An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations.

Autor: Chouaid C; Service de Pneumologie, Pneumology, Intercommunal Hospital, 40 avenue de Verdun, 94010, Créteil, France. christos.chouaid@chicreteil.fr., Bosquet L; Health Data and Partnerships Department, Unicancer, Paris, France., Girard N; Institut Curie, Paris, France., Kron A; Lung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.; Network Genomic Medicine, Cologne, Germany.; Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Scheffler M; Lung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.; Network Genomic Medicine, Cologne, Germany.; Department I of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany., Griesinger F; Department of Hematology and Oncology, University Department Internal Medicine-Oncology, Pius-Hospital, University Medicine Oldenburg, Oldenburg, Germany., Sebastian M; Department of Medicine, Hematology and Oncology, University of Frankfurt, Frankfurt, Germany., Trigo J; Hospital Universitario Virgen de la Victoria y Regional, IBIMA, Malaga, Spain., Viteri S; UOMI Cancer Center, Clínica Mi Tres Torres, Barcelona, Spain.; Instituto Oncológico Dr Rosell, Hospital Universitari Dexeus, Grupo QuironSalud, Barcelona, Spain., Knott C; Health Data Insight CIC, Cambridge, UK.; National Disease Registration Service, NHS Digital, Leeds, UK., Rodrigues B; Janssen Cilag, Porto Salvo, Portugal., Rahhali N; Janssen Cilag, Île-de-France, France., Cabrieto J; Janssen Pharmaceutica NV, Beerse, Belgium., Diels J; Janssen Pharmaceutica NV, Beerse, Belgium., Perualila NJ; Janssen Pharmaceutica NV, Beerse, Belgium., Schioppa CA; Janssen Pharmaceutica NV, Beerse, Belgium., Sermon J; Janssen Pharmaceutica NV, Beerse, Belgium., Toueg R; Janssen Cilag, Île-de-France, France., Erdmann N; Janssen-Cilag GmbH, Neuss, Germany., Mielke J; Janssen-Cilag GmbH, Neuss, Germany., Nematian-Samani M; Janssen-Cilag GmbH, Neuss, Germany., Martin-Fernandez C; Janssen-Cilag Ltd, High Wycombe, UK., Pfaira I; Janssen-Cilag Ltd, High Wycombe, UK., Li T; Janssen R&D, Raritan, NJ, USA., Mahadevia P; Janssen R&D, Raritan, NJ, USA., Wolf J; Lung Cancer Group Cologne, Department I for Internal Medicine and Center for Integrated Oncology Cologne/Bonn, University Hospital Cologne, Cologne, Germany.; Network Genomic Medicine, Cologne, Germany.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2023 Mar; Vol. 40 (3), pp. 1187-1203. Date of Electronic Publication: 2023 Jan 18.
DOI: 10.1007/s12325-022-02408-7
Abstrakt: Introduction: Patients with advanced, epidermal growth factor receptor (EGFR)-mutated, non-small cell lung cancer (NSCLC) with Exon 20 insertion mutations (Exon20ins) have poor prognoses, exacerbated by a previous lack of specific treatment guidelines and unmet need for targeted therapies. Amivantamab, an EGFR and MET bispecific antibody, demonstrated efficacy and tolerability in patients with advanced EGFR-mutated NSCLC with Exon20ins following platinum-based therapy in CHRYSALIS (NCT02609776; Cohort D+). Since CHRYSALIS was single-arm, individual patient data (IPD)-based adjusted analyses versus similar patients in real-world clinical practice (RWCP) were conducted to generate comparative evidence.
Methods: RWCP cohorts were derived from seven European and US real-world sources, comprising patients fulfilling CHRYSALIS Cohort D+ eligibility criteria. Amivantamab was compared with a basket of RWCP treatments. Differences in prognostic characteristics were adjusted for using inverse probability weighting (IPW; average treatment effect among the treated [ATT]). Balance between cohorts was assessed using standardized mean differences (SMDs). Overall response rate (ORR; investigator- [INV] and independent review committee-assessed [IRC]), overall survival (OS), progression-free survival (PFS; INV and IRC) and time-to-next treatment (TTNT) were compared. Binary and time-to-event endpoints were analyzed using weighted logistic regression and proportional hazards regression, respectively.
Results: Pre-adjustment, baseline characteristics were comparable between cohorts. IPW ATT-adjustment improved comparability, giving closely matched characteristics. ORR (INV) was 36.8% for amivantamab versus 17.0% for the adjusted EU + US cohort (response rate ratio [RR]: 2.16). Median OS, PFS (INV) and TTNT were 22.77 versus 12.52 months (hazard ratio [HR]: 0.47; p < 0.0001), 6.93 versus 4.17 months (HR: 0.55; p < 0.0001) and 12.42 versus 5.36 months (HR: 0.44; p < 0.0001) for amivantamab versus the adjusted EU + US cohort, respectively. Results were consistent versus EU- and US-only cohorts, and when using IRC assessment.
Conclusion: Adjusted comparisons demonstrated significantly improved outcomes for amivantamab versus RWCP, highlighting the value of amivantamab in addressing unmet need in patients with advanced EGFR Exon20ins NSCLC following platinum-based therapy.
Trial Registration: CHRYSALIS: NCT02609776.
(© 2023. The Author(s).)
Databáze: MEDLINE
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