Therapy Detail
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| Therapy Name | Atezolizumab + Derazantinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Atezolizumab | Tecentriq | RG7446|MPDL3280A | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | 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 cisplatin ineligible urothelial carcinoma, 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 PD-L1-high (TC>/=50% or IC>/=10%) NSCL 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 (ES-SCLC), 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, in combination with lurbinectedin for ES-SCLC, and in pediatric and adult patients with unresectable or metastatic alveolar soft part sarcoma (FDA.gov). |
| Derazantinib | ARQ 087 | FGFR1 Inhibitor 28 FGFR2 Inhibitor 24 KIT Inhibitor 57 LCK Inhibitor 6 | Derazantinib (ARQ 087) is an ATP-competitive multi-kinase inhibitor with activity against Fgfr 1/2, FGFR fusions, Arg, Lck, and Kit, which prevents cell proliferation and angiogenesis (PMID: 27627808). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FGFR3 act mut | transitional cell carcinoma | no benefit | Atezolizumab + Derazantinib | Phase Ib/II | Actionable | In a Phase I/II trial (FIDES-02), combination treatment with Derazantinib (ARQ 087) and Tecentriq (atezolizumab) was well tolerated but demonstrated limited efficacy in patients with urothelial carcinoma harboring FGFR3 mutations (n=8) or FGFR3 fusions (n=2), with an objective response rate (ORR) of 0% (0/10) and disease control rate of 20.0% (2/10) by independent central review (PMID: 38627238; NCT04045613). | 38627238 |
| FGFR3 fusion | transitional cell carcinoma | no benefit | Atezolizumab + Derazantinib | Phase Ib/II | Actionable | In a Phase I/II trial (FIDES-02), combination treatment with Derazantinib (ARQ 087) and Tecentriq (atezolizumab) was well tolerated but demonstrated limited efficacy in patients with urothelial carcinoma harboring FGFR3 mutations (n=8) or FGFR3 fusions (n=2), with an objective response rate (ORR) of 0% (0/10) and disease control rate of 20.0% (2/10) by independent central review (PMID: 38627238; NCT04045613). | 38627238 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05174650 | Phase II | Atezolizumab + Derazantinib | Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements | Active, not recruiting | DEU | 0 |
| NCT04045613 | Phase Ib/II | Derazantinib Atezolizumab + Derazantinib | Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) | Completed | USA | POL | ITA | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUT | AUS | 1 |
| NCT04604132 | Phase Ib/II | Atezolizumab + Derazantinib Derazantinib + Paclitaxel + Ramucirumab Derazantinib Paclitaxel + Ramucirumab | Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (FIDES-03) | Terminated | USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | BRA | BEL | AUS | ARG | 3 |
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