Survival data from EMPOWER-Lung 4: Phase II study of cemiplimab plus ipilimumab in the second-line (2L) treatment of advanced non-small cell lung cancer (NSCLC)
AuthorsShim, B. Y.
Carpeno, J. D.
Chiu, C. H.
Kim, H. R.
Ryu, J. S.
Tarruella, M. M.
Summers, Yvonne J
Thomas, C. A.
AffiliationDepartment of Medical Oncology, St. Vincent’s Hospital, College of Medicine, The Catholici University of Korea, Suwon, Republic of Korea;
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AbstractBackground: EMPOWER-Lung 4 is a phase II study evaluating cemiplimab monotherapy, and combination therapy with cemiplimab + ipilimumab, as 2L treatment in patients (pts) with advanced NSCLC and programmed cell death-ligand 1 (PD-L1) <50%.We previously reported on this study, showing that numerically better objective response rates (ORR) were observed with cemiplimab + ipilimumab vs cemiplimab monotherapy. Here, we present follow-up data including survival outcomes not previously reported. Methods: Pts received cemiplimab 350 mg every 3 weeks (Q3W) (Arm A); or cemiplimab 350 mg Q3W plus ipilimumab 50 mg every 6 weeks (Arm B); or cemiplimab 1050 mg Q3W (Arm C), for up to 108 weeks or until progression. Primary endpoint was ORR per independent review committee (IRC). Data cut-off was 30 Jun 2020. Results: Of 28 pts enrolled, 27 received treatment (Arm A, n = 8;ArmB, n = 11; and Arm C, n = 8). Median duration of treatment exposurewas 10.8 (Arm A), 17.9 (Arm B) and 10.8 (Arm C)weeks. Median follow-upwas 2.6 (Arm A), 17.4 (Arm B) and 3.9 (Arm C) months. ORR (95% confidence interval [CI]) remained unchanged since the previous report: 0% (0.0– 36.9%) in Arm A, 45.5% (16.7–76.6%) in Arm B, and 11.1% (0.3–48.2%) in Arm C, with a median duration of response not reached (NR) in Arm B and 11.2 months in Arm C. Median overall survival (OS) (95% CI) per IRC was 5.1 months (1.7–not evaluable [NE]) in Arm A, NR (2.2–NE) in Arm B and 8.4 months (0.3–NE) in Arm C. Median progression-free survival (PFS)(95%CI) per IRCwas 2.0months (0.7–8.3) inArmA,NR(1.2–NE)in ArmBand 1.8 months (0.3–12.7) inArmC. Grade≥3 treatment-emergent adverse events (AEs) occurred in 25.0% (Arm A), 72.7% (Arm B) and 75.0%(ArmC) of pts. Across all arms, increased alanine aminotransferase was the only Grade ≥3 immune-related AE reported in >1 pt (n = 2 [18.2%]; both in Arm B). Conclusions: This follow-up analysis which includes OS/PFS data shows that combination of ipilimumab 50 mg with cemiplimab 350 mg provides additional survival improvement in pts with advanced NSCLC and PD-L1 <50%. Moreover, consistency in ORR with the previous analysis demonstrates durability of responses to cemiplimab 350 mg + ipilimumab 50 mg.
CitationShim BY, Lee S, Carpeño J de C, Chiu C-H, Cobo M, Kim HR, et al. 115P Survival data from EMPOWER-Lung 4: Phase II study of cemiplimab plus ipilimumab in the second-line (2L) treatment of advanced non-small cell lung cancer (NSCLC). Journal of Thoracic Oncology. 2021 Apr;16(4):S760.
JournalJournal of Thoracic Oncology
TypeMeetings and Proceedings