Study Design
In patients who had no EGFR, ALK, or ROS1 aberrations:
EMPOWER-Lung 1 was designed to enroll advanced NSCLC patients
with PD-L1 ≥50%1
Phase 3, large, randomized, multicenter, open-label, active-controlled trial (ITT population; N=710)1,2,4
Key eligibility criteria
- Treatment-naive metastatic NSCLC
- Locally advanced NSCLC, not candidates for surgical resection or definitive chemoradiation
- PD-L1 ≥50%
- ECOG PS 0 or 1
Permitted for enrollment
- Treated, clinically stable brain metastases*
- Controlled hepatitis B, hepatitis C, or HIV†
- Type 1 diabetes mellitus or hypothyroidism only requiring hormone replacement
Exclusion criteria included:
- EGFR, ALK, or ROS1 genomic tumor abberations
- A medical condition that required systemic immunosuppression
- Uncontrolled infections with hepatitis B, hepatitis C, or HIV
- Autoimmune disease that required systemic therapy within 2 years of treatment
- Never-smokers
LIBTAYO single agent 350 mg IV Q3W
Treat until PD, unacceptable toxicity, or 108 weeks
(n=356)
R 1:1
Platinum-based chemotherapy
4 to 6 cycles†
(n=354)
Optional continuation of LIBTAYO + 4 cycles of chemotherapy§
PD
Optional crossover to LIBTAYO single agent||
Primary endpoints1
OS and PFS
Secondary endpoints included1,2
ORR (key), DOR, and safety and tolerability
In EMPOWER-Lung 1, OS was monitored and reviewed per IDMC; PFS and all secondary analyses were per BICR.1,2
The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.2
- A total of 710 patients were enrolled and randomized. For some patients, it was later determined that PD-L1 biomarker testing was not conducted according to the instructions for use, and required retesting2
- An analysis was conducted in a subset of patients with known PD-L1 ≥50% (n=563). The analysis excluded 91 patients from the overall population whose PD-L1 status was unknown because their tumors could not be retested, and 56 patients from the overall population who had <50% PD-L1 expression1 (LIBTAYO is not indicated in patients with <50% PD-L1 expression)
Per IDMC recommendation:
Trial stopped early due to superior OS2
The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1
- In EMPOWER-Lung 1, OS was monitored and reviewed per IDMC; PFS and all secondary analyses were per BICR.
- *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.1
- †Patients with HIV were allowed, but none were enrolled.1
- ‡Investigator’s choice: Paclitaxel + cisplatin or carboplatin; gemcitabine + cisplatin or carboplatin; or pemetrexed + cisplatin or carboplatin followed by optional pemetrexed maintenance in patients with nonsquamous histology.1
- §Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on therapy with LIBTAYO were permitted to continue treatment with LIBTAYO 350 mg Q3W for up to 108 additional weeks, along with the addition of histology-specific chemotherapy for 4 cycles until further disease progression was observed.1
- ||Patients who experienced IRC-assessed RECIST 1.1-defined progressive disease on chemotherapy were permitted to receive treatment with LIBTAYO for up to 108 weeks.1,3
- Randomization was stratified by histology (nonsquamous vs squamous) and geographic region (Europe vs Asia vs rest of world).1
- Median duration of exposure was 27.3 weeks (range, 9 days-115 weeks) for LIBTAYO vs 17.7 weeks (range, 18 days-86.7 weeks) for chemotherapy.1
- ALK=anaplastic lymphoma kinase; BICR=blinded independent committee review; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; HIV=human immunodeficiency virus; IDMC=independent data monitoring committee; ITT=intention-to-treat; IV=intravenous; ORR=objective response rate; OS=overall survival; PD=progressive disease;
PD-L1 =programmed death ligand 1; PFS=progression-free survival; PS=performance status; Q3W=every 3 weeks; R=randomization; RECIST=Response Evaluation Criteria in Solid Tumors; ROS1=ROS proto-oncogene 1, receptor tyrosine kinase.
Patient characteristics in EMPOWER-Lung 12,4
ITT (N=710)
%, unless stated
LIBTAYO
(n=356)
(n=356)
Chemotherapy
(n=354)
(n=354)
Median age (range), year
63 (31-79)
64 (40-84)
≥65 years
44
46
63 (31-79)
64 (40-84)
≥65 years
44
46
Male
88
83
88
83
Race
White
87
86
Black or African American
0.3
1
Asian
11
11
Hispanic or Latino Ethnicity
10
7
White
87
86
Black or African American
0.3
1
Asian
11
11
Hispanic or Latino Ethnicity
10
7
Brain metastases*
12
11
12
11
ECOG PS
0
27
27
1
73
73
0
27
27
1
73
73
Histology
Squamous
45
43
Nonsquamous
55
57
Squamous
45
43
Nonsquamous
55
57
Cancer stage at screening
Locally advanced
18
15
Metastatic
82
85
Locally advanced
18
15
Metastatic
82
85
Prior systemic therapy
Neoadjuvant
1
2
Adjuvant
3
4
Neoadjuvant
1
2
Adjuvant
3
4
- In the subset of patients with known PD-L1 ≥50% (n=563), baseline patient and disease characteristics were consistent with those in the ITT population2,4
LIBTAYO as a single agent was examined in a clinical study designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice:
12%
had treated, clinically stable brain metastases*
15%
had liver metastases
2%
had controlled hepatitis B or hepatitis C
18%
had locally advanced disease and were ineligible for surgical resection or definitive chemoradiation
(LIBTAYO only numbers)
- *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.1