Real-world outcomes associated with afatinib use in patients with solid tumors harboring NRG1 gene fusions.

Autor: Liu SV; Georgetown University, Washington, DC 20007, USA. Electronic address: Stephen.V.Liu@gunet.georgetown.edu., Frohn C; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany., Minasi L; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877, USA., Fernamberg K; Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877, USA., Klink AJ; Real-world Evidence and Insights, Cardinal Health Specialty Solutions, Dublin, OH, USA., Gajra A; Real-world Evidence and Insights, Cardinal Health Specialty Solutions, Dublin, OH, USA; Hematology Oncology Associates of CNY, East Syracuse, NY 13057, USA., Savill KMZ; Real-world Evidence and Insights, Cardinal Health Specialty Solutions, Dublin, OH, USA., Jonna S; Durham Veterans Affairs Hospital, Durham, NC 27705, USA.
Jazyk: angličtina
Zdroj: Lung cancer (Amsterdam, Netherlands) [Lung Cancer] 2024 Feb; Vol. 188, pp. 107469. Date of Electronic Publication: 2024 Jan 05.
DOI: 10.1016/j.lungcan.2024.107469
Abstrakt: Objectives: Neuregulin-1 (NRG1) fusions may drive oncogenesis via constitutive activation of ErbB signaling. Hence, NRG1 fusion-driven tumors may be susceptible to ErbB-targeted therapy. Afatinib (irreversible pan-ErbB inhibitor) has demonstrated activity in individual patients with NRG1 fusion-positive solid tumors. This study collected real-world data on demographics, clinical characteristics, and clinical outcomes in this patient population.
Materials and Methods: In this retrospective, multicenter, non-comparative cohort study, physicians in the US-based Cardinal Health Oncology Provider Extended Network collected data from medical records of patients with NRG1 fusion-positive solid tumors who received afatinib (afatinib cohort) or other systemic therapies (non-afatinib cohort) in any therapy line. Objectives included demographics, clinical characteristics, and outcomes (overall response rate [ORR], progression-free survival [PFS], and overall survival [OS]).
Results: Patients (N = 110) with a variety of solid tumor types were included; 72 received afatinib, 38 other therapies. In the afatinib cohort, 70.8 % of patients received afatinib as second-line treatment and Eastern Cooperative Oncology Group performance status (ECOG PS) was 2-4 in 69.4 % at baseline. In the non-afatinib cohort, 94.7 % of patients received systemic therapy as first-line treatment and ECOG PS was 2-4 in 31.6 % at baseline. In the afatinib cohort, ORR was 37.5 % overall (43.8 % when received as first-line therapy); median PFS and OS were 5.5 and 7.2 months, respectively. In the non-afatinib cohort, ORR was 76.3 %; median PFS and OS were 12.9 and 22.6 months, respectively.
Conclusion: This study provides real-world data on the characteristics of patients with NRG1 fusion-positive solid tumors treated with afatinib or other therapies; durable responses were observed in both groups. However, there were imbalances between the cohorts, and the study was not designed to compare outcomes. Further prospective/retrospective trials are required.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Stephen V. Liu: Research funding: Alkermes, Bayer, Blueprint, Bristol Myers Squibb, Elevation Oncology, Genentech, Gilead, Merck, Merus, Nuvalent, Pfizer, Rain Therapeutics, RAPT, Turning Point Therapeutics. Consultancy: Abbvie, Amgen, AstraZeneca, Bayer, Beigene, Blueprint, Boehringer Ingelheim, Bristol Myers Squibb, Catalyst, Daiichi Sankyo, Eisai, Elevation Oncology, Genentech/Roche, Gilead, Guardant Health, Janssen, Jazz Pharmaceuticals, Lilly, Merck/MSD, Novartis, Regeneron, Sanofi, Takeda, Turning Point Therapeutics. Claas Frohn: Employment: Boehringer Ingelheim. Lori Minasi: Employment: Boehringer Ingelheim. Kristie Fernamberg: Employment: Boehringer Ingelheim. Andrew J. Klink: Employment: Cardinal Health. Ownership/stock interest: Cardinal Health. Ajeet Gajra: Employment: Cardinal Health. Advisory/consulting: G1therapeutics, AstraZeneca, Aveo Oncology, Cellectar. Kristin M. Zimmerman Savill: Employment: Cardinal Health. Sushma Jonna: No potential conflict of interest to declare.
(Copyright © 2024. Published by Elsevier B.V.)
Databáze: MEDLINE
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