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BLAST: Blinatumomab may effectively combat minimal residual disease in ALL

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SAN FRANCISCO — About 80% of patients with acute lymphoblastic leukemia experienced a minimal residual disease response after treatment with blinatumomab, according to study results.

Persistent minimal residual disease leads to poor prognosis in ALL, researcher Nicola Gokbuget, MD, head of the Study Center at Goethe University Hospital in Frankfurt, Germany, said during a presentation.

“These patients are essentially resistant to regular chemotherapy drugs,” she said. “Our goal is to achieve a molecular remission and avoid relapse. We should not forget about patients who can’t get a transplant.”

Blinatumomab (Blincyto, Amgen) is an investigational bispecific T-cell engager antibody construct that directs cytotoxic T cells to CD19-positive cells.

The analysis conducted by Gokbuget and colleagues included 116 patients from several European countries. All patients had B–precursor ALL in complete hematological remission. They received one cycle ff the study drug at 15 µg/m² per day for 28 days per cycle.

Complete minimal residual disease response served as the primary endpoint. Adverse events also were reported.

Results from the primary endpoint set of 113 patients indicated a complete minimal residual disease response rate of 78% (95% CI, 69-85) after one cycle. For an exploratory endpoint of minimal residual disease response after one cycle, the response was 85% (95% CI, 77-91).

Results from an efficacy analysis set of 103 patients indicated an 80% (95% CI, 71-87) complete minimal residual disease response rate and an 85% (95% CI, 77-92) minimal disease response for the exploratory endpoint.

“Responses occurred in all subgroups, including older patients and patients with high [minimal residual disease] level,” Gokbuget said. “No predictive factor for [minimal residual disease] response was identified.”

Two types of adverse events were reported.

“The first type are events correlated to cytokine release, which were observed in most patients,” she said. “Most cases were only grade 1 to grade 2.”

Ninety percent of patients experienced pyrexia, and about one-quarter of patients experienced chills and fatigue.

“The most commonly occurring adverse events were flu-like symptoms associated with T-cell activation,” Gokbuget said.

The other type of adverse events were neurologic, Gokbuget said. The most frequently occurring neurologic events were tremor and aphasia. 

For more information:

Gokbuget N. Abstract 379. Presented at: ASH Annual Meeting and Exhibition; Dec. 5-9, 2014; San Francisco.

Disclosure: Gokbuget reports associations with Amgen.