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Therapy Name Cemiplimab + Cisplatin + Fianlimab + Gemcitabine
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cemiplimab Libtayo REGN2810|SAR439684 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 120 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, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov).
Cisplatin Platinol CDDP Chemotherapy - Platinum 7 Platinol (cisplatin) is a platinum based chemotherapeutic, which is FDA approved for bladder, ovarian, and testicular cancers (NCI Drug Dictionary).
Fianlimab REGN 3767|R3767|REGN3767 Immune Checkpoint Inhibitor 149 LAG3 Antibody 18 Fianlimab (REGN3767 ) is a monoclonal antibody that targets LAG3, potentially resulting in increased anti-tumor immune response (PMID: 31395688).
Gemcitabine Gemzar Difluorodeoxycytidine Hydrochlorothiazide|LY-188011 Chemotherapy - Antimetabolite 14 Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06571708 Phase II Cemiplimab + Cisplatin + Gemcitabine Cemiplimab + Cisplatin + Fianlimab + Gemcitabine A Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) (NeoSTOP-IT) Not yet recruiting USA 0


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