Reference Detail

Ref Type

PMID

Authors

Mustafa Ozguroglu, Ahmet Sezer, Saadettin Kilickap, Mahmut Gumus, Igor Bondarenko, Miranda Gogishvili, Haci M. Turk, Irfan Cicin, Dmitry Bentsion, Oleg Gladkov, Philip R. Clingan, Virote Sriuranpong, Naiyer A. Rizvi, Jennifer McGinniss, Jean-Francois Pouliot, Sue Lee, Frank A. Seebach, Israel Lowy, Giuseppe Gullo, Petra Rietschel

Title

Cemiplimab monotherapy as first-line (1L) treatment of patients with brain metastases from advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥ 50%: EMPOWER-Lung 1 subgroup analysis.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Journal of Clinical Oncology	39	no. 15_suppl	May 20, 2021

URL

https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.9085

Abstract Text

Background: In the Phase 3, EMPOWER-Lung 1 study, cemiplimab monotherapy provided significant survival benefit and an acceptable safety profile vs chemotherapy in patients with advanced NSCLC and PD-L1 ≥50%. EMPOWER-Lung 1 included patients with brain metastases at baseline who are typically underrepresented in clinical trials. Other published exploratory analyses in single-cohort studies suggest benefit from immunotherapy in this patient population. Here, we present subgroup analysis of patients with brain metastasis from EMPOWER-Lung 1. Methods: Patients were randomized 1:1 to cemiplimab 350 mg IV every 3 weeks or investigator’s choice of chemotherapy (NCT03088540). Patients with treated, clinically stable brain metastases (radiological stability not required) were eligible to enroll and are the focus of this subgroup analysis from the PD-L1 ≥50% population (n=563) of the EMPOWER-Lung 1 study. Results: A total of 68 of 563 (12.1%) cases had treated stable brain metastases at time of randomization. Patients were evenly distributed between cemiplimab (n=34) and chemotherapy (n=34), with similar median duration of follow-up (Table). Baseline characteristics were generally similar; median (range) age: 60.0 (45–76 ) vs 62.0 (48–77); male: 97.1% vs 85.3%; and non-squamous histology: 85.3% vs 76.5%; between cemiplimab vs chemotherapy, respectively. Per independent review committee, median overall survival (OS, 18.7 vs 11.7 months), median progression-free survival (PFS, 10.4 vs 5.3 months), and objective response rate (ORR, 41.2% vs 8.8%) were superior with cemiplimab vs chemotherapy (Table). After baseline, central nervous system (CNS) disease progression occurred in 2 (5.9%) patients with cemiplimab vs 4 (11.8%) patients with chemotherapy; extra-CNS disease progression occurred in 9 (26.5%) patients with cemiplimab vs 15 (44.1%) patients with chemotherapy. Conclusions: 1L cemiplimab monotherapy improved OS, PFS, and ORR vs chemotherapy, in patients with advanced NSCLC with PD-L1 ≥50%, and clinically stable brain metastases at baseline. Cemiplimab monotherapy represents a suitable option for this subgroup of patients. Clinical trial information: NCT03088540.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 over exp	lung non-small cell carcinoma	sensitive	Cemiplimab	Phase III	Actionable	In a phase III trial (EMPOWER-Lung 1), Libtayo (cemiplimab) therapy improved overall survival (18.7 vs 11.7 mo, HR 0.17, p=0.0091), progression-free survival (10.4 vs 5.3 mo, HR 0.45, p=0.0231), and objective response rate (41.2% vs 8.8%) compared to chemotherapy in patients with advanced non-small cell lung cancer with CD274 (PD-L1) expression equals to or over 50% and with brain metastases at baseline (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 9085-9085; NCT03088540).	detail...