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Poster Display session 3

4840 - Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients (pts) with metastatic urothelial carcinoma (mUC)

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Urothelial Cancer

Presenters

Arlene Siefker-Radtke

Citation

Annals of Oncology (2019) 30 (suppl_5): v356-v402. 10.1093/annonc/mdz249

Authors

A.O. Siefker-Radtke1, B. Zhong2, K. Qi3, W.S. Shalaby4, P. De Porre5, A. O'Hagan6, P. Mahadevia7, Y. Loriot8

Author affiliations

  • 1 Genitourinary Medical Oncology, The M. D. Anderson Cancer Center, 77030-3721 - Houston/US
  • 2 Clinical Biostatistics, Janssen Research & Development, LLC, 19477 - Spring House/US
  • 3 Statistics And Data Science, Janssen Research & Development, LLC, Titusville/US
  • 4 Medical Oncology, Janssen Research & Development, LLC, 19044 - Horsham/US
  • 5 Clinical Oncology, Janssen EMEA Belgium, 2340 - Beerse/BE
  • 6 Clinical Oncology, Janssen Research & development, 19477 - Spring House/US
  • 7 Global Medical Affairs, Janssen Pharmaceuticals, NJ 08869 - Raritan/US
  • 8 Department Of Cancer Medicine, Gustave Roussy, 94805 - Villejuif/FR

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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 therapyMedian TTP (95% CI), monthsORR (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-eligible8.84 (6.37; 10.38)18/52 (34.6)31/52 (59.6)
C-ineligible6.59 (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/P7.13 (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/P5.55 (2.99; 9.46)1/7 (14.3)3/7 (42.9)
Therapy after erda (n = 34)ORR (%)DCR (%)
1st-line after erda1/34 (2.9)3/34 (8.8)
1st-line chemotherapy0/160/16
1st-line immunotherapy1/15 (6.7)3/15 (20.0)
2nd-line after erda1/9 (11.1)1/9 (11.1)
2nd-line chemotherapy0/70/7
2nd-line immunotherapy1/2 (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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