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CML LINE TRIAL

Even if there is some reemergence of molecular disease, a lot of the time it just stays at a very low level and the leukemia lies dormant. Regardless of the TKI being looked at, or if itвЂ™s all TKIs that are being looked at, it all looks pretty similar about 50 percent of people can stop treatment and stay off treatment long term. The data I showed compared cytogenetic and molecular responses early on and then, over a five-year follow-up period, and looked at rates of progression to advanced phase CML and all of those studies.TKI discontinuation becoming more of a mainstream option is extremely exciting because weвЂ™ve had a wealth of discontinuation studies that have been published over the past five to eight years with data that are all very similar.

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The ENESTnd trial was the phase 3 study of Tasigna versus Gleevec upfront. The DASISION trial was a study looking at Sprycel, which is a second-generation TKI, compared with Gleevec in the frontline setting. Overall, what are some really exciting things on the horizon for CML? We now have long-term data from that study, that was published a couple of months ago with 10-year follow-up, which shows remarkable improvements in long-term survival in chronic-case patients with CML compared with the pre-Gleevec era looking at toxicities and things along those lines. IRIS was a phase 3 study of Gleevec versus the prior standard of care, which was interferon and cytarabine. What pivotal studies have led to the basis for what you use for frontline treatment?ДЇinally, the new term, вЂњTKI discontinuation,вЂќ suggests that there is a subset of patients who are likely to do very well when they have achieved a deep molecular response and we stop therapy.The three studies, which I showed today, were the IRIS trial, the DASISION trial and the ENESTnd trial. Monitoring according to the guidelines is necessary because there are certain mile stones that need to happen or be achieved in order to ensure long-term outcomes are favorable for these patients.

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What are the factors that need to be considered when making the decision on how to appropriately treat someone in the upfront setting? WeвЂ™re looking at things like risks scores, comorbidities and long-term goals, and then analyzing the data from all frontline studies to make a decision about how to best treat those patients.ДЄnother key point was the need for frequent monitoring in CML- not just starting someone on therapy and hoping for the best. Sweet discussed the various factors that must be taken into account when prescribing first-line therapies to patients with CML, the novel studies that are paving the way for improved outcomes in patients, and the increasing likelihood for TKI discontinuation on the horizon.One of the main points I brought up in my presentation was selection of firstline therapy for a newly diagnosed patient with CML. Can you give an overview of some of the main points in CML advances? вЂњNow that discontinuation is a real possibility for patients, monitoring becomes even more important because we want to maximize the chance that someone can actually get to that point and have that opportunity,вЂќ Sweet said in an interview with CURE. Once therapy is administered, it becomes necessary to monitor the patient on a continual basis to ensure long-term favorable outcomes. In order to increase the potential for treatment discontinuation, a new combination therapy approach might need to be taken - something that Sweet says is currently being explored. The common practice has been to keep a patient on TKI therapy indefinitely, but according to Sweet, an assistant member in the Department of Malignant Hematology at Moffitt Cancer Center, TKI discontinuation has been achieved and continues to be studied. Promising treatment options are in the pipeline for patients with newly diagnosed chronic myeloid leukemia (CML), as groundbreaking trials are highlighting the potential of tyrosine kinase inhibitors (TKIs), such as Gleevec (imatinib), Sprycel (dasatinib) and Tasigna (nilotinib), explains Kendra Sweet, M.D.

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