FIERCE-22: Clinical activity of vofatamab (V) a FGFR3 selective inhibitor in combination with pembrolizumab (P) in WT metastatic urothelial carcinoma, preliminary analysis.
Abstract
4511 Background: Patients (pts) with mUC who have failed platinum-based chemotherapy have a poor prognosis. Reported response rates to immune checkpoint inhibitors (ICI) are approximately 20%. 20% of pts with mUC harbor FGFR3 mutations or fusions (M/F), which may result in lower sensitivity to ICI. V (B-701) is a fully human monoclonal antibody against FGFR3 that blocks activation of both the wildtype and genetically activated receptor. This is a Phase 1b/2 study designed to evaluate V monotherapy window followed in combination of V with P(VP) (NCT03123055). Methods: This trial enrolled mUC pts with failure to ≥ 1 prior line of chemotherapy or recurrence ≤ 12 months of (neo)adjuvant chemotherapy, measurable disease and ECOG <2. Treatment consisted of v at 25 mg/kg alone for 2 week monotherapy window followed by combination with P 200 mg q3w.during the V window paired tumor biopsy were obtained. Efficacy was assessed by investigators (RECIST 1.1). Primary objectives were safety and activity [ORR]). Results: 35 pts have received treatment (Ph1b:8, WT:20, M/F+: 7). WT patients were unselected for PD-1 status, predominately male (55%) white (95%), all had received at least 1 line of prior chemo and 60% had Bellmunt scores of > 1. The safety profile is consistent with previously reported data for P. TEAE occurring in >20% of patients were nausea, anemia, diarrhea and fatigue. Six WT patients (30%) had responses (4 confirmed responses, 1 unconfirmed), and an additional patient with an iRECIST response. Responses occurred at a median of 3.5 months. At 4+ months of follow up, 13(65%) remain on treatment @ a median of 8 cycles (range: 1-13). At 5+ months the median PFS has not been reached. Conclusions: VP combination therapy is well tolerated with an encouraging ORR and prolonged PFS in the WT cohort; greater than one would anticipate from P alone based upon historical data. We will be reporting 9+ month preliminary PFS/OS and updated OOR/DOR data. Clinical trial information: NCT03123055.
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Preliminary results of phase 1/2 study NCT03123055 demonstrated that vofatamab plus pembrolizumab had an encouraging effect in FGFRWT metastatic urothelial carcinoma.
“Besides, the preliminary results of phase 1/2 study NCT03123055 demonstrated that vofatamab (FGFR inhibitor) plus pembrolizumab had an encouraging effect in FGFRWT metastatic urothelial carcinoma [237].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [237]
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“Besides, the preliminary results of phase 1/2 study NCT03123055 demonstrated that vofatamab (FGFR inhibitor) plus pembrolizumab had an encouraging effect in FGFRWT metastatic urothelial carcinoma [237].”
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BackgroundTargeted therapies for advanced bladder cancer: new strategies with FGFR inhibitors
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“Vofatamab + pembrolizumab FGFR target therapy I/II NCT03123055 (FIERCE-22) [77] Second-line Safety, toxicity, and ORR”
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“Vofatamab was also being evaluated in another phase Ib/II trial in combination with pembrolizumab in metastatic UC in patients who had progressed on chemotherapy (NCT03123055) [66].”
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“179,180 However, clinical trials evaluating FGFR inhibitors in combination with ICI in HR-NMIBC are lacking.”
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“Some of these were reported [88,89], and others are ongoing (Table 3).”
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“63 This approach is similar to the use of DNA damage response (DDR) gene targeting in prostate cancer.”
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“rated in large-scale studies with UC patients [47].”
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Dizman, N., Meza, L. A., & Pal, S. K. (2021) · Nature Medicine · doi:10.1038/s41591-021-01300-1 · Cited by 7 · see citing works
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FGFR-gerichtete Therapie von Kopf-Hals-Karzinomen
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BackgroundGenomic Profiling and Molecular Characterisation of Metastatic Urothelial Carcinoma
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“Importantly, clinical experience with the FGFR3-blocking antibody vofatamab, which is a strong inhibitor of physiologic, ligand-dependent FGFR3 signaling, indicates that specific FGFR3 blockade does not lead to hyperphosphatemia, or nail or ocular toxicity (12).”
Emerging treatments in advanced urothelial cancer
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- Authors
- Siefker-Radtke, A. O., Currie, G., Abella, E., Vaena, D. A., Rezazadeh Kalebasty, A., Curigliano, G., Tupikowski, K., Andric, Z. G., Lugowska, I., & Kelly, W. K.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Rainier Therapeutics Inc, San Leandro, CA;
- Instituto Tecnologico de Nuevo Laredo (MX)
- University of Iowa Hospitals and Clinics (US)
- Norton Cancer Institute, Louisville, KY;
- University of Milan (IT)
- Dolnośląskie Centrum Onkologii (PL)
- Clinical Hospital Center, Bezanijska Kosa, Belgrade, Serbia;
- The Maria Sklodowska-Curie National Research Institute of Oncology (PL)
- Thomas Jefferson University (US)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2019-05-20
- Volume
- 37
- Issue
- 15_suppl
- Pages
- 4511-4511
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2947906325
- Cited by
- 64
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 8 · 2023: 7 · 2022: 11 · 2021: 16 · 2020: 14 · 2019: 5
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Fibroblast Growth Factor Research
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- FGFR3 inhibitors, pembrolizumab, metastatic urothelial carcinoma, FGFR3 mutation, FGFR3 fusion, immune checkpoint inhibitor resistance, combination therapy, objective response rate, progression-free survival, treatment safety
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