Amgen Korea said Tuesday that it has received approval from the Ministry of Food and Drug Safety (MFDS) for its acute lymphoblastic leukemia (ALL) drug Blincyto (blinatumomab) to expand its indication as consolidation therapy for Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL).

Patients with Ph-negative BCP ALL have a high unmet medical need, as they frequently relapse despite achieving MRD-negativity through remission induction with conventional chemotherapy and have difficulty achieving long-term survival after hematopoietic stem cell transplantation.

With this approval, Blincyto is available for up to four cycles as consolidation therapy in adult and pediatric patients with Ph-negative BCP ALL. Blincyto was previously approved for treating relapsed or refractory B-cell ALL and microscopic residual disease (MRD)-positive B-cell ALL.

Blincyto's expanded indication is based on results from the E1910, AALL1731, AALL1331, and 20120215 studies. In the E1910 study, which compared chemotherapy alone vs. Blincyto in combination with chemotherapy as consolidation therapy after induction in adult patients with BCP 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 crossover arm demonstrated a 59 percent reduction in the risk of death over a median follow-up of 43 months (HR: 0.41; 95 percent Cl, 0.23-0.73; P=0.002).

Besides, the three-year recurrence-free survival (RFS) rate was 80 percent in the Blincyto plus chemotherapy arm vs. 64 percent in the chemotherapy-alone arm, giving the Blincyto plus chemotherapy arm a 47 percent reduction in the risk of recurrence or death over a median follow-up of 43 months compared to chemotherapy alone (HR 0.53; 95 percent CI, 0.32-0.87).

In addition, in the AALL1731 study of MRD-negative pediatric patients with BCP ALL in the U.S. National Cancer Institute (NCI) Standard-risk (SR) category who were at average or high risk of relapse, 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 a new treatment option to pediatric and adult patients with first-line ALL who are at risk of relapse,” Amgen Korea General Manager Shin Su-hee said.

Blincyto is the first bispecific T-cell engager (BiTE) that simultaneously engages T-cells and cancer cells. It binds to the CD3 protein on T-cells and the CD19 protein on leukemia cells to direct immune cells to attack cancer cells.