Infigratinib in early-line and salvage therapy for FGFR3-altered metastatic urothelial carcinoma Journal Article
| Authors: | Lyou, Y.; Rosenberg, J. E.; Hoffman-Censits, J.; Quinn, D. I.; Petrylak, D.; Galsky, M.; Vaishampayan, U.; De Giorgi, U.; Gupta, S.; Burris, H.; Rearden, J.; Li, A.; Xu, C.; Andresen, C.; Moran, S.; Daneshmand, S.; Bajorin, D.; Pal, S. K.; Grivas, P. |
| Article Title: | Infigratinib in early-line and salvage therapy for FGFR3-altered metastatic urothelial carcinoma |
| Abstract: | Introduction: To describe the efficacy of infigratinib, a potent, selective fibroblast growth factor receptor (FGFR) 1-3 tyrosine kinase inhibitor, across lines of therapy (LOT) in patients with metastatic urothelial cancer (mUC). Patients and Methods: Eligible patients had mUC and prior platinum-based chemotherapy, unless contraindicated, and activating FGFR3 mutation/fusion. Patients received infigratinib 125 mg orally daily (3 weeks on/1 week off) in a single-arm, open-label study. Primary endpoint: investigator-assessed confirmed objective response rate (ORR). Disease control rate (DCR), progression-free survival (PFS), best overall response (BOR) that included unconfirmed responses, and overall survival (OS) were also assessed. Subgroup analysis of efficacy and safety outcomes by LOT was performed. Results: Sixty-seven patients were enrolled; 13 (19.4%) received infigratinib as early-line therapy for mUC due to ineligibility to receive platinum-based chemotherapy. Overall, ORR was 25.4% (95% CI 15.5-37.5) and DCR was 64.2% (95% CI 51.5-75.5). ORR was 30.8% (95% CI 9.1-61.4) with early-line infigratinib and 24.1% (95% CI 13.5-37.6) for ≥2 LOT. DCR was 46.2% (95% CI 19.2-74.9) for early-line and 68.5% (95% CI 54.4-80.5) for ≥2 LOT. PFS and OS appeared similar in both groups. Thirteen of 59 patients with a bladder primary tumor received early-line treatment with an ORR of 30.5% (95% CI 9.1-61.4), and 46 received ≥2 LOT with an ORR of 20.3% (95% CI 9.4-33.9); BOR was 38.5% (95% CI: 13.9-68.4%) and 42.6% (95% CI: 29.2-56.8%) in the early-line and salvage settings, respectively. Eight patients with upper tract urothelial carcinoma received salvage therapy (ORR, 50.0%; DCR, 100.0%). No significant differences in toxicities between LOT were observed. Conclusion: Infigratinib has notable activity in patients with mUC regardless of LOT. The findings support the evaluation of infigratinib across different settings in mUC. © 2021 |
| Keywords: | bladder cancer; safety; efficacy; fgfr inhibitors; line of therapy |
| Journal Title: | Clinical Genitourinary Cancer |
| Volume: | 20 |
| Issue: | 1 |
| ISSN: | 1558-7673 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2022-02-01 |
| Start Page: | 35 |
| End Page: | 42 |
| Language: | English |
| DOI: | 10.1016/j.clgc.2021.10.004 |
| PUBMED: | 34782263 |
| PROVIDER: | scopus |
| PMCID: | PMC9460895 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 March 2022 -- Source: Scopus |
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