Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial.

Autor: Moreno V; START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, Spain., Roda D; University Hospital INCLIVA, Valencia, Spain., Pikiel J; Szpitale Pomorskie, Szpital Morski, Gdynia, Poland., Trigo J; Hospital Universitario Virgen de la Victoria, IBIMA, Málaga, Spain., Bosch-Barrera J; Catalan Institute of Oncology (ICO), Hospital Universitari Dr Josep Trueta, Girona, Spain., Drew Y; Clinical and Translational Institute, Newcastle University, Newcastle, UK., Kristeleit R; University College London Cancer Institute, UCL, London, UK., Hiret S; Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain, France., Bajor DL; University Hospitals Cleveland Medical Centre, Cleveland, OH., Cruz P; La Paz University Hospital, Madrid, Spain., Beck JT; Highlands Oncology Group, Springdale, AR., Ghosh S; GSK, Collegeville, PA., Dabrowski C; GSK, Collegeville, PA., Antony G; GSK, Brentford, UK., Duan T; GSK, Waltham, MA., Veneris J; GSK, Waltham, MA., Zografos E; GSK, Stevenage, Hertfordshire, UK., Subramanian J; Saint Luke's Cancer Institute, Kansas City, MO. Electronic address: janakiraman.subramanian@inova.org.
Jazyk: angličtina
Zdroj: Clinical lung cancer [Clin Lung Cancer] 2022 Nov; Vol. 23 (7), pp. e415-e427. Date of Electronic Publication: 2022 May 23.
DOI: 10.1016/j.cllc.2022.05.013
Abstrakt: Background: Dostarlimab is an anti-programmed cell death protein-1 antibody being evaluated in recurrent/advanced solid tumors, including non-small cell lung cancer (NSCLC), in the ongoing Phase I, multi-center, open-label, 2-part (dose escalation and cohort expansion) GARNET study (NCT02715284).
Materials and Methods: Here, we report an interim analysis of patients with recurrent/advanced NSCLC who progressed following platinum-based chemotherapy. Patients received dostarlimab (500 mg IV every 3 weeks [Q3W] for Cycles 1-4, then 1000 mg Q6W) until disease progression or unacceptable toxicity for > 2 years. The primary endpoints were immune-related objective response rate (irORR) per investigator-assessed irRECIST and safety.
Results: As of 8, July 2019, 67 patients with recurrent/advanced NSCLC were enrolled and treated with dostarlimab; the majority had programmed death ligand 1 (PD-L1) tumor proportion score (TPS) < 1% (35.8% of patients) or PD-L1 TPS 1%-49% (29.9% of patients); 7.5% had PD-L1 TPS ≥ 50%, and 26.9% had unknown PD-L1 TPS status. Median follow-up was 13.8 months (range: 0.0-22.6). irORR was 26.9%, including 2 complete and 16 partial responses. The median duration of response of 11.6 months (range: 2.8-19.4). Responses were observed in 2 of 24 (16.7%) patients with PD-L1 TPS < 1%, 4 of 20 (20.0%) patients with PD-L1 TPS 1%-49% and 2 of 5 (40.0%) patients with PD-L1 TPS ≥ 50%. Fatigue (4.5%) was the most common Grade ≥ 3 treatment-related treatment-emergent adverse event (TRAE). Immune-related TRAEs (any grade) were observed in 28.4% of patients.
Conclusion: Dostarlimab demonstrated promising antitumor activity in advanced/recurrent NSCLC that progressed following platinum-based chemotherapy, including across all PD-L1 subgroups, and has an acceptable safety profile.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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