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23 results on '"Balar, A.V."'

1. TROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes

Author

Loriot, Y., Petrylak, D.P., Rezazadeh Kalebasty, A., Fléchon, A., Jain, R.K., Gupta, S., Bupathi, M., Beuzeboc, P., Palmbos, P., Balar, A.V., Kyriakopoulos, C.E., Pouessel, D., Sternberg, C.N., Tonelli, J., Sierecki, M., Zhou, H., Grivas, P., Barthélémy, P., and Tagawa, S.T.

Published
2024
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2. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up

Author

Balar, A.V., primary, Castellano, D.E., additional, Grivas, P., additional, Vaughn, D.J., additional, Powles, T., additional, Vuky, J., additional, Fradet, Y., additional, Lee, J.-L., additional, Fong, L., additional, Vogelzang, N.J., additional, Climent, M.A., additional, Necchi, A., additional, Petrylak, D.P., additional, Plimack, E.R., additional, Xu, J.Z., additional, Imai, K., additional, Moreno, B.H., additional, Bellmunt, J., additional, de Wit, R., additional, and O’Donnell, P.H., additional

Published
2023
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4. 1423TiP CYCLONE 3: A phase III, randomized, double-blind, placebo-controlled study of abemaciclib in combination with abiraterone plus prednisone in men with high-risk metastatic hormone-sensitive prostate cancer (mHSPC)

Author

McKay, R.R., primary, Agarwal, N., additional, Matsubara, N., additional, Piulats Rodriguez, J.M., additional, Smith, M.R., additional, Todenhöfer, T., additional, Zhang, T., additional, Balar, A.V., additional, Schaverien, C., additional, Sherwood, S., additional, Johnston, E., additional, Lithio, A., additional, Nacerddine, K., additional, and Sweeney, C.J., additional

Published
2022
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5. 83P Evaluation of concordance between PD-L1 immunohistochemistry 28-8 and 22C3 pharmDx assays in metastatic urothelial carcinoma (mUC) in PIVOT-10

Author

Siefker-Radtke, A.O., primary, Hoch, U., additional, Loriot, Y., additional, Balar, A.V., additional, Bilen, M.A., additional, Tannir, N.M., additional, Cho, D.C., additional, Choudhury, A., additional, Chien, D., additional, Yu, D., additional, Currie, S.L., additional, Novotny, J., additional, Santiago, L., additional, Tagliaferri, M.A., additional, Zalevsky, J., additional, and Huddart, R.A., additional

Published
2021
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6. 700P Efficacy of sacituzumab govitecan (SG) by trophoblast cell surface antigen 2 (Trop-2) expression in patients (Pts) with metastatic urothelial cancer (mUC)

Author

Loriot, Y., primary, Balar, A.V., additional, Petrylak, D.P., additional, Rezazadeh, A., additional, Grivas, P., additional, Fléchon, A., additional, Jain, R.K., additional, Agarwal, N., additional, Bupathi, M., additional, Barthelemy, P., additional, Beuzeboc, P., additional, Palmbos, P., additional, Kyriakopoulos, C., additional, Pouessel, D., additional, Sternberg, C.N., additional, Pan, Y., additional, Jürgensmeier, J.M., additional, Goswami, T., additional, and Tagawa, S.T., additional

Published
2021
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7. 699P Atezolizumab monotherapy in cisplatin-ineligible patients with previously untreated metastatic urothelial carcinoma: 5-year response and survival analysis from the phase II IMvigor210 study (cohort 1)

Author

Rosenberg, J.E., primary, Galsky, M.D., additional, Balar, A.V., additional, Loriot, Y., additional, Necchi, A., additional, Hoffman-Censits, J., additional, Srinivas, S., additional, Drakaki, A., additional, Javery, A., additional, Nelson, B., additional, Huang, H.X., additional, Shen, X., additional, and van der Heijden, M.S., additional

Published
2021
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8. PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer

Author

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. Zhong, B. Chien, D. Lin, W. Tagliaferri, M.A. Loriot, Y.

Abstract

The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response). © 2020 Robert A Huddart and co-authors.

Published
2021

9. PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer.

Author

Castellano D., Van Der Heijden M.S., Koshkin V.S., Pook D.W., Ozguroglu M., Santiago L., Zhong B., Chien D., Lin W., Tagliaferri M.A., Loriot Y., Khalil M.F., Huddart R.A., Siefker-Radtke A.O., Balar A.V., Bilen M.A., Powles T., Bamias A., Castellano D., Van Der Heijden M.S., Koshkin V.S., Pook D.W., Ozguroglu M., Santiago L., Zhong B., Chien D., Lin W., Tagliaferri M.A., Loriot Y., Khalil M.F., Huddart R.A., Siefker-Radtke A.O., Balar A.V., Bilen M.A., Powles T., and Bamias A.

