EMPOWER-lung 4: Phase II, randomized, open-label high dose or standard dose cemiplimab alone/plus ipilimumab in the secondline treatment of advanced non-small cell lung cancer (NSCLC)
Authors
Shim, B. Y.Lee, S.
Carpeno, J. D.
Chiu, C. H.
Cobo, M.
Kim, H. R.
Ryu, J. S.
Tarruella, M. M.
Summers, Yvonne J
Thomas, C. A.
Xu, Y.
Lowy, I.
Rietschel, P.
Affiliation
Department of Medical Oncology, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon, Gyeonggi-do, Republic of KoreaIssue Date
2020
Metadata
Show full item recordAbstract
Background: Programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitors have become key treatment options for advanced NSCLC without EGFR, ALK, or ROS1 mutations. Here, we report on the antitumour activity of cemiplimab, an antiePD-1, alone or plus ipilimumab (an anti-cytotoxic T-lymphocyte-associated protein 4 agent) in second- line (2L) advanced NSCLC. Methods: Patients with advanced NSCLC were randomised (1:1:1; stratified by histology and PD-L1 status) to receive cemiplimab 350 mg once every 3 weeks (Q3W) (Arm A); or cemiplimab 350 mg Q3W plus ipilimumab 50 mg once every 6 weeks (Q6W) (up to 4 doses) (Arm B); or cemiplimab 1050mgQ3W(ArmC), for up to 108weeks or until disease progression. Primary endpoint was objective response rate (ORR) in patients with PD-L1 expression <50%, per independent central review. Data cut-off was 28 Aug 2019. Results: Of 28 patients enrolled, 27 received treatment (Arm A, n¼8; Arm B, n¼11; and Arm C, n¼8). Median (range) age was 68 (46e80) years; 71.4% were male; 39.3% had prior radiotherapy; 67.9% had non-squamous NSCLC; and 57.1% had a PD-1 level <1%. Median duration of treatment exposure was 10.8 (Arm A), 17.9 (Arm B), and 10.8 (Arm C) weeks. ORR (95% confidence interval) was 0% (0.0e36.9%) in Arm A, 45.5% (16.7e76.6%) in Arm B and 11.1% (0.3e48.2%) in Arm C. For patients with PDL1 levels <1%, ORR was 36.4% (Arm B), and 11.1% (Arm C); for patients with PD-L1 levels of 1e49%, ORR was 9.1% (Arm B), and 0% (Arm C). Median duration of response (DOR) has not been reached; observed DOR was 2+ to 6.9+ (Arm B) and 4.8+ months (Arm C). Most common treatment-emergent adverse events of any grade were decreased appetite and constipation (each 37.5%) in Arm A; hypothyroidism and pneumonia (each 36.4%) in Arm B; and decreased appetite (37.5%) in Arm C. Across all arms, increased alanine aminotransferase was the only Grade _3 immune-related adverse event reported in >1 patient (Arm B; 18.2%). Conclusions: In patients with advanced NSCLC and <50% PD-L1 expression, 2L combination treatment with cemiplimab 350 mg + ipilimumab 50 mg exhibited numerically higher antitumour activity than cemiplimab monotherapy (350 or 1050 mg).Citation
Shim BY, Lee S, de Castro Carpeño J, Chiu CH, Cobo M, Kim HR, et al. 1269P EMPOWER-lung 4: Phase II, randomized, open-label high dose or standard dose cemiplimab alone/plus ipilimumab in the second-line treatment of advanced non-small cell lung cancer (NSCLC). Annals of Oncology. 2020;31:S820-S.Journal
Annals of OncologyDOI
10.1016/j.annonc.2020.08.1583Additional Links
https://dx.doi.org/10.1016/j.annonc.2020.08.1583Type
Meetings and ProceedingsLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.annonc.2020.08.1583