SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer.
Beckwith H, Medgyesy D, Abraham J, Nanda R, Tkaczuk K, Krop I, Pusztai L, Modi S, Mita M, Specht J, Hurvitz S, Han H, Kalinsky K, Wilks S, O'Shaughnessy J, Hart L, Rugo H, Mitri Z, Garfin P, Burris III H. SGNLVA-001: A phase I open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer. Journal Of Clinical Oncology 2020, 38: tps1104-tps1104. DOI: 10.1200/jco.2020.38.15_suppl.tps1104.Peer-Reviewed Original ResearchMetastatic breast cancerMonomethyl auristatin EDose-expansion cohortsAntibody-drug conjugatesDose escalationBreast cancerRECIST v1.1Expansion cohortPrior linesCytotoxic chemotherapyMetastatic triple-negative breast cancerGrade 2 peripheral neuropathyInvestigational antibody-drug conjugateNegative metastatic breast cancerLIV-1Triple-negative breast cancerAdequate organ functionHumanized IgG1 monoclonal antibodyKey efficacy endpointsPrimary safety endpointProgression-free survivalDose-limiting toxicityDuration of responseOverall response rateMonths of completionA phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL.
Loi S, McArthur H, Harbeck N, Pusztai L, Delaloge S, Letrent K, Chen T, Li B, Tatsuoka K, Zardavas D, Curigliano G. A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL. Journal Of Clinical Oncology 2020, 38: tps604-tps604. DOI: 10.1200/jco.2020.38.15_suppl.tps604.Peer-Reviewed Original ResearchAdjuvant endocrine therapyPathologic complete responsePrimary breast cancerEndocrine therapyNeoadjuvant chemotherapyBreast cancerNeoadjuvant phaseER expressionGlobal phase 3 studyDeath ligand 1 (PD-L1) expressionLong-term clinical outcomesAdequate organ functionDeath-1 (PD-1) inhibitionLow ER expressionAxillary nodal statusDisease-free survivalEvent-free survivalLigand 1 expressionPhase III trialsResidual cancer burdenPhase 3 studyOverall response rateRisk of relapseValid surrogate endpointQuality of life