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Amivantamab plus lazertinib in osimertinib-relapsed <i>EGFR</i>-mutant advanced non-small cell lung cancer: a phase 1 trial
DC Field | Value | Language |
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dc.contributor.author | Cho, Byoung Chul | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Spira, Alexander I. | - |
dc.contributor.author | Gomez, Jorge E. | - |
dc.contributor.author | Haura, Eric B. | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Sanborn, Rachel E. | - |
dc.contributor.author | Cho, Eun Kyung | - |
dc.contributor.author | Lee, Ki Hyeong | - |
dc.contributor.author | Minchom, Anna | - |
dc.contributor.author | Lee, Jong-Seok | - |
dc.contributor.author | Han, Ji-Youn | - |
dc.contributor.author | Nagasaka, Misako | - |
dc.contributor.author | Sabari, Joshua K. | - |
dc.contributor.author | Ou, Sai-Hong Ignatius | - |
dc.contributor.author | Lorenzini, Patricia | - |
dc.contributor.author | Bauml, Joshua M. | - |
dc.contributor.author | Curtin, Joshua C. | - |
dc.contributor.author | Roshak, Amy | - |
dc.contributor.author | Gao, Grace | - |
dc.contributor.author | Xie, John | - |
dc.contributor.author | Thayu, Meena | - |
dc.contributor.author | Knoblauch, Roland E. | - |
dc.contributor.author | Park, Keunchil | - |
dc.date.accessioned | 2023-10-30T01:43:40Z | - |
dc.date.available | 2023-10-30T01:43:40Z | - |
dc.date.created | 2023-10-24 | - |
dc.date.created | 2023-10-24 | - |
dc.date.created | 2023-10-24 | - |
dc.date.created | 2023-10-24 | - |
dc.date.created | 2023-10-24 | - |
dc.date.created | 2023-10-24 | - |
dc.date.issued | 2023-10 | - |
dc.identifier.citation | Nature Medicine, Vol.29 No.10, pp.2577-2585 | - |
dc.identifier.issn | 1078-8956 | - |
dc.identifier.uri | https://hdl.handle.net/10371/195815 | - |
dc.description.abstract | Patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) often develop resistance to current standard third-generation EGFR tyrosine kinase inhibitors (TKIs); no targeted treatments are approved in the osimertinib-relapsed setting. In this open-label, dose-escalation and dose-expansion phase 1 trial, the potential for improved anti-tumor activity by combining amivantamab, an EGFR-MET bispecific antibody, with lazertinib, a third-generation EGFR TKI, was evaluated in patients with EGFR-mutant NSCLC whose disease progressed on third-generation TKI monotherapy but were chemotherapy naive (CHRYSALIS cohort E). In the dose-escalation phase, the recommended phase 2 combination dose was established; in the dose-expansion phase, the primary endpoints were safety and overall response rate, and key secondary endpoints included progression-free survival and overall survival. The safety profile of amivantamab and lazertinib was generally consistent with previous experience of each agent alone, with 4% experiencing grade >= 3 events; no new safety signals were identified. In an exploratory cohort of 45 patients who were enrolled without biomarker selection, the primary endpoint of investigator-assessed overall response rate was 36% (95% confidence interval, 22-51). The median duration of response was 9.6 months, and the median progression-free survival was 4.9 months. Next-generation sequencing and immunohistochemistry analyses identified high EGFR and/or MET expression as potential predictive biomarkers of response, which will need to be validated with prospective assessment. | - |
dc.language | 영어 | - |
dc.publisher | Nature Publishing Group | - |
dc.title | Amivantamab plus lazertinib in osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1038/s41591-023-02554-7 | - |
dc.citation.journaltitle | Nature Medicine | - |
dc.identifier.wosid | 001068088400002 | - |
dc.identifier.scopusid | 2-s2.0-85171288172 | - |
dc.citation.endpage | 2585 | - |
dc.citation.number | 10 | - |
dc.citation.startpage | 2577 | - |
dc.citation.volume | 29 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | TYROSINE KINASE INHIBITORS | - |
dc.subject.keywordPlus | ANTIBODY TARGETING EGFR | - |
dc.subject.keywordPlus | BISPECIFIC ANTIBODY | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PROTEIN EXPRESSION | - |
dc.subject.keywordPlus | 1ST-LINE TREATMENT | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | NSCLC | - |
dc.subject.keywordPlus | MULTICENTER | - |
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