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Conference Paper: KEYNOTE-495/KeyImPaCT, a randomized, phase 2, biomarker-directed trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC)

TitleKEYNOTE-495/KeyImPaCT, a randomized, phase 2, biomarker-directed trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC)
Authors
Issue Date2019
PublisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/
Citation
The 44th European Society for Medical Oncology (ESMO) Congress (ESMO 2019), Barcelona, Spain, 27 September – 1 October 2019. Abstract Book In Annals of Oncology, 2019, v. 30 n. Suppl. 5, p. 656, abstract no. 1589TiP How to Cite?
AbstractBackground: KEYNOTE-495 is a randomized, open-label, phase II trial (NCT03516981) evaluating the clinical activity and safety of pembrolizumab (pembro)-based combination (combo) therapy in patients (pts) with treatment-naive, advanced NSCLC in biomarker-defined response groups. This biomarker-based approach is based on 2 validated, independent, next-generation biomarkers (T cell–inflamed gene expression profile [GEP] and tumor mutational burden [TMB]) and can help determine the differential efficacy of pembro-based combo therapy, based on the composite biomarker profile, and inform precision immunotherapy in the future. Trial design: In this group-sequential, adaptive randomized trial, pts (N∼288) receive pembro 200 mg Q3W intravenously (IV) combined with MK-4280 (anti–LAG-3) 200 mg Q3W IV, lenvatinib (lenv) 20 mg PO QD, or MK-1308 (anti–CTLA-4) 25 mg Q6W IV for 35 cycles (∼2 years); pts in the lenv arm may receive lenv monotherapy until disease progression or toxicity. After biomarker screening, pts are assigned to 1 of 4 groups—TMBlowGEPlow, TMBhighGEPlow, TMBlowGEPhigh, and TMBhighGEPhigh—then randomized to 1 of 3 pembro-based regimens; adaptive design elements are used to adjust randomization based on objective responses. Eligible pts are ≥18 years of age with histologically or cytologically confirmed treatment-naive, advanced NSCLC; documented absence of EGFR and B-Raf mutations and ALK and ROS1 gene rearrangements; measurable disease per RECIST v1.1; and ECOG PS 0-1. Response is assessed by imaging Q9W for the first year and Q12W thereafter using RECIST v1.1. Primary end point is investigator-assessed objective response rate (RECIST v1.1). Secondary end points are progression-free survival, overall survival, and safety. Multiple interim analyses may be performed given the group-sequential design. Enrollment is ongoing. Clinical trial identification: NCT03516981: Trial initiation, October 1, 2018.
DescriptionPoster Display session 1: Non-Small Cell Lung Cancer - no. 1589TiP
First interim results
Persistent Identifierhttp://hdl.handle.net/10722/279578
ISSN
2017 Impact Factor: 13.93
2015 SCImago Journal Rankings: 4.362

 

DC FieldValueLanguage
dc.contributor.authorGutierrez, M-
dc.contributor.authorLam, WS-
dc.contributor.authorHellmann, MD-
dc.contributor.authorGubens, CA-
dc.contributor.authorAggarwal, C-
dc.contributor.authorTan, DSW-
dc.contributor.authorFelip, E-
dc.contributor.authorChiu, WYJ-
dc.contributor.authorLee, JS-
dc.contributor.authorYang, JCH-
dc.contributor.authorGaron, EB-
dc.contributor.authorBasso, A-
dc.contributor.authorMa, H-
dc.contributor.authorFong, L-
dc.contributor.authorSnyder, A-
dc.contributor.authorYuan, J-
dc.contributor.authorHerbst, RS-
dc.date.accessioned2019-11-01T07:20:02Z-
dc.date.available2019-11-01T07:20:02Z-
dc.date.issued2019-
dc.identifier.citationThe 44th European Society for Medical Oncology (ESMO) Congress (ESMO 2019), Barcelona, Spain, 27 September – 1 October 2019. Abstract Book In Annals of Oncology, 2019, v. 30 n. Suppl. 5, p. 656, abstract no. 1589TiP-
dc.identifier.issn0923-7534-
dc.identifier.urihttp://hdl.handle.net/10722/279578-
dc.descriptionPoster Display session 1: Non-Small Cell Lung Cancer - no. 1589TiP-
dc.descriptionFirst interim results-
dc.description.abstractBackground: KEYNOTE-495 is a randomized, open-label, phase II trial (NCT03516981) evaluating the clinical activity and safety of pembrolizumab (pembro)-based combination (combo) therapy in patients (pts) with treatment-naive, advanced NSCLC in biomarker-defined response groups. This biomarker-based approach is based on 2 validated, independent, next-generation biomarkers (T cell–inflamed gene expression profile [GEP] and tumor mutational burden [TMB]) and can help determine the differential efficacy of pembro-based combo therapy, based on the composite biomarker profile, and inform precision immunotherapy in the future. Trial design: In this group-sequential, adaptive randomized trial, pts (N∼288) receive pembro 200 mg Q3W intravenously (IV) combined with MK-4280 (anti–LAG-3) 200 mg Q3W IV, lenvatinib (lenv) 20 mg PO QD, or MK-1308 (anti–CTLA-4) 25 mg Q6W IV for 35 cycles (∼2 years); pts in the lenv arm may receive lenv monotherapy until disease progression or toxicity. After biomarker screening, pts are assigned to 1 of 4 groups—TMBlowGEPlow, TMBhighGEPlow, TMBlowGEPhigh, and TMBhighGEPhigh—then randomized to 1 of 3 pembro-based regimens; adaptive design elements are used to adjust randomization based on objective responses. Eligible pts are ≥18 years of age with histologically or cytologically confirmed treatment-naive, advanced NSCLC; documented absence of EGFR and B-Raf mutations and ALK and ROS1 gene rearrangements; measurable disease per RECIST v1.1; and ECOG PS 0-1. Response is assessed by imaging Q9W for the first year and Q12W thereafter using RECIST v1.1. Primary end point is investigator-assessed objective response rate (RECIST v1.1). Secondary end points are progression-free survival, overall survival, and safety. Multiple interim analyses may be performed given the group-sequential design. Enrollment is ongoing. Clinical trial identification: NCT03516981: Trial initiation, October 1, 2018.-
dc.languageeng-
dc.publisherOxford University Press. The Journal's web site is located at http://annonc.oxfordjournals.org/-
dc.relation.ispartofAnnals of Oncology-
dc.relation.ispartof44th European Society for Medical Oncology (ESMO) Congress (ESMO 2019)-
dc.titleKEYNOTE-495/KeyImPaCT, a randomized, phase 2, biomarker-directed trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC)-
dc.typeConference_Paper-
dc.identifier.emailChiu, WYJ: jwychiu@hku.hk-
dc.identifier.authorityChiu, WYJ=rp01917-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1093/annonc/mdz260.111-
dc.identifier.hkuros308515-
dc.identifier.volume30-
dc.identifier.issueSuppl. 5-
dc.identifier.spage656, abstract no. 1589TiP-
dc.identifier.epage656, abstract no. 1589TiP-
dc.publisher.placeUnited Kingdom-

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