Publications
Detailed Information
Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Perets, R. | - |
dc.contributor.author | Bar, J. | - |
dc.contributor.author | Rasco, D. W. | - |
dc.contributor.author | Ahn, M-J | - |
dc.contributor.author | Yoh, K. | - |
dc.contributor.author | Kim, D-W | - |
dc.contributor.author | Nagrial, A. | - |
dc.contributor.author | Satouchi, M. | - |
dc.contributor.author | Lee, D. H. | - |
dc.contributor.author | Spigel, D. R. | - |
dc.contributor.author | Kotasek, D. | - |
dc.contributor.author | Gutierrez, M. | - |
dc.contributor.author | Niu, J. | - |
dc.contributor.author | Siddiqi, S. | - |
dc.contributor.author | Li, X. | - |
dc.contributor.author | Cyrus, J. | - |
dc.contributor.author | Chackerian, A. | - |
dc.contributor.author | Chain, A. | - |
dc.contributor.author | Altura, R. A. | - |
dc.contributor.author | Cho, B. C. | - |
dc.date.accessioned | 2023-03-21T00:37:20Z | - |
dc.date.available | 2023-03-21T00:37:20Z | - |
dc.date.created | 2021-06-04 | - |
dc.date.issued | 2021-03 | - |
dc.identifier.citation | Annals of Oncology, Vol.32 No.3, pp.395-403 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://hdl.handle.net/10371/189659 | - |
dc.description.abstract | Background: Quavonlimab (MK-1308), a novel anti-CTLA-4 antibody, in combination with pembrolizumab was investigated in a phase I study. Patients and methods: Dose-escalation (DE) phase: patients with advanced/metastatic solid tumors received an initial flat dose of quavonlimab as monotherapy [25 mg (cohort 1), 75 mg (cohort 2), or 200 mg (cohort 3)] followed by four treatments of the same quavonlimab dose plus pembrolizumab every 3 weeks (Q3W). Dose-confirmation phase (DC): patients with stage IIIB/IV non-small-cell lung cancer (NSCLC) received first-line quavonlimab [25 mg Q3W (arm A), 25 mg Q6W (arm B), 75 mg Q6W (arm C), or 75 mg Q3W (arm E)] plus pembrolizumab. Primary objectives were safety and tolerability and establishment of the recommended phase H dose (RP2D) of quavonlimab when used with pembrolizumab. Objective response rate (ORR) was a secondary endpoint. Efficacy based on PD-L1 expression, tumor mutational burden (TMB), and changes in circulating CD4+/CD8+ cells were exploratory endpoints. Results: Thirty-nine patients were enrolled in DE [n = 14 (cohort 1); n = 17 (cohort 2); n = 8 (cohort 3)] and 134 in DC [n = 40 (arm A); n = 40 (arm B); n = 40 (arm C); n = 14 (arm E)]. Maximum-tolerated dose was not reached. Grade 3-5 treatment-related adverse events (AEs; graded according to NCI CTCAE v4.03) occurred in 0%, 23.5%, and 75.0% of patients in DE cohorts 1, 2, and 3, respectively, and 35.0%, 30.0%, 35.0%, and 57.1% of patients in DC arms A, B, C, and E, respectively. Efficacy was observed at all dose levels/schedules in patients with NSCLC. ORRs were 40.0% [95% confidence interval (a), 24.9-56.7; arm A], 37.5% (95% CI, 22.7-54.2; arm B), 27.5% (95% CI, 14.6-43.9; arm C), and 35.7% (95% a, 12.8-64.9; arm E). PD-L1 expression and total number of circulating CD4+ cells correlated with ORR. Conclusions: Quavonlimab 25 mg Q6W plus pembrolizumab demonstrated similar efficacy and a better safety profile among all quavonlimab doses/schedules evaluated; this regimen was the chosen RP2D. | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Safety and efficacy of quavonlimab, a novel anti-CTLA-4 antibody (MK-1308), in combination with pembrolizumab in first-line advanced non-small-cell lung cancer | - |
dc.type | Article | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.wosid | 000629497100015 | - |
dc.identifier.scopusid | 2-s2.0-85098213999 | - |
dc.citation.endpage | 403 | - |
dc.citation.number | 3 | - |
dc.citation.startpage | 395 | - |
dc.citation.volume | 32 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, D-W | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordAuthor | non-small-cell lung cancer | - |
dc.subject.keywordAuthor | quavonlimab | - |
dc.subject.keywordAuthor | MK-1308 | - |
dc.subject.keywordAuthor | CTLA-4 | - |
dc.subject.keywordAuthor | pembrolizumab | - |
dc.subject.keywordAuthor | immunotherapy | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.