Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study
Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evalu...
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| Vydáno v: | Journal of clinical oncology Ročník 40; číslo 7; s. 762 |
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| Médium: | Journal Article |
| Jazyk: | angličtina |
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01.03.2022
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| ISSN: | 1527-7755, 1527-7755 |
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| Abstract | Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy.
Patients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival.
In total, 155 women (median age, 50 years [range, 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1-positive and programmed death ligand-1-negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events.
Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte-associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing. |
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| AbstractList | Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy.
Patients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival.
In total, 155 women (median age, 50 years [range, 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1-positive and programmed death ligand-1-negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events.
Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte-associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing. Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy.PURPOSEBalstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy.Patients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival.PATIENTS AND METHODSPatients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival.In total, 155 women (median age, 50 years [range, 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1-positive and programmed death ligand-1-negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events.RESULTSIn total, 155 women (median age, 50 years [range, 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1-positive and programmed death ligand-1-negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events.Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte-associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing.CONCLUSIONPromising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte-associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing. |
| Author | Wang, Edward W Monk, Bradley J Kryzhanivska, Anna Bulat, Iurie O'Malley, David M Neffa, Maryna Ancukiewicz, Marek Melkadze, Tamar Meniawy, Tarek M Bagameri, Andrea Doger de Speville Uribe, Bernard Hegg, Roberto Ortuzar Feliu, Waldo Huang, Marilyn Lugowska, Iwona |
| Author_xml | – sequence: 1 givenname: David M orcidid: 0000-0002-2828-0177 surname: O'Malley fullname: O'Malley, David M organization: Division of Gynecologic Oncology, The Ohio State University/James Comprehensive Cancer Center, Columbus, OH – sequence: 2 givenname: Maryna surname: Neffa fullname: Neffa, Maryna organization: CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection, Kharvik, Ukraine – sequence: 3 givenname: Bradley J orcidid: 0000-0002-0680-3184 surname: Monk fullname: Monk, Bradley J organization: Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona, Creighton University, Phoenix, AZ – sequence: 4 givenname: Tamar orcidid: 0000-0003-0800-6514 surname: Melkadze fullname: Melkadze, Tamar organization: Research Institute of Clinical Medicine, Tbilisi, Georgia – sequence: 5 givenname: Marilyn surname: Huang fullname: Huang, Marilyn organization: Division of Gynecologic Oncology, University of Miami School of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL – sequence: 6 givenname: Anna orcidid: 0000-0001-7720-7374 surname: Kryzhanivska fullname: Kryzhanivska, Anna organization: Regional Clinical Oncology Center, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine – sequence: 7 givenname: Iurie surname: Bulat fullname: Bulat, Iurie organization: ARENSIA Exploratory Medicine Unit, Institute of Oncology, Chisinau, Moldova – sequence: 8 givenname: Tarek M orcidid: 0000-0002-1457-6137 surname: Meniawy fullname: Meniawy, Tarek M organization: Linear Clinical Research, Nedlands, Australia – sequence: 9 givenname: Andrea surname: Bagameri fullname: Bagameri, Andrea organization: Országos Onkológiai Intézet, Budapest, Hungary – sequence: 10 givenname: Edward W surname: Wang fullname: Wang, Edward W organization: Medical Oncology and Therapeutic Research, City of Hope Comprehensive Cancer Center, Duarte, CA – sequence: 11 givenname: Bernard surname: Doger de Speville Uribe fullname: Doger de Speville Uribe, Bernard organization: START Madrid FJD, Madrid, Spain – sequence: 12 givenname: Roberto surname: Hegg fullname: Hegg, Roberto organization: Clínica de Pesquisa e Centro de Estudos em Oncologia Ginecológica e Mamária, Sao Paulo, Brazil – sequence: 13 givenname: Waldo orcidid: 0000-0003-0339-9216 surname: Ortuzar Feliu fullname: Ortuzar Feliu, Waldo organization: Agenus Inc, Waltham, MA – sequence: 14 givenname: Marek surname: Ancukiewicz fullname: Ancukiewicz, Marek organization: Agenus Inc, Waltham, MA – sequence: 15 givenname: Iwona orcidid: 0000-0001-9511-178X surname: Lugowska fullname: Lugowska, Iwona organization: Maria Sklodowska-Curie National Research Unit of Oncology, Warsaw, Poland |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34932394$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use CTLA-4 Antigen - antagonists & inhibitors Female Follow-Up Studies Humans Immune Checkpoint Inhibitors - therapeutic use Middle Aged Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - immunology Neoplasm Recurrence, Local - pathology Prognosis Programmed Cell Death 1 Receptor - antagonists & inhibitors Survival Rate Uterine Cervical Neoplasms - drug therapy Uterine Cervical Neoplasms - immunology Uterine Cervical Neoplasms - pathology Young Adult |
| Title | Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study |
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