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Therapy Name Pembrolizumab + VIR-5818
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov).
VIR-5818 AMX 818|AMX818|VIR5818|VIR 5818|AMX-818 CD3 Antibody 121 HER2 (ERBB2) Antibody 80 VIR-5818 is a prodrug T-cell engager that targets CD3 and ERBB2 (HER2) which is activated in the tumor microenvironment, potentially resulting in activation of an immune response against ERBB2 (HER2)-expressing tumors and inhibition of tumor growth (Mol Cancer Ther 2021;20(12 Suppl):Abstract nr P193).

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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
NCT05356741 Phase Ib/II Pembrolizumab + VIR-5818 VIR-5818 To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Recruiting FRA | ESP | AUS 1


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