Blincyto Increases Survival of ALL Children, Adolescents After First Relapse, Phase 3 Trials Show

Blincyto (blinatumomab) increases overall survival and disease-free survival in children and adolescents with B-cell acute lymphoblastic leukemia (ALL) who already had their first relapse, data from Phase 3 trials show.

Blincyto, developed by Amgen, is an antibody that binds to CD19, a protein found on the surface of certain malignant B-cells, as well as to CD3, a protein found on the surface of immune T-cells. It works by bringing together T-cells and malignant B-cells, helping the T-cells recognize and destroy the cancer cells.

The treatment is approved in the U.S. for treating children and adults with relapsed or refractory ALL, and for those who are in remission but still have minimal residual disease – leftover cancer cells that can’t be detected with conventional methods.

A global, multi-center, randomized, open-label, Phase 3 trial (NCT02393859) is assessing the event-free survival following treatment with Blincyto in a group of children with high-risk ALL who already had their first relapse, compared to conventional consolidation chemotherapy.

New data from a pre-specified interim analysis of the study showed the trial met its primary goal of event-free survival, with children taking Blincyto living longer without disease progression or complications than those on chemotherapy.

An independent Data Monitoring Committee (DMC) recommended patient enrollment to stop early, based on the promising efficacy seen in children who received Blincyto. The DMC also recommended the trial should proceed without alterations to its clinical design.

Another randomized, Phase 3 trial (NCT02101853) also is evaluating the effects of Blincyto in children with low, intermediate or high-risk relapsed ALL who already had their first relapse, compared to intensive chemotherapy.

The trial, which has been sponsored by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) and conducted by the Children’s Oncology Group (COG), also closed patient enrollment into its intermediate and high-risk groups following a recommendation from the COG’s DMC.

The decision to stop patient enrollment ahead of schedule was based on preliminary findings showing that Blincyto led to stronger improvements in children’s overall survival and disease-free survival, with lower toxicity and better clearance of minimal residual disease, when compared to intensive chemotherapy.

The COG committee also stated that patient accrual should continue in the low-risk group until the initial target enrollment goal is met. In this group, researchers are comparing chemotherapy to a combination of chemotherapy and Blincyto.

Adverse side effects reported in both Phase 3 trials were consistent with the known safety profile of Blincyto.

“Considered together, the results of these studies are remarkable. Children and adolescents who relapse with acute lymphoblastic leukemia face a poor prognosis and there remains a need for additional treatment options, particularly for those that are identified as high-risk. These data have the potential to be practice-changing and may provide a treatment approach to prevent further relapse that is superior to chemotherapy,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a press release.

“We look forward to discussing these data with regulatory authorities,” Reese said.

Amgen is planning to present interim findings from both trials at an upcoming meeting and submit the data for publication in a medical journal.