Therapy Detail
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| Therapy Name | Atezolizumab + Rogaratinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Atezolizumab | Tecentriq | RG7446|MPDL3280A | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Tecentriq (atezolizumab) is a monoclonal antibody against PD-L1 (CD274), preventing activation of its receptor, potentially enhancing T-cell-mediated immune response to neoplasms and inhibiting T-cell inactivation (PMID: 29449897). Tecentriq (atezolizumab) is FDA approved for use in PD-L1 positive (IC >/= 5%) advanced or metastatic urothelial carcinoma not eligible for cisplatin-containing chemotherapy, in advanced or metastatic urothelial carcinoma not eligible for chemotherapy, in metastatic non-small cell lung cancer (NSCLC) progressed on platinum-containing therapy, as first-line therapy in metastatic NSCLC with high PD-L1 expression (TC>/=50% or IC>/=10%) and without EGFR or ALK alterations, for adjuvant treatment in patients with PD-L1-positive (>=1% tumor cell expression) NSCLC, in combination with bevacizumab, paclitaxel, and carboplatin as first-line therapy for non-squamous NSCLC with no EGFR or ALK aberrations, in combination with paclitaxel protein-bound and carboplatin in metastatic non-squamous NSCLC with no EGFR or ALK aberrations, in combination with carboplatin and etoposide in extensive-stage small cell lung cancer, in combination with bevacizumab in hepatocellular carcinoma without prior systemic therapy, in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) in unresectable or metastatic BRAF V600-mutated melanoma, and in pediatric and adult patients with unresectable or metastatic alveolar soft part sarcoma (FDA.gov). |
| Rogaratinib | BAY 1163877|BAY-1163877|BAY1163877 | FGFR Inhibitor (Pan) 26 | Rogaratinib (BAY 1163877) is a small molecule pan-FGFR inhibitor, which reduces downstream signaling, potentially resulting in decreased tumor cell proliferation (PMID: 27429073, PMID: 29451369, PMID: 30807645, PMID: 31405822). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR3 over exp | transitional cell carcinoma | sensitive | Atezolizumab + Rogaratinib | Phase I | Actionable | In a Phase Ib trial (FORT-2), Tecentriq (atezolizumab) and Rogaratinib (BAY 1163877) combined therapy demonstrated safety and led to an objective response rate (ORR) of 43% (16/37, 5 complete and 11 partial responses), disease control rate of 65% (24/37), median progression-free survival of 6.1 mo, median overall survival of 12.0 mo, and ORR of 54% (14/26) at the RP2D of 600mg in cisplatin-ineligible patients with metastatic urothelial cancer with FGFR1 or FGFR3 overexpression (PMID: 39298147; NCT03473756). | 39298147 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03473756 | Phase Ib/II | Atezolizumab Atezolizumab + Rogaratinib | Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (FORT-2) | Completed | USA | ITA | FRA | ESP | DEU | AUT | 2 |
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