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| Therapy Name | Cisplatin + Fluorouracil + Sugemalimab |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| 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). |
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov). |
| Sugemalimab | Cejemly | WBP3155|CS1001 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | Sugemalimab (CS1001) is a monoclonal antibody against CD274 (PD-L1) that inhibits binding to the PDCD1 (PD1) receptor, potentially resulting in enhanced anti-tumor immune response (PMID: 28679395). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 positive | esophagus squamous cell carcinoma | predicted - sensitive | Cisplatin + Fluorouracil + Sugemalimab | Phase III | Actionable | In a Phase III trial (GEMSTONE-304), treatment with Sugemalimab (CS1001) combined with chemotherapy (Platinol (cisplatin) and Adrucil (fluorouracil)) demonstrated safety in patients with esophagus squamous cell carcinoma (n=358), and in CD274 (PD-L1)-positive patients (IHC >=10%, n=154), resulted in improved median progression-free survival (7.0 vs 5.4 mo, HR=0.50) and median overall survival (15.7 vs 11.2 mo, HR=0.57) compared to the placebo plus chemotherapy cohort (n=78) (PMID: 38302715; NCT04187352). | 38302715 |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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