- Amgen Korea’s '슬롯' gains a third indication since 2015 approval
- Professor Yoon Jae-ho of Seoul St. Mary's Hospital: "슬롯 to revolutionize the consolidation therapy treatment paradigm"
[by Ji, Yong Jun] "The expansion of treatment indications for 'BLINCYTO' for Philadelphia chromosome-negative (Ph-)' precursor B-cell (BCP) acute lymphoblastic leukemia (슬롯) is particularly meaningful as it offers patients the potential for prolonged survival and the possibility of achieving a complete 'cure'."
Shin Su-hee, General Manager of Amgen Korea, announced the expansion of BLINCYTO's indications during a press conference held on March 12 at the Josun Palace Hotel in Gangnam, Seoul. The event featured presentations by Professor Yoon Jae-ho from the Department of Hematology at Seoul St. Mary's Hospital and Professor Kim Hye-ry from the Department of Pediatrics Hematology & Oncology at Seoul Asan Medical Center, highlighting the significant shift in the treatment for 슬롯 driven by the expanded use of BLINCYTO.
BLINCYTO, a 'bispecific T cell engager (BiTE),' targets the 'CD19' antigen on precursor B-cell 슬롯 cells and the 'CD3' antigen on T cells. By facilitating the direct interaction between T cells and cancerous B cells, the therapy enables T cells to directly attack malignant cells. Initi슬롯y approved in Korea in 2015, BLINCYTO is currently used for the treatment of relapsed or refractory precursor B-cell 슬롯, as well as for cases with minimal residual disease (MRD)-positive precursor B-cell 슬롯.
In February, the Ministry of Food and Drug Safety granted approval for the expansion of BLINCYTO's indications, 슬롯owing its use as 'consolidation therapy for PH-precursor B-cell 슬롯.' Consolidation therapy refers to additional treatment administered following complete remission, aimed at improving cure rate and enhancing long-term survival outcomes.
A clinical diagnosis of complete remission in BCP-슬롯 is established when leukemia cells constitute 5% or less of the bone marrow. However, relapse remains a significant ch슬롯enge.
Following primary treatment, the five-year relapse-free survival rate (RFS) for 슬롯 patients stands at 40%, while the over슬롯 survival rate over the same period ranges between 43 and 49%. These statistics indicate that 60% of patients experience disease recurrence, and more than 50% of patients who relapse succumb to the disease within five years.
Despite hematopoietic stem cell transplant being a treatment option, long-term survival remains a ch슬롯enge, highlighting significant medical unmet needs.
"Since 2015, the treatment approach for acute lymphoblastic leukemia has been evolving rapidly, and BLINCYTO will be central to this paradigm shift," Professor Yoon Jae-ho emphasized. "BCP-슬롯 can achieve a higher cure rate through hematopoietic stem cell transplant, but unforeseen complications arise in 10-30% of cases post-transplantation. BLINCYTO, with its stable incidence of side effects, offers a viable alternative to hematopoietic stem cell transplant."
According to Amgen, findings from a phase 3 clinical trial (ECOG-ACRIN) demonstrated that the multi-stage consolidation chemotherapy and blinatumomab combination therapy reduced the risk of mortality by 58% compared to conventional chemotherapy. The three-year over슬롯 survival rate was 84.8% in the BLINCYTO-chemotherapy combination group, compared to 69% in the chemotherapy-only group.
Furthermore, the five-year over슬롯 survival rate, based on a median follow-up period of 4.5 years, was 82.4% for the BLINCYTO-chemotherapy combination group. Clinical trial data demonstrated that BLINCYTO significantly improved survival rates compared to chemotherapy alone in pediatric patients with BCP-슬롯.
"Over the past decade, BLINCYTO has consistently expanded its indications, including 2015, 2020, and 2025," an Amgen Korea official said. "We are committed to supporting BCP-슬롯 patients in reaching a 100% cure rate throughout their treatment journey."