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Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-09-29T02:06:48Z | - |
dc.date.available | 2021-09-29T02:06:48Z | - |
dc.date.issued | 2021-09 | - |
dc.identifier.issn | 0169-5002 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184716 | - |
dc.description.abstract | Objectives: This first-in-human phase I study (NCT03179436) investigated anti-cytotoxic T-lymphocyte-associated protein 4 monoclonal antibody quavonlimab and anti-programmed death 1 monoclonal antibody pembrolizumab in patients with advanced solid tumors. The study was conducted in two parts: dose-escalation (part 1) and dose-confirmation (part 2). First-line treatment with quavonlimab + pembrolizumab conferred encouraging antitumor activity (objective response rate [ORR], 28%-40%) and was generally well tolerated (grade ≥ 3 treatment-related adverse events [TRAEs] were lowest with quavonlimab 25 mg every 6 weeks [Q6W] at 30% and highest with quavonlimab 75 mg Q3W at 57%) in non-small cell lung cancer. We present data from patients with extensive-stage small cell lung cancer (SCLC) receiving second-line or later therapy. Materials and methods: Patients with stage III/IV SCLC received quavonlimab 75 mg Q6W plus pembrolizumab 200 mg Q3W for ≤ 2 years. Primary endpoints were safety and tolerability; ORRs as assessed by blinded independent central review per Response Evaluation Criteria In Solid Tumorsv1.1 was a secondary endpoint. Progression-free survival (PFS), overall survival (OS), and the correlation of response with PD-L1 expression were exploratory endpoints. Results: Forty patients with extensive-stage SCLC received treatment; median follow-up was 13 months. Dose-limiting toxicity occurred in 4 patients (10%). TRAEs occurred in 80% of patients; grade 3 events occurred in 33% of patients and no grade 4/5 events were reported. Confirmed ORRs (95% CI) were 18% (7-33) among all patients, 7% (<1-34) for PD-L1-positive tumors (n = 14), and 19% (5-42) for PD-L1-negative tumors (n = 21). Response duration ranged from 2.9 to 19.1+ months. Median PFS was 2.0 months; 6-month PFS rate was 26%. Median OS was 11.0 months; 6-month OS rate was 66%. Conclusions: Encouraging antitumor activity was observed with quavonlimab + pembrolizumab in patients with extensive-stage SCLC; responses were observed in PD-L1-positive and PD-L1-negative tumors. The combination was tolerable with manageable toxicities. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier Scientific Publishers | - |
dc.relation.isPartOf | LUNG CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody quavonlimab in combination with pembrolizumab: Safety and efficacy from a phase I study in previously treated extensive-stage small cell lung cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Kiyotaka Yoh | - |
dc.contributor.googleauthor | Ruth Perets | - |
dc.contributor.googleauthor | Adnan Nagrial | - |
dc.contributor.googleauthor | David R Spigel | - |
dc.contributor.googleauthor | Martin Gutierrez | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Dusan Kotasek | - |
dc.contributor.googleauthor | Drew Rasco | - |
dc.contributor.googleauthor | Jiaxin Niu | - |
dc.contributor.googleauthor | Miyako Satouchi | - |
dc.contributor.googleauthor | Myung-Ju Ahn | - |
dc.contributor.googleauthor | Dae Ho Lee | - |
dc.contributor.googleauthor | Corinne Maurice-Dror | - |
dc.contributor.googleauthor | Shabana Siddiqi | - |
dc.contributor.googleauthor | Yixin Ren | - |
dc.contributor.googleauthor | Rachel A Altura | - |
dc.contributor.googleauthor | Jair Bar | - |
dc.identifier.doi | 10.1016/j.lungcan.2021.07.009 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02174 | - |
dc.identifier.eissn | 1872-8332 | - |
dc.identifier.pmid | 34371366 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0169500221004657 | - |
dc.subject.keyword | CTLA-4 antigen | - |
dc.subject.keyword | Drug therapy , combination | - |
dc.subject.keyword | Immunotherapy | - |
dc.subject.keyword | Lung neoplasms | - |
dc.subject.keyword | Programmed cell death 1 receptor | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 159 | - |
dc.citation.startPage | 162 | - |
dc.citation.endPage | 170 | - |
dc.identifier.bibliographicCitation | LUNG CANCER, Vol.159 : 162-170, 2021-09 | - |
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