Krish Patel, MD, medical oncologist, Swedish Cancer Institute, discusses a study looking at the real-world benefit of BTK inhibitors in patients with mantle cell lymphoma (MCL) versus what has been seen in clinical trials.

Exploring the potential of BTK inhibitors in MCL was a major research focus at the 2018 ASH Annual Meeting. Researchers are starting to embrace the importance of this class of drugs in the relapsed/refractory setting, Patel says. One study compared responses to ibrutinib (Imbruvica) in the real-world setting with what is typically seen in clinical trials.

Overall response rates and median progression-free survival data were comparable, he notes, suggesting that real-world clinical benefit with BTK inhibitors can mirror what is seen in clinical trials. Results also showed that in the real-world setting, discontinuation rates were higher than what had been observed in clinical studies; that was primarily driven by disease progression. Importantly, about one-quarter of patients had to stop therapy with ibrutinib due to toxicities, Patel says. This is higher than what has been reported in clinical trials with ibrutinib, so this is an interesting outcome to consider, and one that requires further evaluation.

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Krish Patel, MD, medical oncologist, Swedish Cancer Institute, discusses a study looking at real-world benefit of BTK inhibitors versus what is seen in clinical trials for patients with mantle cell lymphoma.

Dr. Patel on Ibrutinib in Real-World Setting Versus Clinical Trials

Krish Patel, MD, oncologist, Swedish Cancer Institute, discusses the promise of acalabrutinib (Calquence) in the treatment of patients with mantle cell lymphoma (MCL).

In October 2017, the FDA approved the second-generation BTK inhibitor for the treatment of adult patients with MCL following at least 1 prior line of therapy. The approval was based on findings from the phase II ACE-LY-004 trial, in which the objective response rate (ORR) was 81% in those who received acalabrutinib. The complete response (CR) rate with acalabrutinib was 40% and the partial response rate was 41%. These data were first reported after 15 months of follow-up, Patel says.

At the 2018 ASH Annual Meeting, 2-year follow-up from the same study was presented, showing a sustained benefit with acalabrutinib. ORR was still over 80%, Patel notes, with about half of those patients achieving a CR. In addition, the toxicity profile seemed similar to what had been observed with the earlier follow-up. A total of 124 patients were enrolled in the study. Participants received 100 mg acalabrutinib twice daily.

Krish Patel, MD, oncologist, Swedish Cancer Institute, discusses the promise of acalabrutinib in the treatment of patients with mantle cell lymphoma.

Dr. Patel Discusses Promise of Acalabrutinib in MCL

Krish Patel, MD, oncologist, Swedish Cancer Institute, discusses differences between BTK inhibitors in mantle cell lymphoma (MCL).

It is well established that BTK inhibitors play a crucial role in the relapsed/refractory setting of MCL, says Patel. In 2013, the FDA approved ibrutinib (Imbruvica) for patients with MCL who have received at least 1 prior therapy. In 2017, the FDA approved acalabrutinib (Calquence) for patients with MCL who have progressed on at least 1 prior therapy.

Data presented at the 2018 ASH Annual Meeting pointed to subtle differences between those agents, especially with regard to safety, says Patel. As it stands, BTK inhibitors are given continuously. Toxicity data and overall rate of therapy continuation are important pieces of information that can help clinicians distinguish between the 2 inhibitors, he adds.

Moving forward, these agents should be studied in randomized clinical trials with equivalent patient populations. That way, if there are differences observed between them, investigators can be confident that they are due to the medication and not the design of the clinical trial or the patient populations included.

Dr. Patel on Differences Between BTK Inhibitors in MCL

Krish Patel, MD, oncologist, Swedish Cancer Institute, discusses induction therapy with bendamustine and rituximab (Rituxan; BR) in the treatment of patients with mantle cell lymphoma (MCL).

At the 2018 ASH Annual Meeting, an abstract was presented on induction therapy with BR. Investigators assessed response rates, progression-free survival, and overall survival. Data were pulled from two phase II studies as well as from patients who had been treated off trial. BR was given for a total of 3 cycles, and if patients achieved a clinical response, they went on to receive 3 cycles of rituximab and cytarabine. This was followed by an autologous stem cell transplant.

This is an important study, states Patel, as the optimal induction regimen for newly diagnosed patients is unknown. Though there are many potential induction regimens from which to choose, the study provides compelling evidence that the combination of these agents is something to pursue in future trials.

Krish Patel, MD

Articles

Dr. Patel on Ibrutinib in Real-World Setting Versus Clinical Trials

Dr. Patel Discusses Promise of Acalabrutinib in MCL

Dr. Patel on Differences Between BTK Inhibitors in MCL

Dr. Patel on Induction Therapy With Bendamustine and Rituximab in MCL