Abstract

The choice of first-line therapy for patients with metastatic urothelial cancer (mUC) is based on cisplatin-eligibility and programmed death-ligand 1 (PD-L1) status. For patients with mUC who are ineligible for cisplatin and with low PD-L1 expression, chemotherapy-based regimens are the only approved first-line option. In a Phase I/II trial of the chemotherapy-free regimen, bempegaldesleukin (BEMPEG; NKTR-214) plus nivolumab, patients with locally advanced or mUC experienced tumor responses regardless of baseline PD-L1 expression (objective response rates: 50 and 45% in patients with PD-L1-positive and-negative tumors, respectively). The Phase II PIVOT-10 study (NCT03785925), evaluates efficacy and safety of first-line BEMPEG plus nivolumab in cisplatin-ineligible patients with locally advanced or mUC. Most patients will have low PD-L1 expression. Primary end point: objective response rates (including complete response).Copyright © 2020 Robert A Huddart and co-authors.

Published
2021

10. 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).

Author

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., 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., and Saab R.

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.

Published
2020

11. Pembrolizumab as First-line Therapy in Cisplatin-ineligible Advanced Urothelial Cancer (KEYNOTE-052): Outcomes in Older Patients by Age and Performance Status

Author

Grivas, P., Plimack, E.R., Balar, A.V., Castellano, D, O'Donnell, P.H., Bellmunt, J. (Joaquim), Powles, T. (Tom), Hahn, N.M., Wit, R. (Ronald) de, Bajorin, D.F., Ellison, M.C., Frenkl, T.L., Godwin, J.L., Vuky, J., Grivas, P., Plimack, E.R., Balar, A.V., Castellano, D, O'Donnell, P.H., Bellmunt, J. (Joaquim), Powles, T. (Tom), Hahn, N.M., Wit, R. (Ronald) de, Bajorin, D.F., Ellison, M.C., Frenkl, T.L., Godwin, J.L., and Vuky, J.

Abstract

Background: Patients with treatment-naive advanced urothelial cancer (UC) ineligible for cisplatin-based chemotherapy are typically older and have comorbidities, representing a difficult-to-treat population. Objective: To evaluate the safety and antitumor activity of first-line pembrolizumab in subgroups of cisplatin-ineligible older patients (aged 65 and 75 yr) with advanced UC in KEYNOTE-052 (NCT02335424), including those with poor performance status (Eastern Cooperative Oncology Group performance status score 2 [ECOG PS2]). Design, setting, and participants: Patients were cisplatin ineligible, had treatmentnaive, histologically/cytologically confirmed, locally advanced/metastatic UC with measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]), and had ECOG PS0–2. Patient subgroups analyzed were aged 65 yr (n = 302), 75 yr (n = 179), 65 yr with ECOG PS2 (65 yr + ECOG PS2; n = 119), and 75 yr + ECOG PS2 (n = 78). Intervention: All patients received pembrolizumab 200 mg intravenously every 3 wk until confirmed progression, intolerable toxicity, patient withdrawal, or 24 mo of therapy. Outcome measurements and statistical analysis: The primary endpoint was objective response rate (ORR) as per RECIST v1.1. The key secondary endpoints were overall survival (OS), duration of response (DOR), and safety. Results and limitations: ORRs for the 65 yr, 75 yr, 65 yr + ECOG PS2, and 75 yr + ECOG PS2 subgroups were 29%, 27%, 29%, and 31%, respectively; rates of complete and partial responses were similar across subgroups (9%, 5%, 6%, and 6%, and 20%, 22%, 23%, and 24%, respectively). Median DOR and OS were also consistent across the 65 yr and 65 yr + ECOG PS2 subgroups and the 75 yr and 75 yr + ECOG PS2 subgroups. Study limitations included open-label design, lack of a comparator group, and nature of post hoc exploratory analysis.

