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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 | Cho, Byoung Chul | - |
dc.contributor.author | Yoh, Kiyotaka | - |
dc.contributor.author | Perets, Ruth | - |
dc.contributor.author | Nagrial, Adnan | - |
dc.contributor.author | Spigel, David R. | - |
dc.contributor.author | Gutierrez, Martin | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Kotasek, Dusan | - |
dc.contributor.author | Rasco, Drew | - |
dc.contributor.author | Niu, Jiaxin | - |
dc.contributor.author | Satouchi, Miyako | - |
dc.contributor.author | Ahn, Myung-Ju | - |
dc.contributor.author | Lee, Dae Ho | - |
dc.contributor.author | Maurice-Dror, Corinne | - |
dc.contributor.author | Siddiqi, Shabana | - |
dc.contributor.author | Ren, Yixin | - |
dc.contributor.author | Altura, Rachel A. | - |
dc.contributor.author | Bar, Jair | - |
dc.date.accessioned | 2022-04-20T10:28:02Z | - |
dc.date.available | 2022-04-20T10:28:02Z | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.created | 2021-08-30 | - |
dc.date.issued | 2021-09 | - |
dc.identifier.citation | Lung Cancer, Vol.159, pp.162-170 | - |
dc.identifier.issn | 0169-5002 | - |
dc.identifier.other | 140891 | - |
dc.identifier.uri | https://hdl.handle.net/10371/179099 | - |
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 Tumors v1.1 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.language | 영어 | - |
dc.publisher | Elsevier BV | - |
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.AlternativeAuthor | 김동완 | - |
dc.identifier.doi | 10.1016/j.lungcan.2021.07.009 | - |
dc.citation.journaltitle | Lung Cancer | - |
dc.identifier.wosid | 000685268300021 | - |
dc.identifier.scopusid | 2-s2.0-85111974489 | - |
dc.citation.endpage | 170 | - |
dc.citation.startpage | 162 | - |
dc.citation.volume | 159 | - |
dc.identifier.sci | 000685268300021 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | NIVOLUMAB PLUS IPILIMUMAB | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | 1ST-LINE TREATMENT | - |
dc.subject.keywordPlus | TREMELIMUMAB | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | DURVALUMAB | - |
dc.subject.keywordPlus | BLOCKADE | - |
dc.subject.keywordPlus | MK-1308 | - |
dc.subject.keywordAuthor | Lung neoplasms | - |
dc.subject.keywordAuthor | CTLA-4 antigen | - |
dc.subject.keywordAuthor | Programmed cell death 1 receptor | - |
dc.subject.keywordAuthor | Drug therapy | - |
dc.subject.keywordAuthor | combination | - |
dc.subject.keywordAuthor | Immunotherapy | - |
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