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A peer-reviewed article of this preprint also exists.
This version is not peer-reviewed
Submitted:
05 December 2023
Posted:
06 December 2023
You are already at the latest version
Drug | Trial | Phase | Study population, number (n) | ORR (%) | mDOR months | mOS months | mPFS months | FDA approval | Adverse effects |
---|---|---|---|---|---|---|---|---|---|
Pemigatinib FGFR 1-3 inhibitor |
Abou-Alfa et al. FIGHT-202 trial [76,77] |
II |
Locally advanced, unresectable or metastatic CCA with FGFR2 gene fusion or rearrangements, progressed on at least one prior line of therapy. n = 146 |
35.5 | 9.1m | 17.5 |
- | April 17, 2020 as second line | Hyperphosphatemia, alopecia, dysgeusia, diarrhea, fatigue, stomatitis, dry mouth, arthralgia, hyponatremia, abdominal pain, fatigue, pyrexia, cholangitis, and pleural effusion |
Gotlib et al. FIGHT-203 trial [80] |
II | MLNs with FGFR1 rearrangement regardless of prior lines of treatment. n = 34 | 64.7 (CR) |
Not reached | - | - | August 26, 2022 as second line | Hyperphosphatemia, alopecia, diarrhea, stomatitis, anemia, and pain in extremity | |
Infigratinib FGFR 1-3 inhibitor |
Javle et al. CBGJ398X2204 trial [84] |
II | Locally advanced, or metastatic CCA with FGFR2 fusions or rearrangements, progressed on at least one prior line. n = 108 | 23.1 | 5 | - | 7.3 | May 28, 2021 as second line | Hyperphosphatemia, eye disorders, hyponatremia, stomatitis, and fatigue |
Erdafitinib FGFR 1-4 inhibitors |
Siefker-Radtke et al. BLC2001 trial [88] |
II | Locally advanced, unresectable, or metastatic urothelial cancers with FGFR alterations, progressed on at least prior line or within 12 months after neoadjuvant or adjuvant chemotherapy. n = 99 | 40 | 5.6 | 13.8 | 5.5 | April 12, 2019 as second line | Hyperphosphatemia, stomatitis, diarrhea, and dry mouth, hyponatremia, and asthenia |
Futibatinib FGFR 1-4 inhibitor |
Goyal et al. FOENIX-CCA2 trial [93] |
II | Locally advanced, unresectable, or metastatic iCCA with FGFR2 fusions or rearrangements who progressed on at least one prior line. n=109 | 42 | 9.7 | 21.7 | 9.0 | September 30, 2022 as second line | Hyperphosphatemia, alopecia, dry mouth, diarrhea, dry skin, fatigue, increased aspartate aminotransferase level, and stomatitis |
Multi-TKIs | Targets |
---|---|
Dovitinib (TKI258) | FGFR, VEGFR, PDGFR inhibitor [111] |
Lenvatinib (E7080) | VEGFR 1-3, FGFR 1-4, PDGFR α, RET, KIT [112] |
Lucatinib (E-3810) | FGFR1-2, VEGFR1-3, and PDGFRα-β [113] |
Pazopanib (GW786034) | FGFR 1-2, VEGFR 1-3, PDGFRα-β, C-kit (stem cell factor receptor) [114] |
Ponatinib (AP24534) | FGFR 1-4, VEGFR2, PDGFRα, c-SRC, c-Kit, FLT3, RET [115] |
Agent | NCT | Status | Conditions | Phase |
---|---|---|---|---|
Pemigatinib | NCT03914794 | R | Non-muscle invasive bladder cancer (NMIBC) with recurrent low or intermediate risk tumors (as neoadjuvant) | II |
Pemigatinib | NCT03011372 | A, NR | Previously treated myeloid/lymphoid neoplasms with FGFR1 rearrangement (FIGHT-203) | II |
Pemigatinib vs Gemcitabine +cisplatin |
NCT03656536 | R | Untreated unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement (FIGHT-302) | III |
Pemigatinib | NCT05565794 | R | Intrahepatic cholangiocarcinoma with FGFR2 gene mutation, rearrangement, or translocation after curative local therapy | II |
Pemigatinib | NCT05267106 |
R | Previously treated glioblastoma or other primary central nervous system tumors harboring activating FGFR1-3 alterations (FIGHT-209) | II |
Pemigatinib | NCT05253807 | A, NR | Relapsed or refractory advanced non-small cell lung cancer with an FGFR alteration (FIGHT-210) | II |
Pemigatinib | NCT04659616 | R | Acute myeloid leukemia after initial induction chemotherapy with adverse or intermediate risk cytogenetics | I |
