Therapy Detail

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Therapy Name Nivolumab + Pegilodecakin
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 66 Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic non-small cell lung cancer without EGFR or ALK alterations, and in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations (FDA.gov).
Pegilodecakin AM0010|AM-0010 Pegilodecakin (AM0010) is recombinant human interleukin-10 (IL-10) conjugated with polyethylene glycol (PEG), which may induce anti-tumor immune response (J Clin Oncol 34, 2016 (suppl; abstr 3082), PMID: 31706853, PMID: 31563517).

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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown renal cell carcinoma not applicable Nivolumab + Pegilodecakin Phase I Actionable In a Phase Ib trial (IVY), Pegilodecakin (AM0010) and Keytruda (pembrolizumab) (n=9) or Opdivo (nivolumab) (n=29) combination therapy demonstrated safety and preliminary efficacy, resulting in an objective response rate of 40% (14/35, 14 partial responses) and a disease control rate of 86% (30/35) in evaluable patients with renal cell carcinoma, with a median duration of response of 15.1 months (PMID: 31563517; NCT02009449). 31563517
Unknown unknown lung non-small cell carcinoma not applicable Nivolumab + Pegilodecakin Phase I Actionable In a Phase Ib trial (IVY), Pegilodecakin (AM0010) and Keytruda (pembrolizumab) (n=5) or Opdivo (nivolumab) (n=29) combination therapy demonstrated safety and preliminary efficacy, resulting in an objective response rate of 43% (12/28, 1 complete response, 11 partial responses) and a disease control rate of 82% (23/28) in evaluable patients with non-small cell lung carcinoma, with a median duration of response of 10.3 months (PMID: 31563517; NCT02009449). 31563517

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03382912 Phase II Nivolumab + Pegilodecakin Nivolumab Study of AM0010 With NivolumabStudy of AM0010 With Nivolumab Compared to Nivolumab Alone Second-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 2) Terminated


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