosed Ph+ CML in Chronic Phase

Careful management by a team of specialists is needed to balance disease control and fetal health in patients with CML who are pregnant or trying to become prengant. 

Treating the Patient With CML Who Is Pregnant or Trying to Become Pregnant

Ongoing research is exploring new molecular targets and targeted therapies for this challenging disease.

Atypical Chronic Myeloid Leukemia: A Rare Disease With Poor Prognosis

Moving TKIs to the Front-Line in CML-CP Requires Improved OS and Cost-Effective Strategies

Elisabetta Abruzzese, MD of S. Eugenio Hospital, discusses the management of pregnancy in patient with chronic myeloid leukemia (CML).

 has changed drastically over the past 10 years. There are 2 cases that clinicians should be aware of, when a patient is pregnant and discover CML and the other when a patient has CML and gets pregnant during treatment.

Tyrosine kinase inhibitors (TKIs) should been stopped at the first positive pregnancy test, as they are teratogenic, according to Arbuzzese. This means that the development of fetal organs can be impacted. There use is especially dangerous during the fifth through the tenth week of gestation. TKIs should be stopped around the fourth week of gestation.

 The management of pregnancy in CML has changed a lot in the past 10 years. We now have some recommendations that can help clinicians get through this. We basically distinguish among the 2 main topics, which are patients that get pregnant and discover CML while they are pregnant and patients with CML already treated for CML, who get pregnant during treatment. Depending on what kind of situation a physician has, there are different approaches they can take.

Generally, TKIs that are the main drug that can be used in in CML patients must be stopped at first pregnancy tests because they can be toxic and are teratogenic. This means that they can impact on the on the organs and fetal development, especially during the first week of pregnancy. The teratogenesis is the most dangerous during the fifth until the tenth week of gestation. This means that a TKI can be used until the first pregnancy test turn positive around the fourth week of gestation and must be stopped around the fifth and the sixth week that are the most dangerous. But 2 of those drugs mainly, imatinib [Gleevec] and nilotinib (Tasigna) pass poorly in the placenta and this means that after the 16th week of gestation when organogenesis has ended, and placenta is formed, if necessary, they can be used again to prevent progression of the CML.

Videos

Elisabetta Abruzzese, MD of S. Eugenio Hospital, discusses the management of pregnancy in patient with chronic myeloid leukemia. 

News

Managing Pregnancy in Patients With CML

Moshe Levy, MD, the director of Hematologic Malignancies Research at Texas Oncology- Baylor Charles A. Sammons Cancer Center, discusses the ongoing phase 3b study of single-agent asciminib for the treatment of patients with chronic myeloid leukemia in chronic phase (CML-CP) who may or may not harbor 

Asciminib is an investigational BCR-ABL1 inhibitor that directly targets STAMP. In early-phase studies, the agent demonstrated promising efficacy and safety in patients with CML-CP who were resistant or intolerant to other tyrosine kinase inhibitors (TKIs) having failed at least 2 prior lines of therapy.

The AIM2CML clinical trial (NCT04666259) is further investigating the efficacy and safety of the drug in this patient population.

 The big take home message here is that this is a tyrosine kinase inhibitor that works differently than our current tyrosine kinase inhibitors that are currently on the market. So, in the US, we have 5 commercially approved TKIs, imatinib [Gleevec] anlotinib [AL3818], dasatinib

[Sprycel], bosutinib [Bosulif], and ponatinib [Iclusig]. And these are all what's called ATP competitive TK eyes. And this is what's called an allosteric inhibitor. So, it has a completely different binding sites.

 I think what's most exciting about this particular therapy, actually, there's 2 things that I am particularly excited about. So, the first one is the profile of this drug seems to be fantastic in the preliminary data that has been seen so far. Furthermore, the efficacy is also fantastic. So, we have not seen any kinase domain mutations that confer resistance to this therapy. So, it makes it an attractive option for folks, you know, with the 

 mutation for which only ponatinib works in terms of TKIs currently available, but the tolerability profile, you know, and the efficacy profile lends itself to being used in a variety of resistant chronic myelogenous leukemias.

 Furthermore, and this is extrapolating further down the road. This mechanism of action can be complimentary with the use of these ATP competitive TKIs and hopefully the combination may lead to durability, and more people will be cured and be able to discontinue therapy.

