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.
Resources from the same session
5031 - Sarcoidosis-Like Reaction Mimics Progression in patients treated with immune checkpoint inhibitors
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract
5650 - Tissue-based activation of mucosal-associated invariant T (MAIT) cells in combination ipilimumab and nivolumab checkpoint inhibitor (CI) colitis.
Presenter: Sarah Sasson
Session: Poster Display session 3
Resources:
Abstract
5944 - Significance of severe immune-related adverse effects (irAE) on patients with advanced tumors treated with immune checkpoint inhibitors being admitted for secondary toxicity: Clinical relevance and next steps
Presenter: Leyre Zubiri
Session: Poster Display session 3
Resources:
Abstract
5989 - Implementation of a dedicated immuno-oncology toxicity service reduces the acute impact of immune-related adverse events
Presenter: Anna Olsson-Brown
Session: Poster Display session 3
Resources:
Abstract
3267 - Cardiotoxic and pro-inflammatory effects induced by the association of immune checkpoint inhibitor Pembrolizumab and Trastuzumab in preclinical models
Presenter: Nicola Maurea
Session: Poster Display session 3
Resources:
Abstract
3417 - Interstitial lung disease associated with immune-checkpoint inhibitors in malignant diseases
Presenter: Akira Yamagata
Session: Poster Display session 3
Resources:
Abstract
2071 - A Phase 1 Study of Intraperitoneal MCY-M11 Anti-Mesothelin CAR for Women with Platinum Resistant High Grade Serous Adenocarcinoma of the Ovary, Primary Peritoneum, or Fallopian Tube, or Subjects with Peritoneal Mesothelioma with Recurrence after Prior Chemotherapy
Presenter: Christina Annunziata
Session: Poster Display session 3
Resources:
Abstract
4935 - Trial in progress: First-in-human study of a novel anti-NY-ESO-1–anti-CD3, TCR-based bispecific (IMCnyeso) as monotherapy in NY-ESO-1/LAGE-1A-positive advanced solid tumors (IMCnyeso-101)
Presenter: Juanita Lopez
Session: Poster Display session 3
Resources:
Abstract
5613 - Nimotuzumab-Cisplatin-Radiation versus Cisplatin-Radiation in HPV negative oropharyngeal cancer
Presenter: Kumar Prabhash
Session: Poster Display session 3
Resources:
Abstract
2576 - Interim analysis of a single arm phase 2 study of adjuvant nivolumab after salvage resection in head and neck squamous cell carcinoma patients previously treated with definitive therapy.
Presenter: Trisha Wise-draper
Session: Poster Display session 3
Resources:
Abstract