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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Javlor (vinflunine)
i
Other names: BMS-710485, F-12158, L0070 , BMS710485, BMS 710485, F12158, F 12158, L-0070, L 0070
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News alerts, weekly reports and conference planners
Company:
Pierre Fabre
Drug class:
Microtubule inhibitor
Related drugs:
10d
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (clinicaltrials.gov)
P3, N=608, Completed, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Completed
Trial completion
|
paclitaxel • docetaxel • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
5ms
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (clinicaltrials.gov)
P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Aug 2025 --> Nov 2025
Trial completion date
|
paclitaxel • docetaxel • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
6ms
TROPiCS-04: Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
P3, N=712, Completed, Gilead Sciences | Active, not recruiting --> Completed
Trial completion
|
paclitaxel • docetaxel • Trodelvy (sacituzumab govitecan-hziy) • Javlor (vinflunine)
8ms
Erdafitinib versus Chemotherapy in Fibroblast Growth Factor Receptor-Altered Advanced or Metastatic Urothelial Cancer After Progression on Anti-programmed Death-(Ligand) 1 Therapy: An Exploratory Analysis of the Asian Subpopulation in the THOR Phase 3 Study. (PubMed, Clin Genitourin Cancer)
Erdafitinib showed improved survival compared with chemotherapy, with no new safety concerns in the Asian subpopulation. These findings were consistent with those for the overall study population in THOR Cohort 1 who received prior anti-PD-(L)1 therapy.
P3 data • Journal
|
FGFR (Fibroblast Growth Factor Receptor)
|
docetaxel • Balversa (erdafitinib) • Javlor (vinflunine)
9ms
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (clinicaltrials.gov)
P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Apr 2025 --> Aug 2025
Trial completion date
|
paclitaxel • docetaxel • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
12ms
TROPiCS-04: Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
P3, N=696, Active, not recruiting, Gilead Sciences | Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jul 2025 --> Oct 2025
Trial completion date • Trial primary completion date
|
paclitaxel • docetaxel • Trodelvy (sacituzumab govitecan-hziy) • Javlor (vinflunine)
over1year
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (clinicaltrials.gov)
P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Aug 2024 --> Feb 2025
Trial completion date • Metastases
|
paclitaxel • docetaxel • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
over1year
TROPiCS-04: Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
P3, N=696, Active, not recruiting, Gilead Sciences | Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Oct 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Metastases
|
paclitaxel • docetaxel • Trodelvy (sacituzumab govitecan-hziy) • Javlor (vinflunine)
over1year
Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Erdafitinib vs Enfortumab Vedotin in Patients with Locally Advanced Metastatic Urothelial Carcinoma. (PubMed, J Health Econ Outcomes Res)
An anchored MAIC was conducted according to the National Institute for Health and Care Excellence Decision Support Unit guidance, with physician's choice of chemotherapy (docetaxel/paclitaxel and vinflunine) as the common comparator. The MAIC indicates comparable efficacy of erdafitinib vs EV for overall survival and progression-free survival, with erdafitinib showing a higher probability of achieving deep responses. While erdafitinib is associated with slightly more adverse events compared with EV, these events seem to be less severe.
Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
paclitaxel • docetaxel • Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
over1year
Paradigm shift in systemic therapy for metastatic urothelial carcinoma-antibody-drug conjugates (ADCs) and fibroblast growth factor receptor (FGFR) inhibitors (PubMed, Urologie)
These novel combinations are revolutionizing the treatment standard for metastatic urothelial carcinoma and necessitate a new approach to managing side effects.
Review • Journal • PD(L)-1 Biomarker • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • gemcitabine • Bavencio (avelumab) • Balversa (erdafitinib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
over1year
Phase 3 THOR Japanese subgroup analysis: erdafitinib in advanced or metastatic urothelial cancer and fibroblast growth factor receptor alterations. (PubMed, Int J Clin Oncol)
In the Japanese subgroup, erdafitinib showed improved survival and response compared to chemotherapy, with no new safety concerns. These results support erdafitinib as a treatment option for Japanese mUC patients with FGFR alterations, and early FGFR testing after diagnosis of mUC should be considered.
P3 data • Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
docetaxel • Balversa (erdafitinib) • Javlor (vinflunine)
over1year
THOR: A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (clinicaltrials.gov)
P3, N=629, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2024 --> Nov 2026
Trial completion date • Metastases
|
Keytruda (pembrolizumab) • docetaxel • Balversa (erdafitinib) • Javlor (vinflunine)
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