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Virote Sriuranpong
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ES01 - Choosing Systemic Therapies After Chemoimmunotherapy in NSCLC (ID 147)
- Event: WCLC 2020
- Type: Educational Session
- Track: Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 09:15 - 10:15, Scientific Program Auditorium
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ES01.01 - Non-Squamous (ID 3939)
09:15 - 10:15 | Presenting Author(s): Virote Sriuranpong
- Abstract
- Presentation
Abstract not provided
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OA01 - Established Drugs in Special Populations and New Drugs in Established Populations (ID 226)
- Event: WCLC 2020
- Type: Oral
- Track: Immunotherapy (Phase II/III Trials)
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 09:15 - 10:15, Scientific Program Auditorium
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OA01.03 - Clinical Benefits of First-Line (1L) Cemiplimab Monotherapy by PD-L1 Expression Levels in Patients With Advanced NSCLC (ID 3035)
09:15 - 10:15 | Author(s): Virote Sriuranpong
- Abstract
- Presentation
Introduction
Despite approval of programmed cell death (PD)-1 inhibitor monotherapy as 1L treatment for advanced non-small cell lung cancer (NSCLC), the clinical significance of PD-ligand 1 (PD-L1) expression levels above the 50% threshold remains unclear.
Methods
EMPOWER-Lung 1 is a randomized, open-label, Phase 3 study of anti–PD-1 cemiplimab 350 mg every 3 weeks, versus platinum doublet chemotherapy, as 1L treatment in patients with advanced NSCLC and PD-L1 ≥50% (NCT03088540). This exploratory post-hoc analysis assesses the clinical benefits of study treatment by PD-L1 expression tertiles in a randomized sub-population (n=475) with PD-L1 ≥50% by 22C3 assay. Data cut-off was March 1, 2020.
Results
In the cemiplimab arm (n=238), 33.6%, 31.9%, and 34.5% of patients had PD-L1 ≥90%, >60% to <90%, and ≥50% to ≤60%, respectively; corresponding proportions in the chemotherapy arm (n=237) were 34.2%, 30.4%, and 35.4%, respectively. Overall, cemiplimab provided significantly better OS, PFS, and objective response rate (ORR) than chemotherapy, with incremental benefits by increasing PD‑L1 expression seen with cemiplimab, but not chemotherapy (Table). The largest difference in ORR between cemiplimab (38.8% [95% CI: 28.1–50.3]) and chemotherapy (14.8% [95% CI: 7.9–24.4]) was observed in patients with PD-L1 ≥90%. Depth of tumor size reduction was greater with cemiplimab than that of chemotherapy and correlated with PD-L1 levels (Figure). Median DOR has not been reached with cemiplimab (95% CI: 10.5–not evaluable) versus chemotherapy (6-months [95% CI: 4.3–8.3]). Kaplan–Meier estimated DOR >12 months was higher with cemiplimab (67.7% [95% CI: 45.7–82.3]) compared to chemotherapy (15.0% [95% CI: 1.5–42.6]).
Conclusion
Overall, the benefit (OS, PFS, and ORR) with cemiplimab was superior to chemotherapy, and incrementally associated with PD-L1 expression levels. Thus, baseline PD-L1 expression levels may be used to identify patients with advanced NSCLC who are most likely to derive greatest benefit from 1L cemiplimab monotherapy.
Table. Correlation of survival and objective response rate with baseline PD-L1 levels Overall survival Progression-free survival Tumor response Median, months
(95% CI)HR (95% CI) Median, months
(95% CI)HR (95% CI) ORR, % (95% CI) Overall NR (NE–NE)
vs.
12.1 (10.2–17.5)0.57
(0.40–0.80)6.3 (4.5–8.5)
vs.
5.6 (4.3–6.2)0.60
(0.47–0.77)35.3 (29.2–41.7)
vs.
17.7 (13.1–23.2)By PD-L1 expression tertile PD-L1 ≥90% NR (13.4–NE)
vs.
13.3 (10.2–NE)0.54
(0.27–1.10)12.7 (9.8–13.4)
vs.
6.1 (4.2–6.2)0.33
(0.19–0.58)38.8 (28.1–50.3)
vs.
14.8 (7.9–24.4)PD-L1 >60 to <90% NR (NE–NE)
vs.
14.2 (9.6–17.5)0.49
(0.26–0.92)6.2 (4.2–8.4)
vs.
4.3 (4.1–5.9)0.57
(0.38–0.85)39.5 (28.4–51.4)
vs.
16.7 (8.9–27.3)PD-L1 ≥50 to ≤60% NR (13.2–NE)
vs.
11.7 (8.3–NE)0.74
(0.44–1.24)4.3 (2.8–5.2)
vs.
6.0 (4.4–6.2)0.89
(0.61–1.29)28.0 (18.7–39.1)
vs.
21.4 (13.2–31.7)Median survival, and ORR data are shown for cemiplimab versus chemotherapy, respectively. ORR defined as the proportion of patients with a best overall response of confirmed complete or partial response. PFS in the PD-L1 ≥50 to ≤60% subgroup has the widest CIs which makes the PFS estimate HR highly unstable.
CI, confidence interval; HR, hazard ratio; NE, not evaluable; NR, not reached; ORR, objective response rate; PD-L1, programmed cell death-ligand 1; PFS, progression free survival.
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