Horizon Pharma plc and Fox Chase Cancer Center Temple Health Initiate Phase 1 Study to Evaluate ACTIMMUNE(R) (interferon gamma-1b) in Combination With Nivolumab in Patients With Advanced Solid Tumors
Horizon Pharma plc and Fox Chase Cancer Center Temple Health Initiate Phase 1 Study to Evaluate ACTIMMUNE(R) (interferon gamma-1b) in Combination With Nivolumab in Patients With Advanced Solid Tumors
"We are eager to explore the safety and efficacy of ACTIMMUNE in combination with nivolumab in multiple, difficult-to-treat cancers that are often inoperable or have become unresponsive to standard therapies," said
The Phase 1, open label study will evaluate the combination of ACTIMMUNE and nivolumab in patients with advanced solid tumors who have progressed on at least one prior systemic therapy, which may include prior immunotherapy. Patients will be treated with a one week induction phase of ACTIMMUNE (starting dose 50 mcg/m2 subcutaneously), followed by a combination phase with ACTIMMUNE and nivolumab (3 mg/kg intravenously) for three cycles, followed by a single-agent phase of nivolumab alone for up to one year.
"Nivolumab and other PD-1 inhibitors have demonstrated clinical benefit in multiple trials across many advanced solid tumor types," said
The study will primarily assess the safety and tolerability of the combination of ACTIMMUNE and nivolumab. Secondary objectives, including overall response rate, progression free survival and overall survival, will also be assessed, as will various correlative analyses. Initial accrual will occur using a modified 6+6 design, and if endpoints for safety (using dose-limiting toxicity criteria) are met, expansion cohorts in renal cell carcinoma (kidney cancer) and urothelial carcinoma (bladder cancer) are planned for up to 15 patients per cohort.
Additional detail about the study can be found at ClinicalTrials.gov.
About ACTIMMUNE®
ACTIMMUNE (interferon gamma-1b) is a biologically manufactured protein similar to one the body makes naturally to help prevent infection. ACTIMMUNE is currently approved by the
Indications and Usage
Chronic Granulomatous Disease (CGD)
ACTIMMUNE is approved by the
Severe, Malignant Osteopetrosis (SMO)
ACTIMMUNE is approved by the
Important Safety Information (ISI)
The most common side effects with ACTIMMUNE are "flu like" symptoms, such as fever, headache, chills, myalgia (muscle pain), or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may minimize these symptoms. Acetaminophen may be helpful in preventing fever and headache.
ACTIMMUNE can cause severe allergic reactions and/or rash. Do not use ACTIMMUNE if you are allergic to interferon-gamma, E. col-derived products, or any component of the product. (See Full Prescribing Information for a list of components). If you develop a serious reaction to ACTIMMUNE discontinue it immediately and contact your doctor or seek medical help.
At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions. Tell your doctor if you have a cardiac condition, such as irregular heartbeat, heart failure, or decreased blood flow to your heart.
ACTIMMUNE may cause reversible changes to your nervous system, including decreased mental status, walking disturbances, and dizziness. Tell your doctor if you have a history of seizures or other neurological disorders.
Bone marrow function may be suppressed with ACTIMMUNE and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced. Tell your doctor if you have, or have had reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3 month intervals thereafter.
Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than one year old. Your doctor will monitor your liver function at the beginning of therapy and at 3 month intervals thereafter.
If you are pregnant or plan to become pregnant or plan to nurse you should consult your physician.
If you are receiving ACTIMMUNE at home, your doctor will provide to you or your caregiver appropriate instructions on the administration of the drug and disposal of the container, needles and syringes.
You are encouraged to report negative side effects of prescription drugs to the
This information is not intended to replace discussions with your doctor. For additional information about ACTIMMUNE, please consult the Full Prescribing Information and the Information for the Patient/Caregiver and talk to your doctor. ACTIMMUNE is available by prescription only.
Visit www.ACTIMMUNE.com to download a copy of the ACTIMMUNE Full Prescribing Information.
About
About
Forward Looking Statements
This press release contains forward-looking statements, including statements regarding the scope and design of the Phase 1 clinical evaluating ACTIMMUNE in solid tumors, potential initiation of expansion cohorts evaluating ACTIMMUNE in urothelial carcinoma (bladder cancer) and renal cell carcinoma, and the potential benefits of ACTIMMUNE in combination with PD-1 inhibitors. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding
whether Horizon will be able to continue its collaboration with
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Investor-relations@horizonpharma.com
Vice President, Investor Relations
investor-relations@horizonpharma.com
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gcurtis@horizonpharma.com
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