^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners
BIOMARKER:

FGFR mutation

i
Other names: FGFR, Fibroblast Growth Factor Receptor
2d
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer (clinicaltrials.gov)
P1, N=112, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jun 2027 --> Mar 2028 | Trial primary completion date: Apr 2025 --> Mar 2028
Trial completion date • Trial primary completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
erdafitinib intravesical delivery system (TAR-210)
24d
The irreversible FGFR inhibitor KIN-3248 overcomes FGFR2 kinase domain mutations. (PubMed, Clin Cancer Res)
Thus, KIN-3248 is a novel FGFR1-4 inhibitor whose distinct activity profile against FGFR kinase domain mutations highlights its potential for the treatment of ICC and other FGFR-driven cancers.
Journal
|
FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3)
|
FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR3 fusion • FGFR3 V555M
|
KIN-3248
26d
Trial completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
gemcitabine • Balversa (erdafitinib) • mitomycin
28d
FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions. (PubMed, Nat Rev Clin Oncol)
Various agents, including pan-FGFR inhibitors (erdafitinib and futibatinib), FGFR1/2/3 inhibitors (infigratinib and pemigatinib), as well as a range of more-specific agents, have been developed and several have entered clinical use. The next generation of small-molecule inhibitors, such as lirafugratinib and LOXO-435, and the FGFR2-specific antibody bemarituzumab are expected to have a reduced risk of hyperphosphataemia and the ability to overcome certain resistance mutations. In this Review, we describe the development and current clinical role of FGFR inhibitors and provide perspective on future research directions including expansion of the therapeutic indications for use of FGFR inhibitors, combination of these agents with immune-checkpoint inhibitors and the application of novel technologies, such as artificial intelligence.
Review • Journal
|
TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor)
|
TP53 mutation • FGFR2 fusion • FGFR mutation • FGFR1 fusion
|
Balversa (erdafitinib) • Truseltiq (infigratinib) • Lytgobi (futibatinib) • Pemazyre (pemigatinib) • bemarituzumab (AMG 552) • lirafugratinib (RLY-4008) • LOXO-435
1m
FGF9, a Potent Mitogen, Is a New Ligand for Integrin αvβ3, and the FGF9 Mutant Defective in Integrin Binding Acts as an Antagonist. (PubMed, Cells)
R108E suppressed DNA synthesis and activation of FRS2α and ERK1/2 induced by WT FGF9 (dominant-negative effect). These findings indicate that FGF9 requires direct integrin binding for signaling and that R108E has potential as an antagonist to FGF9 signaling.
Journal
|
FGFR (Fibroblast Growth Factor Receptor) • FGF2 (Fibroblast Growth Factor 2)
|
FGFR mutation
1m
Pilocytic astrocytoma: The paradigmatic entity in low‑grade gliomas (Review). (PubMed, Oncol Lett)
Finally, if PA recurs, a new surgical approach should be performed. At present, novel therapy involving agents targeting MAPK signalling pathway dysregulation is in development, defining BRAF and MEK inhibitors as target therapeutical agents.
Review • Journal
|
KRAS (KRAS proto-oncogene GTPase) • FGFR1 (Fibroblast growth factor receptor 1) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • KRAS mutation • BRAF V600 • NF1 mutation • FGFR mutation • FGFR1 mutation
1m
RAGNAR: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=316, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Sep 2024 --> Oct 2023
Trial primary completion date • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Balversa (erdafitinib)
2ms
Trial completion • Enrollment change • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR (Fibroblast Growth Factor Receptor)
|
EGFR mutation • IDH1 mutation • ALK rearrangement • FGFR mutation
|
pimivalimab (JTX-4014) • polzastobart (JTX-8064)
2ms
Identification of Piperazinyl-Difluoro-indene Derivatives Containing Pyridyl Groups as Potent FGFR Inhibitors against FGFR Mutant Tumor: Design, Synthesis, and Biological Evaluation. (PubMed, J Med Chem)
Moreover, compound (S)-23 exhibited favorable pharmacokinetic properties, low potential for drug-drug interactions, and very potent antitumor activity in MFE-296 xenograft mouse models with a TGI of 99.1% at the dose of 10 mg/kg. These findings demonstrate that compound (S)-23 is a potential therapeutic agent for FGFR mutant tumors.