Published
2020
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13. 596TiP Phase I first-in-human study of ABBV-151 as monotherapy or in combination with budigalimab in patients with locally advanced or metastatic solid tumours

Author

Powderly, J., primary, Shimizu, T., additional, Lorusso, P., additional, Razak, A., additional, Miller, K.D., additional, Balar, A.V., additional, Bruix, J., additional, Michel, L.S., additional, Blaney, M., additional, Guan, X., additional, Lacy, S., additional, Lally, S., additional, Lambert, S., additional, Leibman, R., additional, Vosganian, G., additional, Golan, T., additional, and Tolcher, A., additional

Published
2020
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14. 744P Association between gene expression signatures (sigs) and pembrolizumab (pembro) efficacy in patients (pts) with advanced urothelial cancer (UC)

Author

Grivas, P., primary, Balar, A.V., additional, Vuky, J., additional, de Wit, R., additional, Vogelzang, N.J., additional, Choueiri, T.K., additional, Bajorin, D., additional, Castellano Gauna, D., additional, Gerritsen, W., additional, Gurney, H., additional, Quinn, D.I., additional, Culine, S., additional, Fradet, Y., additional, Saadatpour, A., additional, Loboda, A., additional, Ma, J., additional, Rajasagi, M., additional, Godwin, J.L., additional, Moreno, B.H., additional, and Bellmunt, J., additional

Published
2020
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15. 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

Author

O'Donnell, P., primary, Galsky, M.D., additional, Rosenberg, J.E., additional, Petrylak, D.P., additional, Balar, A.V., additional, McGregor, B.A., additional, Heath, E., additional, Yu, E.Y., additional, Quinn, D.I., additional, Hahn, N.M., additional, Campbell, M., additional, Liang, S-Y., additional, Steinberg, J., additional, and Loriot, Y., additional

Published
2020
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16. LBA24 TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI)

Author

Loriot, Y., primary, Balar, A.V., additional, Petrylak, D.P., additional, Tagawa, S.T., additional, Rezazadeh, A., additional, Fléchon, A., additional, Jain, R., additional, Agarwal, N., additional, Bupathi, M., additional, Barthélémy, P., additional, Beuzeboc, P., additional, Palmbos, P.L., additional, Kyriakopoulos, C.E., additional, Pouessel, D., additional, Sternberg, C.N., additional, Hong, Q., additional, Goswami, T., additional, Itri, L.M., additional, and Grivas, P., additional

Published
2020
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17. Updated follow-up from KEYNOTE-057: Phase 2 study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non–muscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guérin (BCG)

Author

Boormans, J.L., primary, De Wit, R., additional, Kulkarni, G.S., additional, Uchio, E.M., additional, Roumiguié, M., additional, Krieger, L.E.M., additional, Singer, E.A., additional, Bajorin, D.F., additional, Kamat, A.M., additional, Grivas, P., additional, Seo, H.K., additional, Nishiyama, H., additional, Konethy, B.R., additional, Saretsky, T., additional, Li, H., additional, Nam, K., additional, Kapadia, E., additional, and Balar, A.V., additional

Published
2020
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18. Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG)

Author

de Wit, R., primary, Kulkarni, G.S., additional, Uchio, E., additional, Boormans, J.L., additional, Roumiguié, M., additional, Krieger, L.E.M., additional, Singer, E.A., additional, Bajorin, D.F., additional, Kamat, A.M., additional, Grivas, P., additional, Seo, H.K., additional, Nishiyama, H., additional, Konety, B.R., additional, Saretsky, T., additional, Li, H., additional, Nam, K., additional, Sbar, E., additional, and Balar, A.V., additional

Published
2019
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19. Pembrolizumab for patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guérin: The phase 2 KEYNOTE-057 study

Author

Boormans, J.L., primary, Balar, A.V., additional, De Wit, R., additional, Kamat, A., additional, Uchio, E., additional, Mourey, L., additional, Krieger, L., additional, Singer, E.A., additional, Bajorin, D., additional, Grivas, P., additional, Seo, H.K., additional, Nishiyama, H., additional, Konety, B., additional, Nam, K., additional, Kapadia, E., additional, Frenkl, T., additional, and Kulkarini, G.S., additional

Published
2019
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20. Pembrolizumab (pembro) as first-line therapy in cisplatin-ineligible advanced urothelial cancer (UC): Outcomes from KEYNOTE-052 in senior patients (pts) with poor performance status

Author

Grivas, P., primary, Plimack, E., additional, Balar, A.V., additional, Castellano, D., additional, O'Donnell, P.H., additional, Bellmunt, J., additional, Powles, T., additional, Hahn, N., additional, de Wit, R., additional, Bajorin, D., additional, Ellison, M.C., additional, Frenkl, T., additional, Keefe, S.M., additional, and Vuky, J., additional

Published
2017
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21. 916P - Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG)

Author

de Wit, R., Kulkarni, G.S., Uchio, E., Boormans, J.L., Roumiguié, M., Krieger, L.E.M., Singer, E.A., Bajorin, D.F., Kamat, A.M., Grivas, P., Seo, H.K., Nishiyama, H., Konety, B.R., Saretsky, T., Li, H., Nam, K., Sbar, E., and Balar, A.V.

Published
2019
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