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E-Poster Display

746P - EV-201: Long-term results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and PD-1/PD-L1 inhibitors

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Peter O'Donnell

Citation

Annals of Oncology (2020) 31 (suppl_4): S550-S550. 10.1016/annonc/annonc274

Authors

P. O'Donnell1, M.D. Galsky2, J.E. Rosenberg3, D.P. Petrylak4, A.V. Balar5, B.A. McGregor6, E. Heath7, E.Y. Yu8, D.I. Quinn9, N.M. Hahn10, M. Campbell11, S. Liang12, J. Steinberg13, Y. Loriot14

Author affiliations

  • 1 Medicine, University of Chicago, 60637 - Chicago/US
  • 2 Medicine, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, 10029 - New York City/US
  • 3 Medical Oncology, Memorial Sloan Kettering Cancer Center, 10065 - New York City/US
  • 4 Department Of Urology, Yale University School of Medicine, 06519 - New Haven/US
  • 5 Medicine, Perlmutter Cancer Center at NYU Langone Health, 10016 - New York/US
  • 6 Lank Center For Gu Oncology, Dana Farber Cancer Institute, 02942 - Boston/US
  • 7 Oncology And Medicine, Karmanos Cancer Institute/Wayne State University, 48201 - Detroit/US
  • 8 Medicine, University of Washington, 98109 - Seattle/US
  • 9 Translation And Clinical Science Program / Oncology, University of Southern California, 90033 - Los Angeles/US
  • 10 Oncology And Urology, Greenberg Bladder Cancer Institute, Johns Hopkins University School of Medicine, 21287 - Baltimore/US
  • 11 Clinical Development, Seattle Genetics, Inc., 98021 - Bothell/US
  • 12 Biostatistics, Seattle Genetics, Inc., 98021 - Bothell/US
  • 13 Astellas Pharma Global Development, Astellas Pharma, Inc., 60062 - Northbrook/US
  • 14 Cancer Medicine Department, Institut de Cancerologie Gustave Roussy, 94805 - Villejuif/FR
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Abstract 746P

Background

Locally advanced or metastatic urothelial carcinoma (la/mUC) is an incurable disease with poor overall survival (OS), particularly in patients (pts) who progress on or after platinum-containing chemotherapy (Pt-CC). While OS data following PD-1/PD-L1 inhibitor (i) and Pt-CC are limited, data in earlier lines (post-Pt-CC) show a 7.4 mo median (md) OS with a 30.7% 12 mo OS rate for taxanes/vinflunine (Bellmunt 2017). In Dec 2019, enfortumab vedotin (EV), a Nectin-4 directed antibody-drug conjugate comprised of a fully human monoclonal antibody linked to the microtubule-disrupting agent monomethyl auristatin E was granted accelerated approval in adult pts with la/mUC who previously received PD-1/PD-L1-i and Pt-CC in the neoadjuvant/adjuvant, la/m setting. Approval was based on data as of 01 Mar 2019 from EV-201 (NCT03219333) Cohort 1 (C1) showing an ORR of 44% and a manageable side effect profile. We present data on C1 OS and safety with an additional year of follow-up (fu).

Methods

Pts in this open-label, multicenter study received EV 1.25 mg/kg on Days 1, 8, 15 of each 28-day cycle. The primary endpoint was confirmed ORR per RECIST 1.1 by BICR. Key secondary endpoints were OS, safety/tolerability, duration of response, and PFS.

Results

125 pts received EV in C1 (md age 69 y; md 3 prior systemic therapies; 35% upper tract disease; 40% liver metastases). Md fu was 22.3 mo (range, 0.5-27.3+) and md OS was 12.4 mo (95% CI: 9.46, 15.57). OS rates at 12 and 18 mo were 50.4% and 34.2%, respectively. Md and maximum treatment (tx) duration were 4.6 mo and 27.3 mo (ongoing as of data cutoff), respectively. The most common tx-related AEs included alopecia (49.6%), fatigue (49.6%), and decreased appetite (44%). Tx-related AEs of interest included any skin reactions (51.2% all grade [AG], 12.8% ≥ G3), any peripheral neuropathy (50.4% AG, 3.2% ≥ G3), and any hyperglycemia (11.2% AG, 5.6% ≥ G3).

