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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)
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.
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.
Citations
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Abstract
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).
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
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.