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
5043 - Comprehensive results of a Phase Ib study with a HER2/neu B-cell peptide vaccine administered with cisplatin and 5-fluorouracil or capecitabine chemotherapy show safety, immunogenicity and clinical response in patients with HER2/Neu overexpressing advanced gastric cancer
Presenter: Ursula Wiedermann
Session: Poster Display session 3
Resources:
Abstract
4506 - Single intravenous preoperative administration of the oncolytic virus Pexa-Vec to prime anti-tumor immunity
Presenter: Adel Samson
Session: Poster Display session 3
Resources:
Abstract
1631 - Randomized phase 2 clinical trial of NY-ESO-1 protein vaccine combined with cholesteryl pullulan (CHP-NY-ESO-1) in resected esophageal cancer patients
Presenter: Shinichi Kageyama
Session: Poster Display session 3
Resources:
Abstract
4244 - T cell repertoire sequencing reveals dynamics of response to dendritic cell vaccine plus dasatinib for checkpoint blockade resistant metastatic melanoma
Presenter: Luca Quagliata
Session: Poster Display session 3
Resources:
Abstract
5791 - Ixovex, a novel oncolytic E1B-mutated adenovirus
Presenter: Mohiemen Anwar
Session: Poster Display session 3
Resources:
Abstract
4170 - Anti-CSPG4 DNA vaccination as a promising strategy for the treatment of CSPG4+ tumors: a comparative oncology trial
Presenter: Federica Riccardo
Session: Poster Display session 3
Resources:
Abstract
5780 - Antitumor activity, immunogenicity and safety of a novel PD-1 vaccine in combination with two chimeric HER-2 peptide vaccine in syngeneic Balb/c, C57Bl/6 models and in beagle dogs
Presenter: Pravin Kaumaya
Session: Poster Display session 3
Resources:
Abstract
5860 - Maternal immunization against ALK as a weapon to fight neuroblastoma
Presenter: Giuseppina Barutello
Session: Poster Display session 3
Resources:
Abstract
4720 - Phase 1 study evaluating safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-428, first-in-class mesothelin (MSLN)-CD40 bispecific, in patients (pts) with advanced solid tumors
Presenter: Jason Luke
Session: Poster Display session 3
Resources:
Abstract
5717 - Anti-PD-L1/IL-15 fusion protein generates robust adaptive immune gene signatures in tumors leading to tumor inhibition and memory responses
Presenter: Stella Martomo
Session: Poster Display session 3
Resources:
Abstract