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|Therapy Name||Cemiplimab + SAR439459|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cemiplimab||Libtayo||REGN2810|SAR439684||Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 79||Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, and as first-line treatment in patients with advanced non-small cell lung cancer with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations (FDA.gov).|
|SAR439459||SAR-439459|SAR 439459||TGFB (Pan) Antibody 4||SAR439459 is a monoclonal antibody that targets transforming growth factor beta 1 (TGFB1, TGFbeta), which may lead to tumor regression in combination with PD-1 (PDCD1) immune checkpoint inhibitors (AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2790).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03192345||Phase I||Cemiplimab + SAR439459 SAR439459||A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and REGN2810 in Patients With Advanced Solid Tumors||Active, not recruiting||USA | CAN||11|
|NCT04729725||Phase I||Cemiplimab + SAR439459||Strategic Alliance: Phase 1b Trial Assessing Combination of TGF-beta Inhibitor and PD-1 Inhibitor Cemiplimab||Recruiting||USA||0|