Blinatumomab Plus Chemotherapy New Standard for Children With B-Cell ALL

The randomized phase III AALL1731 trial presented at the American Society of Hematology annual meeting showed that adding the bispecific T-cell engager blinatumomab (Blincyto) to chemotherapy significantly improved disease-free survival for children with newly diagnosed B-cell acute lymphoblastic leukemia (ALL).

In this exclusive MedPage Today video, Rachel Rau, MD, of the University of Washington and Seattle Children’s Hospital, offers a summary of the study’s results.

Following is a transcript of her remarks:

The study I presented today was AALL1731, which was a phase III study run by the Children’s Oncology Group. And the portion of the trial I presented was the randomized portion where patients at average or higher risk of relapse were randomized to either standard chemotherapy alone or that same chemotherapy backbone plus two cycles of blinatumomab.

The results of that trial revealed that blinatumomab added to chemotherapy significantly improved disease-free survival for patients. Our overall randomized cohort had a 3-year disease-free survival of 96% for those who received blinatumomab compared to 87.9% for those randomized to receive chemotherapy alone.

The improved disease-free survival was secondary to a significant reduction in bone marrow relapses. And, overall, blinatumomab in the trial was very well tolerated. We saw low rates of known toxicity with blinatumomab, including cytokine release syndrome and neurotoxicity, including seizures and encephalopathy. And while infectious toxicities overall were relatively rare, we had an increased risk of grade 3+ sepsis and catheter-related infections amongst our standard-risk average patients who received blinatumomab.

Overall, our trial demonstrates that blinatumomab added to chemotherapy is now a standard therapy for patients with NCI [National Cancer Institute] standard-risk B-cell ALL. And, more broadly speaking, this added to other data presented recently revealed that blinatumomab is a standard component of therapy for most patients with B-cell ALL.

So, there are already published studies that revealed that the addition of blinatumomab to chemotherapy improved outcomes for infants with B-cell ALL, and adults with B-cell ALL. But this trial specifically showed that for children with standard-risk ALL, blinatumomab should be considered a standard component of therapy.

I think it’s safe to extrapolate to another population of patients called NCI-high-risk B-ALL, a group that’s enriched for adolescents. Those patients are also likely to benefit when you combine our results with adult results. And so, overall, blinatumomab should be considered a standard part of therapy for pretty much all patients with B-cell ALL.

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