Cabozantinib Plus Atezolizumab or Cabozantinib Alone in Patients With Advanced NSCLC Previously Treated With an Immune Checkpoint Inhibitor : Results From the Phase 1b COSMIC-021 Study
Neal, Joel W. (Stanford Cancer Institute (Palo Alto, California))
Santoro, Armando (IRCCS Humanitas Research Hospital (Milà, Itàlia))
González-Cao, María (Hospital Universitari Dexeus (Barcelona, Catalunya))
Lim, Farah Louise (St Bartholomew's Hospital (Londres, Regne Unit))
Fang, Bruno (East Brunswick (Nova Jersey, Estats Units d'Amèrica))
Gentzler, Ryan D. (University of Virginia Cancer Center)
Goldschmidt, Jerome (University of Virginia Cancer Center)
Khrizman, Polina (MD Anderson Cancer Center at Cooper (Nova Jersey, Estats Units d'Amèrica))
Proto, Claudia (Fondazione IRCCS Istituto Nazionale dei Tumori)
Patel, Shiven (University of Utah)
Puri, Sonam (University of Utah)
Liu, Stephen V. (Georgetown Lombardi Comprehensive Cancer Center (Washington, Estats Units d'Amèrica))
Massarelli, Erminia (City of Hope Comprehensive Cancer Center (Duarte, California))
Williamson, Denise (Exelixis (Alameda, Estas Units d'Amèrica))
Schwickart, Martin (Exelixis (Alameda, Estas Units d'Amèrica))
Scheffold, Christian (Exelixis (Alameda, Estas Units d'Amèrica))
Andrianova, Svetlana (Exelixis (Alameda, Estas Units d'Amèrica))
Felip, Enriqueta (Vall d'Hebron Institut d'Oncologia)

Date:	2024
Abstract:	We evaluated efficacy and safety of cabozantinib plus atezolizumab or cabozantinib alone in advanced NSCLC previously treated with an immune checkpoint inhibitor (ICI). COSMIC-021 (NCT03170960) is a phase 1b, multicenter study in advanced solid tumors. This analysis included patients with stage IV non-squamous NSCLC without actionable genomic aberrations in EGFR, ALK, ROS1, or BRAF - V600E who progressed on one prior ICI and less than or equal to two prior lines of systemic anticancer therapy. Patients received cabozantinib 40 mg orally/day plus atezolizumab 1200 mg intravenously every three weeks (combination cohort) or cabozantinib 60 mg orally/day (single-agent cabozantinib cohort). Primary end point of the combination cohort was objective response rate per Response Evaluation Criteria in Solid Tumors v1. 1 by investigator. Outcomes in the single-agent cabozantinib cohort were exploratory. Eighty-one patients assigned to combination therapy and 31 assigned to single-agent cabozantinib received greater than or equal to one dose of study treatment. Median (range) follow-up was 26. 1 months (12. 1-44. 2) and 22. 4 months (1. 5-29. 0), respectively. Objective response rate was 20% (95% confidence interval: 11. 7%-30. 1%) in combination cohort and 6% (95% confidence interval: 0. 8%-21. 4%) in single-agent cabozantinib cohort. Treatment-related adverse events (TRAEs) occurred in 86% of patients in the combination cohort and 90% in the single-agent cabozantinib cohort; grade 3/4 TRAEs were 44% and 48%, respectively. There were two grade 5 TRAEs: pneumonitis (n = 1, combination) and gastric ulcer hemorrhage (n = 1, single-agent). Neither PD-L1 expression in tumor cells nor tumor mutation burden correlated with outcomes. Cabozantinib plus atezolizumab demonstrated modest clinical activity and manageable toxicity in advanced NSCLC after progression on prior ICI.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Cabozantinib ; Atezolizumab ; Non-small cell lung cancer ; Immunotherapy
Published in:	JTO Clinical and Research Reports, Vol. 5 (march 2024) , ISSN 2666-3643

DOI: 10.1016/j.jtocrr.2024.100666
PMID: 39318387

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