Amgen announced data from a phase 3 study that found blinatumomab showed prolonged event-free survival compared to consolidation chemotherapy in patients with relapsed acute lymphoblastic leukemia.
When compared with consolidation chemotherapy, blinatumomab (Blincyto) demonstrated a significantly prolonged event-free survival (EFS) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (ALL), according to an Amgen press release.
The data from the randomized phase 3 20120215 study (NCT02393859), published recently in JAMA, evaluated the efficacy, safety, and tolerability of blinatumomab versus chemotherapy before allogeneic hematopoietic stem cell transplantation.
"Acute lymphoblastic leukemia is the most common type of cancer in children. Unfortunately, approximately 15% of children with high-risk B-ALL relapse after frontline chemotherapy," David M. Reese, MD, executive vice president of research and development at Amgen, said in a press release. "There remains an urgent need for novel treatment options for these patients, and the study results support Blincyto as a new standard of care consolidation therapy for patients with this aggressive disease."
When examining the data at a median follow-up of 22.4 months, the research team found that 69% of patients treated with blinatumomab were alive and event free compared to only 43% of patients treated with chemotherapy.
More, 93% of patients with minimal residual disease (MRD) at baseline who received blinatumomab treatment achieved MRD-negative remission. On the contrary, only 24% of patients with MRD at baseline treated with chemotherapy achieved MRD negativity.
The overall survival (OS) estimate measured at 36 months was 81.1% for patients treated with blinatumomab compared to 55.8% for patients treated with chemotherapy.
The safety profile featured grade 3 or higher adverse events (AEs) for 57.4% of patients in the blinatumomab group versus 82.4% of patients in the chemotherapy group. Serious AEs occurred in 24.1% and 43.1% of patients in the blinatumomab and chemotherapy groups, respectively.
Common AEs included pyrexia (81.5% of patients), nausea (40.7%), headache (35.2%), stomatitis (35.2%), and vomiting (29.6%) for patients in the blinatumomab group.
"I am thrilled the study results demonstrated that Blincyto was more effective and associated with fewer and less severe toxicities compared to intensive chemotherapy," study investigator Franco Locatelli, MD, PhD, of the Department of Pediatric Hematology and Oncology, Bambino Gesù Children's Hospital, Rome, said in a press release.
The primary end point of the research was EFSs, with secondary end points including OS and MRD response, safety, 100-day mortality after allogeneic hematopoietic stem cell transplantation, incidence of anti-blinatumomab antibody formation, and cumulative incidence of relapse.
Blinatumomab is a “bispecific CD19-directed CD3 T cell BiTE® (bispecific T cell engager) molecule,” and is the first and only therapeutic to receive approval to treat patients with MRD-positive B-cell precursor ALL.
"Chemotherapy has been used as primary consolidation treatment for ALL patients before receiving a stem cell transplant, despite this approach being only partially effective and associated with relevant toxicity,” Locatelli said. “Blincyto has now been shown to be a more effective and safer consolidation therapy option for children with high-risk first-relapse B-ALL."
BLINCYTO® (Blinatumomab) Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation Chemotherapy In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia. News release. Amgen. Published March 2, 2021. Accessed March 3, 2021. https://www.prnewswire.com/news-releases/blincyto-blinatumomab-demonstrated-significantly-prolonged-event-free-survival-compared-with-consolidation-chemotherapy-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-301238918.html