On August 17, 2021 Partner Therapeutics, Inc. (PTx) reported that Frontiers in Immunology published a systematic review of LEUKINE titled, "Sargramostim (rhu GM-CSF) as Cancer Therapy (Systematic Review) and An Immunomodulator (Press release, Partner Therapeutics, AUG 17, 2021, View Source [SID1234586701]). A Drug Before Its Time?" This manuscript chronicles Leukine’s 30-year history in oncology research, including 27 studies that each enrolled 50 or more patients. Importantly, this clinical research spans multiple therapeutic areas, providing insight into how endogenous GM-CSF orchestrates innate and adaptive immune responses.
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Lead author Hillard Lazarus, MD, FACP, Professor of Medicine at Case Western Reserve University and advisor to Partner Therapeutics, stated, "We can no longer view GM-CSF as a hematopoietic growth factor alone. These data suggest an emerging role for sargramostim immune suppressed sepsis, refractory bacterial and fungal infections, viral respiratory infections, autoimmune pulmonary alveolar proteinosis (aPAP), neurodegenerative diseases, and in combination with immune checkpoint inhibitors." GM-CSF has wide-ranging effects on diverse myeloid cells, including monocytes, macrophages and dendritic cells. It stimulates innate immune responses by activating macrophages and dendritic cells that prompt development of antigen-specific T cells and regulatory T cells, thereby linking innate and adaptive immune systems.
"This review article highlights Leukine’s potential to generate benefit for patients in numerous diseases that feature GM-CSF deficiency," said Edwin Rock, MD, PhD, Partner Therapeutics Chief Medical Officer. "We are committed to engaging in partnerships and supporting research that illuminates how Leukine works in these varied settings and demonstrates Leukine’s potential in both oncologic and non-oncologic diseases."
ABOUT LEUKINE
LEUKINE (sargramostim) is a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) Leukine is approved by the U.S. Food and Drug Administration (FDA) and is also held by the U.S. government in the Strategic National Stockpile. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data should not be extrapolated.
Leukine is indicated:
To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients.
For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients two years of age and older.
For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older.
For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients two years of age and older.
To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Important Safety Information for Leukine (sargramostim)
Contraindications
LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.
Warnings and Precautions
Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If absolute neutrophil count (ANC) is greater than 20,000 cells/mm3 or if white blood cell (WBC) counts are greater than 50,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
LEUKINE therapy should be discontinued if disease progression is detected during treatment.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9 percent benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.
Adverse Reactions
Adverse events occurring in greater than 10 percent of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:
In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
In Allogeneic BMT patients–abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, gastro intestinal (GI) hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema