Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma
Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with -a...
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| Published in | New England Journal of Medicine Vol. 389; no. 21; pp. 1961 - 1971 |
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| Main Authors | , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
23.11.2023
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible
alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with
-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.
We conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible
alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator's choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.
A total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = 0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).
Erdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and
alterations after previous anti-PD-1 or anti-PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.). |
|---|---|
| AbstractList | Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible
alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with
-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.
We conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible
alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator's choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.
A total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = 0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).
Erdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and
alterations after previous anti-PD-1 or anti-PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.). Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.BACKGROUNDErdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti-programmed cell death protein 1 [PD-1] or anti-programmed death ligand 1 [PD-L1] agents) are unclear.We conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator's choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.METHODSWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti-PD-1 or anti-PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator's choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.A total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = 0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).RESULTSA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = 0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).Erdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti-PD-1 or anti-PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.).CONCLUSIONSErdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti-PD-1 or anti-PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.). AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear.MethodsWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.ResultsA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).ConclusionsErdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD-1 or anti–PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.) |
| Author | Arlene O, Siefker-Radtke Ben, Tran Severine, Banek Sydney, Akapame Nobuaki, Matsubara Robert A, Huddart Spyros, Triantos Sutapa, Mukhopadhyay Nicole L, Stone Yohann, Loriot Earle F, Burgess Begoña P, Valderrama Yin, Kean Ja Hyeon, Ku Arlene, Siefker-Radtke Valentina, Guadalupi Kris, Deprince Se Hoon, Park Nadine, Houede |
| Author_xml | – sequence: 1 fullname: Yohann, Loriot – sequence: 2 fullname: Nobuaki, Matsubara – sequence: 3 fullname: Se Hoon, Park – sequence: 4 orcidid: 0000-0003-3604-1990 fullname: Robert A, Huddart – sequence: 5 fullname: Earle F, Burgess – sequence: 6 fullname: Nadine, Houede – sequence: 7 fullname: Severine, Banek – sequence: 8 fullname: Valentina, Guadalupi – sequence: 9 fullname: Ja Hyeon, Ku – sequence: 10 fullname: Begoña P, Valderrama – sequence: 11 fullname: Ben, Tran – sequence: 12 fullname: Spyros, Triantos – sequence: 13 fullname: Yin, Kean – sequence: 14 fullname: Sydney, Akapame – sequence: 15 fullname: Kris, Deprince – sequence: 16 fullname: Sutapa, Mukhopadhyay – sequence: 17 fullname: Nicole L, Stone – sequence: 18 fullname: Arlene O, Siefker-Radtke – sequence: 19 fullname: Arlene, Siefker-Radtke |
| BackLink | https://cir.nii.ac.jp/crid/1873961342259052928$$DView record in CiNii https://www.ncbi.nlm.nih.gov/pubmed/37870920$$D View this record in MEDLINE/PubMed https://hal.science/hal-04501602$$DView record in HAL |
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| ContentType | Journal Article |
| Contributor | Prédicteurs moléculaires et nouvelles cibles en oncologie (PMNCO) ; Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay Nishiyama, Hiroyuki Liu, Jiyan Luque, Raquel He, Dalin Kim, SeHyun Wuelfing, Christian Uemura, Hirotsugu Korbenfeld, Ernesto Tosi, Diego Houede, Nadine Bastick, Patricia Laguerre, Brigitte Huang, Jian Barthelemy, Philippe Galli, Luca Xue, Wei Tran, Ben Gervais, Claire Loidl, Wolfgang Kopyltsov, Evgeny Ferguson, Thomas Schrijvers, Dirk Rikiya, Taoka Cornillon, Pierre Giorgi, Ugo De Harabayashi, Toru Schatteman, Peter Kojima, Takahiro Barros Leite Ferreira, Luiza Aleixo Scagliotti, Giorgio Beardsley, Emma Kobayashi, Keita Cutuli, Hernán Alekseev, Boris Matus, Geoffroy Guadalupi, Valentina Tortora, Giampaolo Basso, Umberto Nuhn, Philipp Cavo, Alessia Lim, Seung Taek Karalis, Konstantinos Menezes, Juliana Rottey, Sylvie Ku, Ja Hyeon Feijter, Jeantine de Eigl, Bernhard Pouessel, Damien Nishimura, Kazuo Yamamoto, Hayato Xu, Ting Roubaud, Guilhem Girones, Regina Park, Joohwan Bearz, Alessandra Los, Maartje Junior, Joao Neif Antonio Méndez Vidal, María Jose Gonzalez-Del-Alba, Aranzazu Font, Albert Shimizu, Nobuaki Miura, Yuji Peer, Avivit Gomez de Liañ, A |
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| Snippet | Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in... AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic... |
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| SubjectTerms | [SDV]Life Sciences [q-bio] Adult Antibodies, Monoclonal, Humanized Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Apoptosis Cancer therapies Carcinoma, Transitional Cell Carcinoma, Transitional Cell - drug therapy Carcinoma, Transitional Cell - mortality Carcinoma, Transitional Cell - pathology Cell death Chemotherapy Confidence intervals Docetaxel Docetaxel - adverse effects Docetaxel - therapeutic use Fibroblast growth factor receptors Humans Immune Checkpoint Inhibitors Immune Checkpoint Inhibitors - adverse effects Immune Checkpoint Inhibitors - therapeutic use Kinases Life Sciences Metastases Metastasis Mutation Patients PD-1 protein PD-L1 protein Receptors, Fibroblast Growth Factor Receptors, Fibroblast Growth Factor - antagonists & inhibitors Tumors Urinary Bladder Neoplasms Urinary Bladder Neoplasms - drug therapy Urinary Bladder Neoplasms - mortality Urinary Bladder Neoplasms - pathology Urological cancer Urothelial carcinoma |
| Title | Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma |
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