Moshe Levy, MD discusses the ongoing phase 3b study of asciminib in patients with chronic myeloid leukemia in chronic phase.

Exploring Asciminib Monotherapy in CML-CP +/- T315I Mutations

Jorge E. Cortes, MD, director of the Georgia Cancer Center at Augusta University, discusses the current therapies available to treat patients with chronic myeloid leukemia (CML) and how to choose between them when there is similar efficacy.

Multiple tyrosine kinase inhibitors (TKIs) are available in this setting, as well as other types of drugs that have been approved recently. Cortes feels that when deciding between 2 drugs that had comparable results for patients with CML, going by the individuals’ comorbidities and other unique factors can help find the best option for that patient.

 We currently have a good number of drugs. This is where there are so many good options. We have 5 TKIs, and then of course, we have omacetaxine (Synribo), that's approved. But there are still some patients that are not having the outcomes that we want. There are still some issues with toxicity with some of the existing drugs. So as much as we would like to think that all patients do well, actually, if you look at some of the statistics from the frontline studies, by 5 years, 40% of patients are required to change therapy. So clearly, there is still a need for other treatment options. There are some scenarios where it's particularly relevant. For example, patients who've already gone to 2 or 3 TKIs, you start getting into not very effective therapies. Patients with a T315I mutation, we have 1 drug approved for that indication, and so on.

 A lot of the drug approvals have been with phase 2 data. We do have comparisons in the frontline setting. We've had trials comparing second generation (TKIs) to imatinib (Gleevec) and they do show benefit. So that that allows you to make those decisions. However, between the different second generation TKIs, only very recently, last year at ASH (American Society of Hematology), there was 1 study comparing dasatinib (Sprycel) to erlotinib (Tarceva). It was the first time ever that a second generation is compared to a second generation (TKI). It showed that efficacy-wise, it's completely identical.

 In the more advanced settings, we haven't had a randomized trial comparing 1 option versus another until asciminib. There is a randomized study of asciminib versus bosutinib (Bosulif) and it showed benefit. Bosutinib was a good control, they had no problem with the design of the study. However, a question that many of us are asking now is, if asciminib is approved, how do we decide between asciminib and ponatinib (Iclusig), which is the drug that we consider in that setting most of the time.

 So that leads me to the question, how do you make those decisions then, when you're facing these scenarios? I think what we what we tend to end up doing is matching patients according to their comorbidities, the safety profile of the drugs, and trying to use the drug that has the least effects on areas where the patient may be having problems. For example, if you have a patient with pulmonary problems, you may not want to use the dasatinib because there's more of a risk of pleural effusions, and so on. The schedule, sometimes that becomes important. There are drugs that are given once a day with or without food, and others that are twice a day and no food 2 hours prior and 1 hour after and it's a little more complicated, particularly for some patients, depending on their lifestyle, etc. So you use these kind of features to make those decisions when the efficacy either looks the same, or there's no direct comparison.

Jorge E. Cortes, MD, discusses the current therapies available to treat patients with chronic myeloid leukemia and how to choose between them when there is similar efficacy.

Exploring Current Therapeutic Options and Treatment Selection in CML

Michael J. Mauro, MD, a hematologist at Memorial Sloan Kettering Cancer Center, discusses the unmet needs of patients with chronic myeloid leukemia (CML) and what potential therapies are being investigated currently for this patient population.

Mauro believes there is still work to be done in the CML patient population, such as patients who are highly resistant to treatment. Many patients will go through multiple lines of tyrosine kinase inhibitor (TKI) therapy because of intolerance, resistance, or a mix of both. Right now, there are several therapies in development for these patients. Mauro believes the most notable is asciminib (ABL001), an investigational allosteric BCR-ABL inhibitor.

Patients with CML who progress to blast phase or patients who present with high-risk or advanced disease can be difficult to treat with TKIs only, according to Mauro, and so there needs to be a better cohesion between the conventional chemotherapy agents with the most effective TKIs to optimize treatment for patients with advanced-phase CML. The treatment algorithms still need to be rectified in this setting in regard to stem cell transplantation and long-term strategies so the community of physicians know how to best treat these patients, Mauro concludes.

<< View more resources and information regarding CML

Michael J. Mauro, MD, discusses the unmet needs of patients with chronic myeloid leukemia and what potential therapies are being investigated currently for this patient population.

Chronic Myeloid Leukemia

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