This article was originally published by Targeted Oncology 

During a virtual Case Based Peer Perspective event, Jonathon B. Cohen, MD, MS, the codirector of the Lymphoma Program, medical director of Infusion Servies, and associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine and Winship Cancer Institute, discussed a case of a 71-year-old woman diagnosed with chronic lymphocytic leukemia.

Targeted Oncology™: What are reasonable treatment options to consider in a patient with CLL?

COHEN: The National Comprehensive Cancer Network guidelines offer 6 treatment options for patients with del(17p).¹ As I tell my fellows when I work with them, if you ever see a list of preferred regimens with 6 options, that likely means that nobody really knows what the best option is.

The 1 option not listed in the guideline is chemotherapy, especially in the relapsed setting for patients with del(17p). I generally would not use chemotherapy.

The only exception to that might be a situation where we have a patient who’s young and for whom we’re thinking about moving on to something like an allogeneic transplant or some other definitive therapy. We might consider using chemotherapy for a cycle or 2. But otherwise, if you’re not going in that direction, that’s the 1 thing we do feel comfortable saying—that is, that chemotherapy is probably not the right option.

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This article was originally published by AJMC

Adaptive Biotechnologies received its third approval from the FDA for the use of its next-generation sequencing assay to detect minimal residual disease (MRD) in chronic lymphocytic leukemia (CLL).

The assay, clonoSEQ, uses a proprietary immunosequencing platform to monitor for MRD, where a small number of cancer cells remain during and after treatment. It is difficult to detect without precise, sensitive tools, and can lead to a recurrence of disease.

The approval follows a decision by CMS in January to pay for cloneSEQ testing for CLL, in addition to multiple myeloma and B-cell acute lymphoblastic leukemia. Nearly 80% of US patients with CLL are age 65 or over.

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This article was originally published by Pharmacy Times 

Chronic lymphocytic leukemia (CLL) is a cancer of the blood and bone marrow that can be treated to extend the life of some patients even by decades. Treatments and best practices are developing rapidly and health care providers need to stay up to date on all relevant information. In a Pharmacy Times Insights video series, a panel of experts discussed how to best treat and monitor patients living with CLL.

The panel included Alison Duffy, PharmD, BCOP, an associate professor and clinical pharmacy specialist in oncology at the University of Maryland School of Pharmacy and Cody Steeves, PharmD, BCOP, a clinical pharmacist for Biologics by McKesson.

Both intravenous (IV) and oral CLL medications are available, each with their own benefits and disadvantages. A combination method is also used by many patients, but that also presents a unique set of challenges.

“Some of the economic challenges we’ve seen have been the timely approval of the oral and the IV therapy together because of pharmacy benefits and medical benefits, and so that can be a challenge, especially if a patient’s disease is very aggressive. If they have progressed on ibrutinib it would be really important to start their subsequent therapy very quickly, or it can progress to Richter transformation,” Duffy said. “The economic challenges in improving can be a barrier. As pharmacists, anything we can do to facilitate the approval process, and in the clinic, I can certainly help with the prior authorization process.”

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This article was originally published by Pharmacy Times

In the Pharmacy Times ® Directions in Oncology™ Insights series on chronic lymphocytic leukemia (CLL), experts Alison Duffy, PharmD, BCOP, and Cody Steeves, PharmD, BCOP, discussed current treatment recommendations and what is next for the disease state.

CLL is a rare cancer of the blood and bone marrow, and although it is difficult to treat many advances have been made in the past 6 years, said Duffy, an associate professor, clinical pharmacy specialty in oncology at the University of Maryland School of Pharmacy.

Earlier recommendations included single-agent chemotherapy or single-agent monoclonal antibodies, but Duffy explained that patients are increasingly receiving small molecule inhibitors, including Bruton tyrosine kinase (BTK) inhibitors.

Without the use of single-agent chemotherapies or single-agent monoclonal antibodies, Duffy said pharmacists can see patients with CLL in many settings.
“Using those as single agents, or more commonly in combination, that’s where the pipeline and future directions are really moving towards, with combination therapy as well as more potent, more selective, targeted therapies,” she said.

According to recommendations from the National Comprehensive Cancer Center (NCCN), Duffy said some current frontline treatment agents include ibrutinib, venetoclax plus obinutuzumab, acalabrutinib with or without obinutuzumab, and chemo-immunotherapy, when warranted.

Frontline therapies present various challenges, although Duffy said the treatment criteria has become less rigid.

“Some of the things that I would think about would be age, fitness, comorbidities such as atrial fibrillation, and renal function if I was going to give something like fludarabine within the FCR [fludarabine, cyclophosphamide, and rituximab] regimen,” Duffy said.

She added that considering patient preferences and clinical experiences is important. Some patients may not be great candidates for oral therapy due to a lack of access, finance, comfort level, or adherence challenges. Similarly, transportation might be an issue for patients receiving intravenous chemotherapy and should be considered.

“Moving forward, it’s positive to see that the outcomes, when they’re stratified by those patients with the deletions, still tend to trend in the positive direction for those patients with these newer oral therapies we’ve had over the past 5 or 6 years,” Steeves said.

The experts also turned their attention to minimum residual disease (MRD) testing and how it affects the use of limited duration therapy. MRD testing is particularly helpful for diseases that require stronger treatments, Steeves said. He explained that some data has found that obtaining a low or negative MRD corresponds with significantly increased progression-free survival compared with medium or high levels of MRD. However, patients receiving oral agents, especially single-agent BTK inhibition alone or with a CD20 inhibitor, are not expected to achieve MRD. Despite the lack of MRD, Steeves said these agents can be valuable.

“Even though we’re not seeing those deep remissions with MRD negativity, undetectable MRD, we certainly are still seeing a large benefit of using these agents without that,” Steeves said.
Steeves, clinical oncology pharmacist, Biologics by McKesson, also emphasized the importance of a patient-specific treatment plan. Some patients may want to take the drug for as short a period as possible, while others find that it does not disrupt their daily lives to a large extent because they are already receiving multiple medications.

Finally, Duffy and Steeves turned their attention to BTK inhibitor monotherapy for patients with newly diagnosed CLL. Ibrutinib, a new BTK inhibitor, was investigated in the RESONATE trial (NCT01578707), which found long-term benefit of the drug upon 6-year follow-up. The trial also established ibrutinib as the first-line choice for older patients and those without a 17P deletion, thereby demonstrating significant progression-free survival benefit among those high-risk subgroups. However, Duffy noted that ibrutinib is not for everybody.

“If you have a patient with uncontrolled atrial fibrillation, who has a high risk of bleeding that can’t be mitigated, or uncontrolled hypertension despite optimizing therapy management, ibrutinib wouldn’t be my first choice,” Duffy said.

Although the various treatments all need to be evaluated based on unique patient needs, the recent developments for the treatment of CLL are very promising and exciting, Duffy concluded.
“We’re getting to have a better understanding of CLL biology and some of the prognostic indicators,” Duffy said. “These new therapies allow for treatment without some of the traditional chemotherapy agents.”

THE PHARMACY TIMES® DIRECTIONS IN ONCOLOGY™ INSIGHTS SERIES ON CLL CAN BE VIEWED AT WWW.PHARMACYTIMES.COM/INSIGHTS.