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| Therapy Name | Ficerafusp Alfa + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ficerafusp Alfa | BCA-101|BCA 101|BCA101 | EGFR Antibody 74 TGFB (Pan) Antibody 5 | Ficerafusp alfa (BCA101) is a bifunctional antibody that targets both EGFR and TGFB and leads to inhibition of downstream signaling, which may lead to inhibition of tumor cell proliferation and activation of anti-tumor immune response (PMID: 37074042). | |
| 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 |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04429542 | Phase I | Ficerafusp Alfa Ficerafusp Alfa + Pembrolizumab | Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors | Recruiting | USA | CAN | AUS | 0 |
| NCT06788990 | Phase II | Pembrolizumab Ficerafusp Alfa + Pembrolizumab | FORTIFI-HN01: a Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC (FORTIFI-HN01) | Recruiting | USA | POL | NZL | ITA | IRL | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 1 |