Lung icon, Advanced NSCLC Monotherapy Treatment

Efficacy
Overview

Approved in patients with advanced NSCLC* with PD-L1 ≥50% and no EGFR, ALK, or ROS1 aberrations1

Efficacy in patients who received LIBTAYO in EMPOWER-Lung 11
ITT (N=710)
LIBTAYO
(n=356)
Chemotherapy
(n=354)
OS
Median, months (95% CI)
22.1 (17.7-NE)
14.3 (11.7-19.2)
HR (95% CI)§
0.68 (0.53-0.87)
P-value
0.0022
Deaths, n (%)
108 (30)
141 (40)
 
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.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
  • Based on Kaplan-Meier method.1
  • §Based on stratified proportional hazards model.1
  • ||Clopper-Pearson exact confidence interval.1
  • += Ongoing response;1 BICR=blinded independent central review; CI=confidence interval; CR=complete response; DOR=duration of response; HR=hazard ratio; ITT=intention-to-treat; NE=not estimable; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PR=partial response.

In an analysis of the subset of patients with advanced NSCLC* who had no EGFR, ALK, or ROS1 aberrations and known PD-L1 ≥50% (n=563):

Efficacy in patients who received LIBTAYO in EMPOWER-Lung 11-3
Known PD-L1 ≥50% (n=563)
LIBTAYO
(n=283)
Chemotherapy
(n=280)
OS
Median, months (95% CI)
NR (17.9-NE)
14.2 (11.2-17.5)
HR (95% CI)§
0.57 (0.42-0.77)
P-value
0.0002
Deaths, n (%)
70 (25)
105 (38)
 

The EMPOWER-Lung 1 study was designed to enroll patients with PD-L1 ≥50%.1

  • 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 retesting1
  • 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)
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.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
  • Based on Kaplan-Meier method.1,2
  • §Based on stratified proportional hazards model.3
  • ||Clopper-Pearson exact confidence interval.1
  • Not a prespecified endpoint in the 563-patient population with PD-L1 ≥50%.3
  • +:Ongoing response;1 BICR=blinded independent central review; CI=confidence interval; CR=complete response; DOR=duration of response; HR=hazard ratio; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PR=partial response; NE=not estimable; NR=not reached.