Journal
|
FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR4 (Fibroblast growth factor receptor 4)
|
FGFR1 amplification • FGFR2 mutation • FGFR2 fusion • FGFR2 amplification • FGFR mutation • FGFR1 fusion • FGFR3 fusion • FGFR4 mutation
2ms
Renal Retention in High Grade Upper Tract Urothelial Cancer (clinicaltrials.gov)
P2, N=20, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2027
Trial completion date • Trial primary completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
3ms
NCCH2006/MK010 Trial (FORTUNE Trial) (clinicaltrials.gov)
P2, N=46, Active, not recruiting, National Cancer Center, Japan | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • FGFR4 (Fibroblast growth factor receptor 4) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • BRAF mutation • NRAS mutation • BRAF V600 • FGFR1 amplification • FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR2 N549K • FGFR1 fusion • FGFR3 fusion • FGFR2 P253R • FGFR2 K310R • FGFR3 Y375C • FGFR2 C382R • FGFR2 N549D • FGFR2 N549H • FGFR2 S252W • FGFR2 Y375C • FGFR3 G380R • FGFR3 K650E • FGFR2 W290C
|
tasurgratinib (E7090)
3ms
Structural basis and selectivity of sulfatinib binding to FGFR and CSF-1R. (PubMed, Commun Chem)
The insensitivity of sulfatinib to FGFR gatekeeper mutations highlights the indispensable interactions with the hydrophobic pocket for FGFR selectivity, whereas the rotatory flexibility may enable sulfatinib to overcome CSF-1R. This study not only sheds light on the structural basis governing sulfatinib's FGFR/CSF-1R inhibition, but also provides valuable insights into the rational design of dual- or multi-target FGFR inhibitors with selectivity for CSF-1R and sensitivity to gatekeeper mutations.
Journal
|
FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor) • CSF1R (Colony stimulating factor 1 receptor)
|
FGFR mutation
|
Sulanda (surufatinib)
4ms
Comparison of tissue based FGFR mutation detection by Therascreen FGFR with UroTyper FGFR and ADC test and relevance for potential co-targeting with TROP2 and NECTIN4: Preview of Bladder BRIDGister. (ASCO-GU 2024)
Background: In view of the efficacy of FGFR targeting in early and advanced bladder cancer, as has been shown for erdafitinib in the THOR and NORSE trial, molecular testing of FGFR mutations and fusions will soon become clinical routine worldwide... PCR-based FGFR assessment by Therascreen and UroTyper is highly concordant and enables fast, local FGFR assessment within few hours. FGFR3 mutations are associated with increased TROP2 & NECTIN4 expression indicating potential synergistic options which warrants further exploration as part of molecularly stratified clinical trials.
FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • PPARG (Peroxisome Proliferator Activated Receptor Gamma) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
|
FGFR3 mutation • FGFR mutation • FGFR fusion • FGFR3 S249C • FGFR3 overexpression • FGFR3 Y373C • NECTIN4 expression • FGFR3 G370C • FGFR3 R248C • FGF3 overexpression
|
therascreen® FGFR RGQ RT-PCR Kit • Uromonitor®
|
Balversa (erdafitinib)
4ms
A phase II telemedicine study of pemigatinib in adult patients with unresectable or metastatic pancreas cancer with FGFR2 gene fusions or other FGFR genetic alterations. (ASCO-GI 2024)
FGFR kinase inhibitorshave the potential to be an effective targeted therapy in pancreas cancer. Additionally, telemedicine is a novel tool that can aid in the study of ultra-rare cancers and reduce barriers to patient participation in clinical trials.
Clinical • P2 data • Metastases
|
FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1)
|
FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR fusion • FGFR1 fusion
|
Pemazyre (pemigatinib)
4ms
First-308: Phase III study of tinengotinib versus physician's choice in patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory/relapsed cholangiocarcinoma. (ASCO-GI 2024)
The first generation FGFR inhibitors (FGFRi) pemigatinib and futibatinib, have been approved for the treatment of advanced CCA with FGFR2 fusions or rearrangements after systemic chemotherapy...The study includes Part A and Part B. The Part A is to select a dose for Part B. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice (FOLFOX or FOLFIRI) in Part A or 2:1 in Part B to receive the recommended Part B dose or Physician's Choice...Study is open for enrollment. Clinical trial information: NCT05948475.
