Javlor (vinflunine) / Pierre Fabre - LARVOL DELTA

Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. (PubMed, N Engl J Med) - P3 | "Enfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based treatment and a PD-1 or PD-L1 inhibitor. (Funded by Astellas Pharma US and Seagen; EV-301 ClinicalTrials.gov number, NCT03474107.)."

Journal • Oncology • Solid Tumor • Urothelial Cancer

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=630 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P=N/A ➔ P3

Phase classification

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Mar 2023 ➔ Oct 2023

Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Dec 2021 ➔ May 2021

Trial completion date

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2021 ➔ Feb 2027 | Trial primary completion date: Nov 2020 ➔ Apr 2024

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Oct 2033

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2027 ➔ Apr 2024

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Oct 2023 | Trial primary completion date: Apr 2024 ➔ Oct 2022

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2033 ➔ Apr 2024

Enrollment closed • Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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) - P=N/A | N=N/A | Withheld | Sponsor: [Redacted]

New trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Sponsor: Janssen Research & Development, LLC | Trial completion date: Sep 2024 ➔ Nov 2026

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Feb 2024 ➔ Sep 2024

Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2021 ➔ Nov 2021

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=630 | Not yet recruiting | Sponsor: Janssen Research & Development, LLC

New P3 trial • Genito-urinary Cancer • Oncology • Solid Tumor

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2023 ➔ Apr 2026

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Feb 2023 ➔ Nov 2021

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: May 2021 ➔ Feb 2021

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Nov 2021 ➔ Feb 2023

Trial completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2024 ➔ Aug 2024 | Trial primary completion date: Oct 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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=631 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2026 ➔ Apr 2024 | Trial primary completion date: Oct 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

TroFuse-031: A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) (clinicaltrials.gov) - P3 | N=590 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Use of early dynamics of clinical and laboratory parameters to predict resistance in patients with metastatic urothelial carcinoma receiving post-platinum atezolizumab (AACR 2024) - "We investigated readily available baseline and EOT variables from the phase 3 clinical trial IMvigor211, which compared atezolizumab, a PD-L1 inhibitor, with chemotherapy (taxane or vinflunine), in patients with mUC who have progressed on platinum-based chemotherapy. Of 931 patients in IMvigor211, 902 were evaluable for our analysis...The strongest baseline predictors are PD-L1 expression, prior treatment with both cisplatin and carboplatin, and the presence of liver metastases... Our prediction models employing readily available and affordable EOT clinical and laboratory variables robustly (AUC 0.83) identified patients with early resistance and may inform patient-specific therapeutic decisions. Further validation is required."

Clinical • IO biomarker • Metastases • Oncology • Solid Tumor • Urothelial Cancer

FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. (PubMed, J Clin Oncol) - P2/3 | "To our knowledge, these are the first data to compare FGFR-directed therapy with chemotherapy in patients with FGFR-altered UC, showing comparable efficacy and manageable safety. Exploratory testing suggested FGFR3 DNA alterations in association with FGFR1/3 mRNA overexpression may be better predictors of rogaratinib response."

Journal • P2/3 data • Oncology • Solid Tumor • Urothelial Cancer • FGFR1 • FGFR3

Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. (PubMed, Ann Oncol) - P3 | "SG did not result in a significant improvement in OS or PFS compared with TPC in pretreated aUC, although SG activity was demonstrated by a higher ORR. Early toxicity-related complications with SG may have impacted efficacy outcomes."

Journal • P3 data • Bladder Cancer • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Infectious Disease • Neutropenia • Oncology • Solid Tumor • Urothelial Cancer