In June, 2024, the U.S. Food and Drug Administration (FDA) has expanded approval of Blincyto (blinatumomab) in to include the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. The expanded approval is the third indication for Blincyto and is based on efficacy and safety data from the E1910 clinical trial in adults as well as Study 20120215 in pediatric and young adult patients.
Trial Results
- Adults: After 5 years, 82% of patients receiving Blincyto were still alive, compared to 63% with chemotherapy alone.
- Children and young adults: After 5 years, 78% of patients receiving blinatumomab were alive, compared to 41% with chemotherapy alone.
- In the E1910 study, the most common side effects during consolidation cycles in the Blincyto arm were neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain, and tremor.
About Blincyto
Blincyto is a BiTE® antibody construct designed to direct the body’s cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. Blincyto is the first of the BiTE® antibody construct approved by the US Food and Drug Administration and its incorporation into the management of ALL is improving patient outcomes.
About BiTE® Technology Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
Indications: Blincyto is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients one month and older with:
- Philadelphia chromosome-negative disease in the consolidation phase of multiphase chemotherapy.
- Minimal residual disease (MRD) greater than or equal to 0.1% in first or second complete remission.
- Relapsed or refractory disease.
Safety: The prescribing information for Blincyto includes a Boxed Warning warning for serious or life-threatening cytokine release syndrome and neurological toxicities including immune effector cell-associated neurotoxicity syndrome. The most common side effects are pyrexia, influsion-related reactions, headache, infection, musculoskeletal pain, neutropenia, nausea, anemai, thrombocytopenia, and diarrhea. Patients should discuss the risks and benefits of treatment with their oncologists.
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References:
2. Litzow MR, Sun Z, Mattison RJ, et al. Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults. N Engl J Med. 2024 Jul 25;391(4):320-333.
3. Locatelli F, Eckert C, Hrusak O, et al. Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Aug;69(8):e29715.
