This completes enrollment for the study.
The trial evaluates the combination of eftilagimod alpha ('efti' or 'IMP321'), an antigen presenting cell activator, with a standard dose of avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies. Avelumab is co-developed and co-commercialized by
Prof.
The first cohort of six patients in the INSIGHT-004 study received a standard dose of avelumab and a 6 mg dose of efti with no new safety signals or dose limiting toxicities. The observed safety profile also aligns with the known safety profile of the monotherapies. Participants enrolled in the INSIGHT-004 trial are patients with late-stage cancer who have been heavily pre-treated for advanced, metastatic solid tumors. Typically, they have no other therapy options available.
INSIGHT-004 is the fourth arm of the INSIGHT trial which is being conducted by
About INSIGHT-004
INSIGHT-004 is being conducted as an amendment to the ongoing INSIGHT Phase I clinical trial.
Avelumab Approved Indications
Avelumab (BAVENCIO) in combination with axitinib is indicated in the US, EU,
The
Avelumab is currently approved for patients with mMCC in more than 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.
Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.
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Email: cstrong@citadelmagnus.com
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