Clinical • P3 data
|
FGFR2 (Fibroblast growth factor receptor 2)
|
FGFR2 mutation • FGFR2 fusion • FGFR mutation
|
5-fluorouracil • Lytgobi (futibatinib) • irinotecan • Pemazyre (pemigatinib) • tinengotinib (TT-00420) • leucovorin calcium
4ms
TAR-210: A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer (clinicaltrials.gov)
P1, N=6, Recruiting, Janssen Pharmaceutical K.K. | Trial completion date: Oct 2026 --> Jul 2027
Trial completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
erdafitinib intravesical delivery system (TAR-210)
4ms
Phase classification • Metastases
|
FGFR mutation
|
Balversa (erdafitinib)
4ms
Trial completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
gemcitabine • Balversa (erdafitinib) • mitomycin
5ms
Trial completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
gemcitabine • Balversa (erdafitinib) • mitomycin
5ms
FGFR alterations in gliomas; clinical, radiographic and molecular characterization (SNO 2023)
FGFR3-TACC3 fusions (F3T3) gliomas represent a unique entity among IDH WT gliomas. In our cohort, 100% of the patients with F3T3-positive glioblastomas also had an associated TERT promoter mutation. To our knowledge, this is one of the larger cohorts showing the association between FGFR3 and TERT promoter alterations in glioblastomas.
Clinical
|
FGFR3 (Fibroblast growth factor receptor 3) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • FGFR (Fibroblast Growth Factor Receptor) • TERT (Telomerase Reverse Transcriptase) • TACC3 (Transforming acidic coiled-coil containing protein 3) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • LMNB2 (Lamin B2)
|
FGFR3-TACC3 fusion • FGFR mutation • CDKN2A mutation • FGFR fusion • FGFR3 fusion • TERT mutation • IDH wild-type • TERT promoter mutation • FGFR3 amplification
5ms
Implementing genomic profiling as standard-of-care for glioblastoma patients. (SNO 2023)
Genomic profiling revealed actionable targets and new therapeutic options for glioblastoma pts. A full and updated overview of patient characteristics, actionable targets and survival data will be presented at the meeting.
Clinical
|
TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • FGFR (Fibroblast Growth Factor Receptor) • NTRK (Neurotrophic receptor tyrosine kinase)
|
BRAF V600E • TMB-H • FGFR mutation • FGFR fusion • MET mutation • PDGFRA mutation • NTRK fusion • PDGFRA fusion
5ms
FGFR alterations in gliomas; clinical, radiographic and molecular characterization (SNO 2023)
FGFR3-TACC3 fusions (F3T3) gliomas represent a unique entity among IDH WT gliomas. In our cohort, 100% of the patients with F3T3-positive glioblastomas also had an associated TERT promoter mutation. To our knowledge, this is one of the larger cohorts showing the association between FGFR3 and TERT promoter alterations in glioblastomas.
Clinical
|
FGFR3 (Fibroblast growth factor receptor 3) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • FGFR (Fibroblast Growth Factor Receptor) • TERT (Telomerase Reverse Transcriptase) • TACC3 (Transforming acidic coiled-coil containing protein 3) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • LMNB2 (Lamin B2)
|
FGFR3-TACC3 fusion • FGFR mutation • CDKN2A mutation • FGFR fusion • FGFR3 fusion • TERT mutation • IDH wild-type • TERT promoter mutation • FGFR3 amplification
5ms
Trial completion date • Metastases
|
FGFR mutation
|
Balversa (erdafitinib)
5ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon)
|
PD-L1 expression • MSI-H/dMMR • FGFR mutation • FGFR1 mutation
|
Pemazyre (pemigatinib) • Zynyz (retifanlimab-dlwr) • epacadostat (INCB024360) • INCAGN2390 • tuparstobart (INCAGN2385)
5ms
Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma (clinicaltrials.gov)
P2, N=55, Active, not recruiting, TransThera Sciences (Nanjing), Inc. | Recruiting --> Active, not recruiting | N=80 --> 55 | Trial completion date: Sep 2023 --> May 2024 | Trial primary completion date: Sep 2023 --> May 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
FGFR2 (Fibroblast growth factor receptor 2) • FGFR (Fibroblast Growth Factor Receptor)
|
FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR1 mutation • FGFR1 fusion • FGFR wild-type
|
tinengotinib (TT-00420)
5ms
Functional Distinctions of Endometrial Cancer-Associated Mutations in the Fibroblast Growth Factor Receptor 2 Gene. (PubMed, Cells)
By unraveling the distinct effects of different mutations, our study contributes to the identification of personalized treatment strategies for patients with FGFR2-mutated cancers. This knowledge has the potential to guide the development of targeted therapies that specifically address the underlying molecular alterations associated with FGFR2 mutations, ultimately improving patient outcomes in EC and potentially other cancer types characterized by FGFR2 mutations.
