Blincyto (blinatumomab) for acute lymphoblastic leukemia (ALL) has received an expanded indication from the U.S. Food and Drug Administration (FDA) for the consolidation treatment of Philadelphia chromosome-negative (Ph-) progenitor B-cell acute lymphoblastic leukemia.

Blincyto can now be used as consolidation therapy for adult and pediatric Philadelphia chromosome-negative pro-lymphoblastic ALL patients with relapsed or refractory pro-lymphoblastic ALL, as well as for the previously approved treatment of microscopic residual disease (MRD)-positive pro-lymphoblastic ALL in Korea.

Amgen Korea said Friday that it has received approval from the Ministry (MFDS) to use Blincyto as consolidation therapy in adult and pediatric patients with Philadelphia chromosome-negative promyelocytic B-cell ALL. This allows for up to four cycles of treatment in adult and pediatric patients.

Patients with progenitor B-cell Philadelphia-negative ALL frequently relapse despite achieving MRD-negativity through remission-induction therapy with conventional chemotherapy. The disease remains a high unmet medical need, with patients struggling to achieve long-term survival after hematopoietic stem cell transplantation.

Blincyto is the world's first bispecific T-cell engager designed to simultaneously bind to surface proteins on immune cells, T-cells, and tumor antigen proteins on cancer cells. It simultaneously binds the CD19 protein, expressed on precursor B-cell acute lymphoblastic leukemia cells, and the CD3 protein, expressed on T-cells, to help T-cells attack leukemia cells.

Blincyto’s approval expansion is based on the results of the E1910, AALL1731, AALL1331, and 20120215 studies.

In the E1910 study, which compared chemotherapy alone versus Blincyto in combination with chemotherapy as consolidation therapy after induction in adult patients with promyelocytic B-cell ALL, the three-year overall survival (OS) in the Blincyto plus chemotherapy arm was 85 percent vs. 68 percent in the chemotherapy-alone arm in MRD-negative patients.

Compared to chemotherapy alone, the Blincyto plus chemotherapy combination showed a 59 percent reduction in the risk of death over a median follow-up of 43 months.

In addition, the three-year recurrence-free survival (RFS) rate was 80 percent in the Blincyto plus chemotherapy arm and 64 percent in the chemotherapy-alone arm, resulting in a 47 percent reduction in the risk of recurrence or death in the Blincyto plus chemotherapy arm over a median follow-up of 43 months compared to chemotherapy alone.

In the AALL1731 study of MRD-negative patients at average or high risk of relapse in pediatric patients with the U.S. National Cancer Institute (NCI)’s standard-risk pre-B-cell ALL, the estimated three-year disease-free survival at a median follow-up of 2.5 years was 96.0 percent in the Blincyto plus chemotherapy arm compared to 87.9 percent in the chemotherapy-alone arm, a significant improvement.

Based on these findings, the 2024 U.S. National Comprehensive Cancer Network (NCCN) guidelines recommend a regimen that includes Blincyto as first-line consolidation therapy.

“We are excited to offer this new treatment option to pediatric and adult patients with first-line ALL who are still at risk of relapse despite conventional chemotherapy,” Amgen Korea CEO Shin Su-hee said. “With the expansion of Blincyto's approval for consolidation therapy, we will continue to do our best to prevent ALL’s relapse.”

Blincyto was previously approved in the U.S. in June 2016 for the consolidation treatment of CD19+ Philadelphia chromosome-negative promyelocytic B-cell acute lymphoblastic leukemia in children and adults 1 month of age and older.