Advanced NSCLC Monotherapy Treatment

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)
Chemotherapy
(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
 
88
83
88
83
 
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
 
12
11
12
11
 
0
27
27
1
73
73
0
27
27
1
73
73
 
Squamous
45
43
Nonsquamous
55
57
Squamous
45
43
Nonsquamous
55
57
 
Locally advanced
18
15
Metastatic
82
85
Locally advanced
18
15
Metastatic
82
85
 
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)

Explore Hypothetical Patient Profiles
  • *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.1