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)1-3
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
R 1:1
LIBTAYO monotherapy 350 mg IV Q3W

Treat until PD, unacceptable toxicity, or 108 weeks
(n=356)
Platinum-based chemotherapy
4 to 6 cycles
(n=354)
PD
Optional continuation of LIBTAYO + 4 cycles of chemotherapy
Optional crossover to LIBTAYO monotherapy§
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; and never-smokers.

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)

Primary endpoints1

OS and PFS

Secondary endpoints included1,2

ORR (key), DOR, and safety and tolerability

All primary and secondary analyses were conducted per blinded independent central review.1,2


Per IDMC recommendation

Trial stopped early due to superior OS.2

LIBTAYO was examined in a clinical study that included historically underrepresented patients with advanced NSCLC1,2:

In the LIBTAYO arm (ITT patient population) at baseline, 12% of patients had treated and clinically stable brain metastases,* 18% had locally advanced disease, and 2% had controlled hepatitis B or hepatitis C. Patients with HIV were permitted to enroll, but none were recruited.1,2,4

Explore Hypothetical Patient Profiles

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

  • *Patients were eligible if they had been adequately treated and had neurologically returned to baseline for at least 2 weeks prior to randomization.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; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; HIV=human immunodeficiency virus; IDMC=independent data monitoring committee; IRC=independent review 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)
n (%), unless stated
LIBTAYO
(n=356)
Chemotherapy
(n=354)
Median age (range), year
63 (31-79)
64 (40-84)
≥65 years
156 (44)
164 (46)
63 (31-79)
64 (40-84)
≥65 years
156 (44)
164 (46)
 
312 (88)
294 (83)
312 (88)
294 (83)
 
White
308 (87)
305 (86)
Black or African American
1 (0.3)
3 (1)
Asian
39 (11)
38 (11)
Hispanic or Latino Ethnicity
36 (10)
26 (7)
White
308 (87)
305 (86)
Black or African American
1 (0.3)
3 (1)
Asian
39 (11)
38 (11)
Hispanic or Latino Ethnicity
36 (10)
26 (7)
 
44 (12)
39 (11)
44 (12)
39 (11)
 
0
96 (27)
96 (27)
1
260 (73)
258 (73)
0
96 (27)
96 (27)
1
260 (73)
258 (73)
 
Squamous
159 (45)
152 (43)
Nonsquamous
197 (55)
202 (57)
Squamous
159 (45)
152 (43)
Nonsquamous
197 (55)
202 (57)
 
Locally advanced
63 (18)
52 (15)
Metastatic
293 (82)
302 (85)
Locally advanced
63 (18)
52 (15)
Metastatic
293 (82)
302 (85)
 
Neoadjuvant
4 (1)
7 (2)
Adjuvant
9 (3)
15 (4)
Neoadjuvant
4 (1)
7 (2)
Adjuvant
9 (3)
15 (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

References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. 3. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274)(suppl):1-178. 4. Data on file. Regeneron Pharmaceuticals, Inc.