Futibatinib | NCT04189445 | A, NR | Previously treated advanced or metastatic solid tumors, gastric or gastroesophageal cancers, myeloid or lymphoid neoplasms with FGFR 1-4 rearrangements | II |
Futibatinib +/- fulvestrant |
NCT04024436 | A, NR | Previously treated metastatic breast cancer with FGFR1 and FGFR2 amplification | II |
Futibatinib vs gemcitabine + cisplatin |
NCT04093362 | A, NR | Previously untreated advanced cholangiocarcinoma harboring FGFR2 gene rearrangements (FOENIX-CCA3) | III |
Futibatinib | NCT05727176 | R | Previously treated advanced cholangiocarcinoma with FGFR2 fusion or rearrangement (FOENIX-CCA4) | II |
Futibatinib + pembrolizumab |
NCT04828486 | R | Advanced or metastatic hepatocellular carcinoma with FGF19 expression | II |
Futibatinib + pembrolizumab |
NCT04601857 | R | Advanced or metastatic urothelial carcinoma who are not candidates to receive a platinum-based treatment regimen | II |
Futibatinib + pembrolizumab |
NCT05036681 | R | Previously treated locally advanced or metastatic microsatellite stable endometrial carcinoma | II |
Infigratinib | NCT04233567 | A, NR | Previously treated advanced or metastatic solid tumors, cholangiocarcinoma and refractory malignant solid neoplasm with FGFR gene mutations | II |
Infigratinib | NCT04228042 | A, NR | Renal pelvis and upper tract urothelial cancer as neoadjuvant treatment | I/II |
Erdafitinib | NCT04917809 | R | Recurrent non-Invasive Bladder Cancer with FGFR3 gene mutation after treatment with instillations of BCG or chemotherapy into the bladder | II |
Erdafitinib | NCT04083976 |
A, NR | Advanced or metastatic solid tumors with FGFR alterations (mutations or gene fusions) after at least one prior line of systemic therapy (RAGNAR) | II |
Erdafitinib | NCT04754425 | R | Castration-resistant prostate cancer after progressed on second generation androgen receptor targeting agents | II |
Erdafitinib + fulvestrant + palbociclib | NCT03238196 | A, NR | Previously treated HR positive HER2 negative FGFR amplified metastatic breast cancer | I |
Fisogatinib | NCT02508467 | A, NR | Hepatocellular carcinoma with FGF19 expression with or without prior tyrosine kinase inhibitors | I |
Derazantinib + atezolizumab |
NCT05174650 | R | Previously treated advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements | II |
Lirafugratinib (RLY4008) |
NCT04526106 |
R | Previously treated unresectable/metastatic intrahepatic cholangiocarcinoma and other advanced tumors with FGFR2 alterations (REFOCUS) | I/II |
Dovitinib + PARP inhibitor Stenoparib (2X-121) |
NCT05571969 |
R | Advanced Solid Tumors | I |
Rogaratinib (BAY1163877) + atezolizumab |
NCT03473756 | A, NR | Metastatic or locally advanced cisplatin ineligible patients with urothelial carcinoma and FGFR 1 or 3 alterations (FORT-2) | Ib/II |
Rogaratinib | NCT04595747 | A, NR | Previously treated advanced or metastatic sarcoma with FGFR 1-4 alterations and in patients with SDH-deficient Gastrointestinal Stromal Tumor (GIST) | II |
Fexagratinib AZD4547 + tislelizumab |
NCT05775874 | R | Locally advanced or metastatic urothelial cancer with FGFR2/3 alterations in Chinese patient population | II |
Bemarituzumab |
NCT05325866 | R | Refractory or relapsed advanced or metastatic solid tumors with FGFR2b overexpression after at least one prior line (FORTITUDE-301) | I |
Bemarituzumab+ mFOLFOX6+ nivolumab vs mFOLFOX6+ nivolumab |
NCT05111626 | R | Untreated advanced or metastatic gastric and gastroesophageal junction (GEJ) cancer with FGFR2b overexpression (FORTITUDE-102) | III |
Bemarituzumab+ + mFOLFOX vs mFOLFOX |
NCT05052801 | R | Previously treated advanced or metastatic Gastric or GEJ Cancers with FGFR2b overexpression (FORTITUDE-101) | III |
Bemarituzumab +anti-cancer therapy |
NCT05267470 | A, NR | Advanced or metastatic squamous lung cancer with FGFR2b overexpression (FORTITUDE-201) | I |
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