Blincyto (blinatumomab), a treatment for acute lymphoblastic leukemia (ALL), is approved for an expanded indication as a consolidation therapy. Its role in clinical settings will be broadened.

Experts view that having more treatment options is favorable, as the consolidation therapy option has been limited following the first-line treatment of B-precursor ALL until now.

On March 12, Amgen hosted a press conference celebrating the approval of an expanded indication for Blincyto as a consolidation therapy to treat B-precursor ALL. The company highlighted the potential role of the drug.

On the 14th of last month, the Ministry of Food and Drug Safety (MFDS) granted approval of indication for Blincyto as a consolidation therapy for Philadelphia chromosome-negative (Ph-negative) B-precursor ALL.

The approval broadened the treatment area of the drug from treating adults with relapsed or refractory B-cell precursor ALL with minimal residual disease (MRD) to treating adults of young children with Ph- B-cell precursor ALL as a consolidation therapy up to Stage 4.

Patients with Ph- B-cell precursor ALL are known to relapse often despite reaching MRD negative through remission induction therapy using existing chemotherapy.

Patients with ALL may experience difficulties in long-term survival despite undergoing stem cell transplantation. Therefore, ALL still has high unmet needs.

Approval of a new indication for Blincyto as a consolidation therapy for patients who already had induction therapy using existing chemotherapy has gained attention since it was based on clinical data demonstrating statistically significant effects on patients diagnosed early or who relapsed.

According to the E1910 clinical study results, administering Blincyto as the first-line consolidation therapy after chemotherapy to adult patients (n=112) with B-precursor cell ALL who had MRD-negative remission (<0.01%) resulted in 3-year overall survival (OS) of 85%, which is higher than a 68% OS in the chemotherapy-alone treatment group (n=112).

Dr. Jae-Ho Yoon, Professor in the Department of Hematology at Seoul St. Mary's Hospital, commented regarding this, "Previously, chemotherapy or stem cell transplantation were the only treatment options that can be used as a consolidation therapy for the first complete remission stage after the first-line treatment in B-precursor cell ALL treatment," adding, "The E1910 clinical data results are highly favorable since a new treatment option with demonstrated effects in reducing the risk of relapse and improving survival rate has been presented."

Dr. Yoon believes that Blincyto will bring a paradigm shift in the treatment of ALL without the need for stem cell transplantation.

"As B-precursor ALL progresses quickly and has a high risk of relapse, a consolidation therapy using Blincyto, a very safe treatment option for managing the risk of relapse for ALL, will provide significant therapeutic benefits," Dr. Yoon said.

Dr. Hyery Kim, a Professor in the Department of Pediatrics at Asan Medical Center in Seoul, also expected the potential role of Blincyto in ALL treatment in young children.

Dr. Kim highlighted the results of the AALL1731 clinical study, which involved children with newly diagnosed B-precursor cell ALL

The study involved children with B-precursor cell ALL who had an average or higher risk of MRD-negative remission (n=1140 patients).

The study results showed that at the median 2.5 years of follow-up, the treatment group undergone Blincyto and chemotherapy switching (n=718 patients) had 96.0% 3-year disease-free survival (DFS) rate, which is a significant improvement compared to 87.9% of the chemotherapy-alone treatment group (n=722 patients).

"Treatment options for children with ALL have been limited to the traditional chemotherapy for the past 20 years; thus, there has been consistent demand for a new treatment option," Dr. Kim said. "Blincyto consolidation therapy, a consolidation therapy that can overcome the limitations of existing chemotherapy-based standard therapy, is expected to provide a new possibility of full recovery for children with ALL."