Abstract 4840
Background
Recently, erdafitinib (erda), a novel FGFR-targeted therapy received accelerated US FDA approval for locally-advanced or mUC in adult pts with FGFR2/3 alterations who progressed on prior 1st-line platinum-containing chemotherapy. The current analysis was performed to understand treatment response to prior and subsequent therapies in FGFR+ mUC pts treated with erda.
Methods
Pts with surgically unresectable mUC who had failed ≥1 prior chemotherapy and received 8 mg once-daily erda in a phase 2 study (NCT02365597) were retrospectively assessed. Pts were grouped as cisplatin (C)-eligible (received 1st-line gemcitabine [G]-C or MVAC [methotrexate/vinblastine/doxorubicin/C]) or C-ineligible (received 1st-line G-carboplatin or checkpoint inhibitors). Treatment duration, time to progression (TTP) and response to prior chemotherapy (objective response rate [ORR] and disease control rate [DCR]), progression-free survival (PFS), overall survival (OS), and subsequent response after erda therapy were assessed using investigator reported outcomes.
Results
In this analysis, the median duration of treatment (time from 1st dose of 1st line to 1st dose of 2nd line) with 1st-line chemotherapy was 10.07 months for C-eligible (n = 52) and 8.02 months for C-ineligible (n = 34) pts; 31 pts received prior 2nd-line chemotherapy (median treatment duration: 9.23 months) and 10 received 3rd-line chemotherapy (median treatment duration: 6.26 months). The median TPP for prior 1st-line therapy was longer than on 2nd or 3rd-line therapy (Table). In total, 34 patients received treatment (chemotherapy, n = 19; immunotherapy, n = 15) after erda and had median PFS of 2.27 months (95% CI: 0.79; 2.86) and median OS of 3.52 months (95% CI: 2.04; 8.90).Table:
925P Efficacy results on prior and subsequent treatments
Prior therapy | Median TTP (95% CI), months | ORR (CR+PR) (%) | DCR (CR+PR+ SD) (%) |
---|---|---|---|
1st-line chemotherapy (n = 84) | 7.34 (5.91; 8.80) | 28/84 (33.3) | 49/84 (58.3) |
C-eligible | 8.84 (6.37; 10.38) | 18/52 (34.6) | 31/52 (59.6) |
C-ineligible | 6.59 (3.06; 7.49) | 9/34 (26.5) | 18/34 (52.9) |
2nd-line chemotherapy (n = 31) | 7.13 (3.78; 9.36) | 11/31 (35.5) | 21/31 (67.7) |
2nd-line D/V/P | 7.13 (3.06; 10.48) | 6/16 (37.5) | 10/16 (62.5) |
3rd-line chemotherapy (n = 10) | 5.70 (2.33; 8.64) | 2/10 (20.0) | 5/10 (50.0) |
3rd-line D/V/P | 5.55 (2.99; 9.46) | 1/7 (14.3) | 3/7 (42.9) |
Therapy after erda (n = 34) | ORR (%) | DCR (%) | |
1st-line after erda | 1/34 (2.9) | 3/34 (8.8) | |
1st-line chemotherapy | 0/16 | 0/16 | |
1st-line immunotherapy | 1/15 (6.7) | 3/15 (20.0) | |
2nd-line after erda | 1/9 (11.1) | 1/9 (11.1) | |
2nd-line chemotherapy | 0/7 | 0/7 | |
2nd-line immunotherapy | 1/2 (50.0) | 1/2 (50.0) |
CR, complete response; D/V/P, docetaxel/vinflunine/paclitaxel; PR, partial response; SD, stable disease.
Conclusions
These results provide insights into treatment responses in a unique population of FGFR+ mUC pts.
Clinical trial identification
NCT02365597.
Editorial acknowledgement
Priya Ganpathy, MPharm, ISMPP CMPP™ (SIRO Clinpharm Pvt. Ltd., India) provided writing assistance and Harry Ma, PhD (Janssen Global Services, LLC) provided additional editorial support.
Legal entity responsible for the study
Janssen Research & Development, LLC.
Funding
Janssen Research & Development, LLC.
Disclosure
A.O. Siefker-Radtke: Advisory / Consultancy: Janssen, Threshold Pharmaceuticals, Merck, National Comprehensive Cancer Network, Eisai, Genentech, Vertex, AstraZeneca, EMD Serono, Bristol-Myers Squibb; Research grant / Funding (self): National Institutes of Health, Genentech, Janssen Pharmaceuticals, Millennium, Michael and Sherry Sutton Fund for Urothelial Cancer; Speaker Bureau / Expert testimony: Genentech. B. Zhong: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development. K. Qi: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development. W.S. Shalaby: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development. P. De Porre: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development. A. O’Hagan: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development, LLC. P. Mahadevia: Shareholder / Stockholder / Stock options, Employee and stockholder: Janssen Research & Development. Y. Loriot: Advisory / Consultancy: Astellas Oncology; AstraZeneca; Ipsen; Janssen; MSD; Roche; Sanofi; Research grant / Funding (self): Sanofi (Inst); Travel / Accommodation / Expenses: AstraZeneca; MSD; Roche.
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