Journal
|
EGFR (Epidermal growth factor receptor) • FGFR2 (Fibroblast growth factor receptor 2) • ADAM17 (ADAM Metallopeptidase Domain 17)
|
FGFR2 mutation • FGFR mutation
6ms
RAGNAR: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=316, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2026 --> Sep 2024 | Trial primary completion date: Jan 2025 --> Sep 2024
Trial completion date • Trial primary completion date • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Balversa (erdafitinib)
6ms
Atypical presentation of dysembryoplastic neuroepithelial tumor in an adult without epilepsy: a case report. (PubMed, Int J Neurosci)
In this case, the absence of seizure onset may be attributed to the lack of cortical dysplasia. Further research is needed to understand the incidence of DNETs and their association with seizure onset and cortical dysplasia.
Journal
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
6ms
Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT. (clinicaltrials.gov)
P2, N=22, Active, not recruiting, Sameek Roychowdhury | Unknown status --> Active, not recruiting | N=45 --> 22 | Trial completion date: Dec 2021 --> Nov 2023 | Trial primary completion date: Dec 2021 --> Nov 2022
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
FLT3 (Fms-related tyrosine kinase 3) • ABL1 (ABL proto-oncogene 1) • RET (Ret Proto-Oncogene) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Iclusig (ponatinib)
7ms
Avelumab as First-Line Maintenance Treatment in Locally Advanced or Metastatic Urothelial Carcinoma. (PubMed, Adv Ther)
The National Comprehensive Cancer Network, European Association of Urology and European Society for Medical Oncology guidelines recommend first-line cisplatin-containing chemotherapy for cisplatin-eligible patients, carboplatin-gemcitabine for cisplatin-ineligible patients who are fit for carboplatin, or immunotherapy with programmed death ligand-1 (PD-L1) inhibitors (e.g. atezolizumab) in platinum-ineligible patients...In patients who relapse after/during chemotherapy, options include immunotherapy, erdafitinib [in those with fibroblast growth factor receptor (FGFR) mutations], enfortumab vedotin or further chemotherapy. The expert panel provided the following practical guidance: (1) consider maintenance avelumab in all eligible patients; (2) continue avelumab until disease progression/unacceptable toxicity; (3) ideally, administer six cycles of platinum-based chemotherapy prior to maintenance avelumab; (4) perform radiological evaluation after four chemotherapy cycles and prior to maintenance avelumab; (5) carboplatin-gemcitabine followed by maintenance avelumab is preferred in cisplatin-ineligible patients (regardless of PD-L1 expression), but consider first-line immunotherapy in PD-L1-positive patients and platinum-ineligible patients (regardless of PD-L1 status); and (6) for patients who relapse on avelumab, second-line options include enfortumab vedotin, FGFR inhibitors (in those with FGFR mutations) or clinical trial inclusion. In conclusion, avelumab maintenance therapy is recommended following platinum-based chemotherapy in all eligible patients with locally advanced or metastatic UC, continued until disease progression or unacceptable toxicity.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 expression • FGFR mutation
|
Tecentriq (atezolizumab) • carboplatin • gemcitabine • Bavencio (avelumab) • Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
7ms
Resistance to selective FGFR inhibitors in FGFR-driven urothelial cancer. (PubMed, Cancer Discov)
In patient-derived models, erdafitinib was synergistic with pictilisib in the presence of PIK3CA E545K, whereas erdafitinib-gefitinib combination was able to overcome bypass resistance mediated by EGFR activation. Eleven (52%) patients harbored alterations in the PI3K-mTOR pathway (n = 5 TSC1/2, n = 5 PIK3CA, n = 1 NF2, n = 1 PTEN). In patient-derived models, erdafitinib was synergic with pictilisib in the presence of PIK3CA E545K, while erdafitinib-gefitinib combination was able to overcome bypass resistance mediated by EGFR activation.
