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MyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: Pertuzumab + Trastuzumab Treatment of a Tissue-Agnostic Cohort of Patients With Human Epidermal Growth Factor Receptor 2-Altered Advanced Solid Tumors

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dc.contributor.authorSweeney, C.J.
dc.contributor.authorHainsworth, J.D.
dc.contributor.authorBose, R.
dc.contributor.authorBurris, H.A.
dc.contributor.authorKurzrock, R.
dc.contributor.authorSwanton, C.
dc.contributor.authorFriedman, C.F.
dc.contributor.authorSpigel, D.R.
dc.contributor.authorSzado, T.
dc.contributor.authorSchulze, K.
dc.contributor.authorPrice, R.
dc.contributor.authorMalato, J.
dc.contributor.authorLo, A.A.
dc.contributor.authorLevy, J.
dc.contributor.authorWang, Y.
dc.contributor.authorYu, W.
dc.contributor.authorMeric-Bernstam, F.
dc.date.issued2024
dc.description.abstractClinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondaryanalyses arenotyetavailable.Clinical TrialUpdatesprovideanopportunitytodisseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The MyPathway multiple-basket study (ClinicalTrials.gov identifier: NCT02091141) is evaluating targeted therapies in nonindicated tumors with relevant molecular alterations. We assessed pertuzumab 1trastuzumab ina tissue-agnostic cohort of adult patients with human epidermal growth factor receptor 2 (HER2)–amplified and/or–overexpressed and/or–mutated solid tumors. The primary end point was objective response rate (ORR); secondary end points included survival and safety. At data cutoff (March 2022), 346 patients with HER2 amplification and/or overexpression with/without HER2 mutations (n 5 263), or HER2 mutations alone (n 5 83) had been treated. Patients with HER2 amplification and/or overexpression had an ORR of 25.9% (68/263, 95% CI, 20.7 to 31.6), including five complete responses (urothelial [n 5 2], salivary gland [n 5 2], and colon [n 5 1] cancers). Activity was higherinthosewithwild-type(ORR,28.1%)versusmutatedKRAS(ORR,7.1%).Amongpatients with HER2 amplification, ORR wasnumerically higher in patients with immunohistochemistry (IHC)31(41.0%;32/78)or21(21.9%;7/32),versus11(8.3%;1/12)ornoexpression(0%;0/20). InpatientswithHER2mutationsalone,ORRwas6.0%(5/83,95%CI,2.0to13.5).Pertuzumab1 trastuzumab showed activity in various HER2-amplified and/or-overexpressed tumors with wild-type KRAS, withtherange ofactivity dependent on tumor type,buthadlimitedactivity in the context of KRAS mutations, HER2 mutations alone, or 0-11 HER2 expression.
dc.description.statementofresponsibilityJohn D. Hainsworth, Ron Bose, Christopher J. Sweeney, Charles Swanton, Claire F. Friedman, David R. Spigel, Howard A. Burris, Razelle Kurzrock, Tania Szado, Katja Schulze, Richard Price, Julia Malato, Amy A. Lo, Funda Meric-Bernstam
dc.identifier.citationJournal of Clinical Oncology, 2024; 42(3):258-265
dc.identifier.doi10.1200/jco.22.02636
dc.identifier.issn0732-183X
dc.identifier.issn1527-7755
dc.identifier.orcidSweeney, C.J. [0000-0002-0398-6018]
dc.identifier.urihttps://hdl.handle.net/2440/141565
dc.language.isoen
dc.publisherAmerican Society of Clinical Oncology
dc.rights© 2023 by American Society of Clinical Oncology. Creative Commons Attribution Non-Commercial No Derivatives 4.0 License
dc.source.urihttps://doi.org/10.1200/jco.22.02636
dc.subjectPertuzumab; trastuzumab; tissue-agnostic cohort; solid tumors
dc.subject.meshHumans
dc.subject.meshNeoplasms
dc.subject.meshReceptor, erbB-2
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshAdult
dc.subject.meshProto-Oncogene Proteins p21(ras)
dc.subject.meshAntibodies, Monoclonal, Humanized
dc.subject.meshTrastuzumab
dc.titleMyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: Pertuzumab + Trastuzumab Treatment of a Tissue-Agnostic Cohort of Patients With Human Epidermal Growth Factor Receptor 2-Altered Advanced Solid Tumors
dc.typeJournal article
pubs.publication-statusPublished

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