This drug combination keeps young individuals with chronic lymphocytic leukemia (CLL) from coming back for years, says new study.

Young people with chronic lymphocytic leukemia (CLL) who take the drug ibrutinib can have long remissions, but they must take it permanently to keep the malignancy at bay.

A new study suggests that a 2.5-year regimen comprising ibrutinib and chemoimmunotherapy can result in deep and long-lasting remissions of the disease.

The findings, which will be presented at the 63rd American Society of Hematology (ASH) Annual Meeting, update preliminary data from a study of the regimen in 85 patients with previously untreated CLL that was published in 2019.

Nearly all of the patients were in remission at 16.5 months, and the latest data show that the benefits are still being felt at a median of 40.3 months.

“Patients with lower-risk CLL, which is marked by mutated IGHV genes, can gain long remissions from a six-month regimen known as FCR – for the chemotherapy drugs fludarabine and cyclophosphamide and the antibody therapy rituximab,” says Matthew Davids. 

Patients with higher-risk CLL who do not have an IGHV mutation do not usually benefit as much from FCR. They can benefit from ibrutinib, but they must take it for the rest of their lives, which can be difficult for younger patients due to the drug’s dangers and side effects.

“Our study examined whether a time-limited course of ibrutinib given in combination with FCR can provide lasting remissions for patients with CLL regardless of whether they have the IGHV-mutated or -unmutated subtype.” 

The trial involved 85 CLL patients aged 65 and under. The more aggressive, unmutated IGHV subtype was found in 46 of them. Ibrutinib, a targeted medicine that disables an enzyme used by CLL cells to survive, was given to patients for seven days, followed by a combination of ibrutinib and FCR for up to six months. Patients were subsequently given ibrutinib alone for another two years, and those who had no detectable leukemia cells in their bone marrow at the end of that time were told to stop taking it.

With a median follow-up of 40.3 months, the current study found that 99 percent of the patients were alive, and 97 percent were living with no deterioration of their condition. Those figures are basically unchanged from the study’s early analysis, which included a 16.5-month follow-up.

The few patients whose disease returned after 2.5 years reacted well to resuming ibrutinib treatment.

The side effects of the combined therapy were generally tolerable and were similar to those seen with ibrutinib and FCR alone.

“We’re very encouraged about the potential of this therapy to generate long-term remissions in a broad population of younger patients with CLL,” Davids added. 

“For young patients, in particular, who, hopefully, have decades of life ahead of them, the prospect of a time-limited therapy that can have such durable impact without the need for ongoing treatment is very impactful.” 

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