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| Therapy Name | Eftilagimod alpha + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Eftilagimod alpha | IMP321|LAG-31g|Immufact | Eftilagimod alpha (IMP321) is a recombinant soluble LAG3 protein, which binds to MHC Class II molecules, resulting in increased dendritic cell maturation and potentially leading to enhanced anti-tumor immune response (PMID: 16621192, PMID: 17785860, PMID: 20653948, PMID: 30977393). | ||
| 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). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 over exp | head and neck squamous cell carcinoma | predicted - sensitive | Eftilagimod alpha + Pembrolizumab | Phase II | Actionable | In a Phase II trial, Eftilagimod alpha (IMP321) and Keytruda (pembrolizumab) combination therapy resulted in an objective response rate (ORR) of 29.7% (11/37) and disease control rate (DCR) of 37.8% in patients with recurrent or metastatic head and neck squamous cell carcinoma, with an ORR of 60% (9/15), median progression-free survival of 13.6 months, and a median overall survival of 15.5 months in patients with high CD274 expression (PD-L1; CPS>/=20) (PMID: 38995265; NCT03625323). | 38995265 |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06128863 | Phase II | Eftilagimod alpha + Pembrolizumab | Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial (EFTISARC-NEO) | Active, not recruiting | POL | 0 |
| NCT03625323 | Phase II | Eftilagimod alpha + Pembrolizumab | Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC (TACTI-002) | Completed | USA | 0 |
| NCT04811027 | Phase II | Eftilagimod alpha + Pembrolizumab Pembrolizumab | Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC (TACTI-003) | Completed | USA | ROU | GBR | ESP | DNK | DEU | BEL | AUS | 1 |