Advanced NSCLC Combination Treatment

Study Design

EMPOWER-Lung 3 was designed with broad inclusion criteria1,2

Enrolled advanced NSCLC patients of any PD-L1 expression and both histologies1,2

Phase 3, randomized, multicenter, double-blind, active-controlled trial (N=466)1,3
Key eligibility criteria
  • Treatment-naive metastatic NSCLC
  • Locally advanced NSCLC, not candidates for surgical resection or definitive chemoradiation 
  • Any PD-L1 expression level
  • ECOG PS 0 or 1
Permitted for enrollment
  • Treated, clinically stable brain metastases*
  • Squamous and nonsquamous histology
  • Controlled hepatitis B, hepatitis C, or HIV
Exclusion criteria included:
  • EGFR, ALK, or ROS1 genomic tumor aberrations
  • A medical condition that required systemic immunosuppression
  • Uncontrolled infections with hepatitis B, hepatitis C, or HIV
  • Ongoing or recent autoimmune disease that required systemic therapy
LIBTAYO 350 mg IV Q3W for 108 weeks + platinum-based chemotherapy Q3W for 4 cycles (n=312)
R 2:1
Placebo IV Q3W for 108 weeks + platinum-based chemotherapy Q3W for 4 cycles(n=154)
Treat until RECIST 1.1-defined PD, unacceptable toxicity, or 108 weeks
Treat until RECIST 1.1-defined PD, unacceptable toxicity, or 108 weeks
Primary endpoint:

OS

Secondary endpoints included:

PFS (key), ORR (key), DOR, and safety and tolerability

In EMPOWER-Lung 3, OS was monitored and reviewed per IDMC. All secondary analyses were per BICR.

Per IDMC recommendation:

Trial stopped early due to superior OS3

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 3, OS was monitored and reviewed per IDMC. 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
  • No patients with HIV or hepatitis B were enrolled; only 2 patients with hepatitis C were enrolled.4
  • Investigator's choice: Paclitaxel + cisplatin or carboplatin for squamous NSCLC and pemetrexed + cisplatin or carboplatin for nonsquamous NSCLC. Mandatory pemetrexed maintenance for patients with nonsquamous histology initially assigned a pemetrexed-containing regimen.2
  • Randomization was stratified by histology (nonsquamous vs squamous) and PD-L1 expression (<1% vs 1% to 49% vs ≥50%) according to the VENTANA PD-L1 (SP263) assay.1
  • Median duration of treatment exposure was 38.5 weeks (IQR, 20.7-63.9 weeks) for LIBTAYO + chemotherapy and 21.3 weeks (IQR, 12.0-38.4 weeks) for placebo + chemotherapy.
  • ALK=anaplastic lympoma kinase; BICR=blinded independent committee review; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group Performance Status; EGFR=epidermal growth factor receptor; HIV=human immunodeficiency virus; IDMC=independent data monitoring committee; NSCLC=non-small cell lung cancer; ORR=overall response rate; PD-L1=programmed death ligand 1; PFS=progression-free survival; QW3=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 32
ITT (N=466)
%, unless stated
LIBTAYO + chemotherapy
(n=312)
Chemotherapy
(n=154)
Median age (range), years
Median age (range), years
63 (25-82)
63 (34-84)
≥65 years
41
39
 
LIBTAYO + chemo was examined in a clinical study designed to closely resemble a patient population with varied disease presentations that physicians manage in everyday clinical practice:1,5-8
43%

had squamous histology5

14%

had locally advanced disease and were ineligible for surgical resection or definitive chemoradiation7

8%

had treated, clinically stable brain metastases6*

16%

had liver metastases2

83%

had an ECOG PS of 18

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