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Conference/Presentation Title: | PIVOT-10: A phase II study of bempegaldesleukin (NKTR-214) in combination with nivolumab (NIVO) in cisplatin (cis) ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (mUC). | Authors: | Lin W.;Li P.-C.;Tagliaferri M.C.;Tagliaferri M.A.;Loriot Y.;Huddart R.A.;Siefker-Radtke A.O.;Balar A.V.;Bilen M.A.;Powles T.;Bamias A.;Castellano D.;Khalil M.F.;Van Der Heijden M.S.;Koshkin V.S.;Pook D.W.;Ozguroglu M.;Santiago L.;Saab R. | Monash Health Department(s): | Haematology Oncology |
Institution: | (Huddart, Siefker-Radtke, Balar, Bilen, Powles, Bamias, Castellano, Khalil, Van Der Heijden, Koshkin, Pook, Ozguroglu, Santiago, Saab, Li, Tagliaferri, Lin, Tagliaferri, Loriot) The Royal Marsden NHS Foundation Trust, Surrey, United Kingdom; The University of Texas MD Anderson Cancer Center, Houston, TX; Perlmutter Cancer Center at NYU Langone Health, New York, NY; Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA; Barts Cancer Institute, Queen Mary University of London, Royal Free NHS Trust, London, United Kingdom; Haematology-Oncology Unit, Department of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, Athens, Greece; Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; Lehigh Valley Hosp Network, Allentown, PA; Department of Medical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; University of California San Francisco, San Francisco, CA; Department of Medical Oncology, Monash Health, Melbourne, VIC, Australia; Cerrahpasa School of Medicine, Istanbul University-Cerrahpasa, Istanbul, Turkey; Nektar Therapeutics, San Francisco, CA; Institute Gustave Roussy, Universite Paris-Sud, Universite Paris-Saclay, Villejuif, France | Presentation/Conference Date: | 16-Mar-2020 | Copyright year: | 2020 | Publisher: | American Society of Clinical Oncology | Publication information: | Journal of Clinical Oncology. Conference: 2020 Genitourinary Cancers Symposium. San Francisco, CA United States. 38 (6 Supplement) (no pagination), 2020. Date of Publication: 2020. | Journal: | Journal of Clinical Oncology | Abstract: | Background: Checkpoint inhibitors can achieve durable responses in cis-ineligible 1L mUC. However, use is restricted to patients whose tumors are PD-L1 high. Approximately 70% of cis-ineligible patients have tumors with low PD-L1 expression, leaving a significant proportion of 1L mUC patients in need of new treatment options. Bempegaldesleukin (BEMPEG; NKTR-214) is a CD122-preferential IL-2 pathway agonist designed to provide sustained signaling through the IL-2 sy receptor. NIVO is an anti-PD-1 antibody that is approved for treatment in several types of cancers, including 2L mUC after treatment with a platinum agent. Early BEMPEG plus NIVO data in 1L mUC (cis-eligible and -ineligible) patients found an objective response rate (ORR) of 48% (13/27) in the efficacy evaluable population (defined as having undergone at least one post-baseline scan) and a CR rate of 19%, prompting this further exploration of BEMPEG plus NIVO in a phase 2 study (Siefker-Radke, 2019). Method(s): This Phase 2 multi-national trial evaluates BEMPEG plus NIVO in previously untreated patients with cis-ineligible mUC. Eligibility also requires tumor tissue be analyzed by central laboratory to document PD-L1 status. Approximately 205 patients will be enrolled. BEMPEG (0.006 mg/kg) and NIVO (360 mg) are given intravenously (IV) on Day 1 of each 3-week cycle. The primary endpoint is ORR assessed per RECIST 1.1 by blinded independent central review (BICR) in patients with low PD-L1 expression (defined as Combined Positive Score [CPS] < 10). Secondary endpoints include ORR and duration of response in all treated patients, safety, and tolerability. Tumor and blood samples will be collected for biomarker analyses. Enrollment is ongoing. | Conference Start Date: | 2020-02-27 | Conference End Date: | 2020-02-29 | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1200/JCO.2020.38.6_suppl.TPS589 | ISSN: | 1527-7755 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/35140 | Type: | Conference Abstract | Subjects: | drug efficacy drug safety gene expression phase 2 protein expression response evaluation criteria in solid tumors signal transduction bempegaldesleukin biological marker cisplatin interleukin 2 interleukin 2 receptor beta nivolumab programmed 1 ligand 1 programmed 1 receptor advanced cancer bladder metastasis |
Type of Clinical Study or Trial: | Clinical trial |
Appears in Collections: | Conferences |
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