Journal
|
EGFR (Epidermal growth factor receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR2 (Fibroblast growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • FGFR3 (Fibroblast growth factor receptor 3) • TSC1 (TSC complex subunit 1)
|
FGFR2 mutation • PIK3CA E545K • FGFR mutation • TSC1 mutation • PIK3CA E545
|
gefitinib • Balversa (erdafitinib) • pictilisib (GDC-0941)
8ms
RAGNAR: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=316, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2028 --> Sep 2026 | Trial primary completion date: Dec 2027 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Balversa (erdafitinib)
8ms
Enrollment closed
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
gemcitabine • Balversa (erdafitinib) • mitomycin
8ms
New Era of Immune-Based Therapy in Intrahepatic Cholangiocarcinoma. (PubMed, Cancers (Basel))
In 2022, a multicenter, double-blind, randomized phase 3 trial (TOPAZ-1 trial) examined the addition of programmed death-ligand 1 immunotherapy (durvalumab) to combination gemcitabine + cisplatin for BTC treatment, resulting in significantly improved survival without notable additional toxicity. Mutations in fibroblast growth factor receptor 1/2/3, isocitrate dehydrogenase 1/2, and neurotrophic tyrosine receptor kinase A/B/C are relatively frequent in intrahepatic CC, and precision medicines are available that can target associated pathways. In this review, we suggest strategies for systemic pharmacotherapy with a focus on intrahepatic CC, in addition to presenting the results and safety outcomes of clinical trials evaluating immune checkpoint inhibitor therapies in BTC.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • FGFR1 (Fibroblast growth factor receptor 1)
|
FGFR mutation • FGFR1 mutation
|
cisplatin • Imfinzi (durvalumab) • gemcitabine
8ms
Efficacy and safety of erdafitinib in adults with pancreatic cancer and prespecified fibroblast growth factor receptor alterations (FGFRalt) in the phase II open-label: Single-arm RAGNAR trial (ESMO 2023)
Conclusions Erda demonstrated robust and clinically meaningful activity in pancreatic cancer pts with FGFRalt. Safety data were consistent with erda safety profile.
Clinical • P2 data
|
KRAS (KRAS proto-oncogene GTPase) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • FGFR1 (Fibroblast growth factor receptor 1) • FGFR (Fibroblast Growth Factor Receptor)
|
KRAS mutation • FGFR2 mutation • FGFR2 fusion • FGFR mutation • FGFR1 mutation • FGFR fusion • FGFR1 fusion
|
Balversa (erdafitinib)
8ms
FIND: A phase II study to evaluate the efficacy of erdafitinib in FGFR-altered NSCLC (ESMO 2023)
Conclusions According to the first stage results of the two-stage Simon's design, erdafitinib showed preliminary efficacy in NSCLC with FGFR translocations. Further molecular, pharmacological and clinical data are needed to evaluate the efficacy of FGFR inhibition in NSCLC, especially in pts with FGFR mutations.
Clinical • P2 data
|
FGFR3 (Fibroblast growth factor receptor 3) • FGFR (Fibroblast Growth Factor Receptor) • TACC3 (Transforming acidic coiled-coil containing protein 3)
|
FGFR3-TACC3 fusion • FGFR mutation • FGFR3 fusion
|
Balversa (erdafitinib)
8ms
Building a new prognostic score for patients with central nervous system (CNS) tumors enrolled in early phase clinical trials (ESMO 2023)
In multivariate analysis, lymphocyte counts ≥900/mm3 (HR=0.7 95% CI 0.46 - 1.07), absence of steroids at baseline (HR=2.3 95% CI 1.5 - 3.5), absence of antiepileptic drugs at baseline (HR=2.06 95%CI 1.2 - 3.7) were associated with a better overall survival. Conclusions Corticosteroid use, lymphocyte count and use of antiepileptics will be used to build a new score that will be presented at the conference.
Clinical • IO biomarker
|
BRAF (B-raf proto-oncogene) • FGFR (Fibroblast Growth Factor Receptor) • MGMT (6-O-methylguanine-DNA methyltransferase)
|
BRAF mutation • FGFR mutation • FGFR fusion
8ms
Impact of oncogenic fibroblast growth factor receptor (FGFR) alterations in patients with advanced solid tumors in a real-world setting (ESMO 2023)
Conclusions There was no statistically significant difference in RW OS between pts with FGFR+ or FGFRadv/ met solid tumors, with a median OS of ∼1 year in both groups. These results highlight the poor prognosis and high unmet need for novel, targeted tx.
Clinical • Real-world evidence • Real-world • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion • FGFR wild-type
8ms
A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC): In-Depth Analysis of Nintendanib Arm from the KCSG HN 15-16 TRIUMPH Trial. (PubMed, Cancer Res Treat)
The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of small number of patients due to slow accrual in this study, further studies with large cohort are warranted for statistical power.
P2 data • Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation
|
nintedanib
8ms
RAGNAR: A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (clinicaltrials.gov)
P2, N=316, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Balversa (erdafitinib)