Conclusions

OS from long-term fu of la/mUC pts who previously received PD-1/PD-L1-i and Pt-CC in EV-201 C1 is encouraging, with half of the pts alive at 12 mo and one-third alive at 18 mo; the safety of EV continues to be manageable in these pts with no new signals.

Clinical trial identification

NCT03219333.

Editorial acknowledgement

Medical writing assistance was funded by Seattle Genetics, Inc., and provided by Andrea Gwosdow, Ph.D. of Biobridges.

Legal entity responsible for the study

Seattle Genetics and Astellas Pharma, Inc.

Funding

Seattle Genetics and Astellas Pharma, Inc.

Disclosure

P. O'Donnell: Honoraria (institution): Astellas; Honoraria (institution), Research grant/Funding (institution): AstraZeneca; Honoraria (institution), Research grant/Funding (institution): Genentech; Honoraria (institution): Harrison Consulting Group; Honoraria (institution): Inovio; Honoraria (institution), Research grant/Funding (institution): Janssen; Honoraria (institution): Kantar Health; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): Merck; Honoraria (institution): OncLive; Honoraria (institution): Parexel; Honoraria (institution): Quintiles; Honoraria (institution), Research grant/Funding (institution): SeaGen; Research grant/Funding (institution): Acerta; Research grant/Funding (institution): B-M Squibb; Shareholder/Stockholder/Stock options: Allergan; Shareholder/Stockholder/Stock options: PrescriptlQ. M.D. Galsky: Advisory/Consultancy: Aileron Therapeutics; Advisory/Consultancy: Astellas; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: BioMotiv; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Dendreon; Advisory/Consultancy: Dracen; Advisory/Consultancy: EMD Serono; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Incyte; Advisory/Consultancy: Inovio Pharma; Advisory/Consultancy, Research grant/Funding (institution): Janssen; Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy: NuMab; Advisory/Consultancy: Pfizer; Advisory/Consultancy: SeaGen; Shareholder/Stockholder/Stock options: Rappta Therapeutics; Licensing/Royalties, July 2012 Application Number 20120322792: Mount Sinai School of Medicine. J.E. Rosenberg: Honoraria (self), Travel/Accommodation/Expenses: Chugai; Advisory/Consultancy: Adicet Bio; Advisory/Consultancy: Agensys; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: BioClin Therapeutics; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: Fortress Biotech; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Inovio Pharma; Advisory/Consultancy: Janssen; Advisory/Consultancy: Lilly; Advisory/Consultancy: Merck; Advisory/Consultancy: Pharmacyclics; Advisory/Consultancy, Research grant/Funding (institution): QED Therapeutics; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche/Genentech; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy: Sensei Biotherapeutics; Advisory/Consultancy: Western Oncolytics; Advisory/Consultancy: Boerhinger Ingelheim; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MedImmune; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Jounce Therapeutics; Research grant/Funding (institution): Mirati Therapeutics; Research grant/Funding (institution): Novartis; Licensing/Royalties: Predictor of Platinum Sensitivity. D.P. Petrylak: Advisory/Consultancy, Research grant/Funding (institution): Ada Cap (Advanced Accelerator Applications); Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Agensys Inc; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Bicycle Therapeutics; Advisory/Consultancy: Boehringer Ingelheim; Research grant/Funding (institution): BioXcel Therapeutics; Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Clovis Oncology; Research grant/Funding (institution): Eisai; Advisory/Consultancy, Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy: Exelixis; Research grant/Funding (institution): Endocyte; Advisory/Consultancy: Incyte; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Innocrin; Advisory/Consultancy: Janssen; Research grant/Funding (institution): MedImmune; Research grant/Funding (institution): Medivation; Advisory/Consultancy, Research grant/Funding (institution): Mirati; Advisory/Consultancy: Monopteros; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Pharmacyclics; Research grant/Funding (institution): Progenics; Research grant/Funding (institution): Replimune; Advisory/Consultancy, Research grant/Funding (institution): Roche; Research grant/Funding (institution): Sanofi Aventis; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy: Urogen; Shareholder/Stockholder/Stock options: Bellicum; Shareholder/Stockholder/Stock options: Tyme . A.V. Balar: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca/Medimmune; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Genentech/Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy: Cerulean Pharma; Advisory/Consultancy: Incyte; Advisory/Consultancy: Nektar; Advisory/Consultancy: Pfizer/EMD Serano; Advisory/Consultancy, Research grant/Funding (institution): Seattle Genetics; Shareholder/Stockholder/Stock options: Epivax Oncology. B.A. McGregor: Advisory/Consultancy: Astelleas; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Bayer; Advisory/Consultancy, Research grant/Funding (institution): Exelixis; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy: Janssen; Advisory/Consultancy: Nextar; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Research grant/Funding (institution): SeaGen; Advisory/Consultancy: EMD.Eisai; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Calithera Biosciences. E. Heath: Honoraria (institution): Bayer; Honoraria (institution): Dendreon; Honoraria (institution): Sanofi; Honoraria (institution), Research grant/Funding (institution): Seattle Genetics; Advisory/Consultancy: Agensys; Speaker Bureau/Expert testimony: Sanofi; Research grant/Funding (institution): Agensys; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Boehringer; Research grant/Funding (institution): B-M Squibb; Research grant/Funding (institution): Caris; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Celldex; Research grant/Funding (institution): Corcept; Research grant/Funding (institution): Curemeta; Research grant/Funding (institution): Dendreon; Research grant/Funding (institution): eFFECTOR Thera; Research grant/Funding (institution): Esanik; Research grant/Funding (institution): Fortis; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Inovio Pharma; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Millennium; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): Oncolys; Research grant/Funding (institution): Plexxikon; Research grant/Funding (institution): Synta; Research grant/Funding (institution): Tokai Pharma; Research grant/Funding (institution): Zenith Epigenetics. E.Y. Yu: Advisory/Consultancy: Abbvie; Advisory/Consultancy: Advanced Accelerator Applications; Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Clovis; Advisory/Consultancy: Dendreon; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: Incyte; Advisory/Consultancy: Janssen; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy: QED Therapeutics; Advisory/Consultancy: Sanofi-Genzyme; Advisory/Consultancy, Research grant/Funding (institution): SeaGen; Advisory/Consultancy: Tolmar; Research grant/Funding (institution): Daiichi-Sankyo; Research grant/Funding (institution): Dendreon; Research grant/Funding (institution): Pharmacyclics; Research grant/Funding (institution): Taiho. D.I. Quinn: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Astellas; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Genentech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Seattle Genetics; Full/Part-time employment: USC. N.M. Hahn: Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy: Health Advances; Advisory/Consultancy: Inovio Pharma; Advisory/Consultancy, Research grant/Funding (institution): Merck; Advisory/Consultancy, Research grant/Funding (institution): Oncogenex; Advisory/Consultancy: Pieris Pharma; Research grant/Funding (institution): Acerta Pharma; Research grant/Funding (institution): Heat Biologics; Research grant/Funding (institution): Mirati Therapeutics; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Principa Biopharma. M. Campbell: Shareholder/Stockholder/Stock options, Full/Part-time employment: Seattle Genetics, Inc. S-Y. Liang: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Seattle Genetics. J. Steinberg: Travel/Accommodation/Expenses, Full/Part-time employment: Astellas Pharma. Y. Loriot: Honoraria (institution), Research grant/Funding (institution): Roche; Honoraria (institution), Research grant/Funding (institution): Astellas; Honoraria (institution), Research grant/Funding (institution): Janssen; Honoraria (institution), Research grant/Funding (institution): Seattle Genetics; Honoraria (institution), Research grant/Funding (institution): AstraZeneca; Honoraria (institution), Research grant/Funding (institution): BMS; Honoraria (institution), Research grant/Funding (institution): MSD; Honoraria (institution), Research grant/Funding (institution): Pfizer; Honoraria (institution), Research grant/Funding (institution): Sanofi; Honoraria (institution): Ipsen; Research grant/Funding (institution): Clouis; Research grant/Funding (institution): Incyte.

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