Saturday, July 13, 2024

Leukemia Treatment Advances with FDA Approval of Blincyto by Amgen for B-ALL

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Leukemia treatment has advanced with the Food and Drug Administration’s (FDA) approval of Amgen’s Blincyto (blinatumomab) for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase for patients over one month of age. According to Amgen, the patient’s measurable residual disease (MRD) status will not affect treatment eligibility with Blincyto. This approval is based on the Phase III E1910 clinical trial results, which demonstrated a significant improvement in overall survival (OS) when Blincyto was used in combination with multiphase consolidation chemotherapy.

Jay Bradner, MD, Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, emphasized the importance of this approval in a press release. He stated, “B-ALL is an aggressive blood cancer with an enduring high unmet need. Blincyto has helped thousands of patients with B-ALL over the last 10 years. Today’s approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE) therapy.”

The E1910 trial was a randomized clinical study that evaluated the efficacy of Blincyto in combination with chemotherapy compared to chemotherapy alone in treating B-ALL. The trial enrolled 488 patients to assess whether the addition of Blincyto could deepen remission and achieve durable responses. Following remission induction, patients who achieved morphologic complete remission continued in the study.

Blincyto Significantly Improves Survival Rates in Leukemia Patients

These patients were then randomly assigned to receive either an additional four cycles of consolidation chemotherapy or two cycles of Blincyto for 28 days each cycle, followed by three cycles of consolidation chemotherapy, another four-week cycle of Blincyto, a subsequent cycle of chemotherapy, and a final fourth cycle of Blincyto. The primary endpoint was to compare the overall survival (OS) in MRD-negative patients receiving Blincyto with those receiving chemotherapy alone.

The results were compelling. The three-year OS rate in the Blincyto and chemotherapy combination arm was 84.8%, compared to 69% in the chemotherapy-only arm. Additionally, the five-year OS rate was 82.4% for the combination arm, compared to 62.5% for the chemotherapy arm, with a median follow-up of 4.5 years. These results highlight the substantial survival benefit of incorporating Blincyto into the treatment regimen for B-ALL. In terms of safety, common adverse events associated with Blincyto included pyrexia, infusion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemia, thrombocytopenia, and diarrhea. These adverse events were consistent with those observed in previous studies of Blincyto.

Selina M. Luger, MD, a professor of hematology-oncology at the University of Pennsylvania’s Perelman School of Medicine and Abramson Cancer Center, and chair of the ECOG-ACRIN Leukemia Committee, was an investigator in the E1910 study. She commented on the significant findings, stating, “In the E1910 study, blinatumomab reduced the risk of death and showed a remarkable improvement in overall survival. This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.”

Leukemia

FDA Approval of Blincyto Brings New Hope in the Fight Against Acute Lymphoblastic Leukemia

The impact of acute lymphoblastic leukemia (ALL) is profound. Between 2014 and 2020, it was estimated that 72% of patients diagnosed with ALL survived five years or more. In 2021, around 115,294 people were living with ALL in the United States. The disease is most prevalent among children, adolescents, and young adults aged 15-39 years. It is expected that 0.1% of the population will develop ALL in their lifetime, with an estimated 1,330 people expected to die from it in 2024.

E. Anders Kolb, MD, President and CEO of The Leukemia & Lymphoma Society, highlighted the significance of this approval, noting, “The risk of B-ALL recurrence after the initial phase of treatment is relatively high, making this approval for patients noteworthy. B-ALL is the most common type of ALL, and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give these patients more time with their loved ones.”

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This FDA approval of Blincyto marks a significant advancement in the treatment of B-ALL. It offers a new hope for patients and sets a new standard of care that could potentially improve survival outcomes and quality of life for many individuals affected by this aggressive blood cancer. As the medical community continues to innovate and develop new therapies, approvals like this one provide crucial steps forward in the ongoing battle against leukemia.

 

Resource: Amgen, June 17, 2024

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