Advanced NSCLC Monotherapy Treatment

PFS AND RESPONSE
RATES

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

LIBTAYO significantly EXTENDED PROGRESSION-FREE SURVIVAL vs platinum-based
chemotherapy in EMPOWER-Lung 11,2

LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 1 PROGRESSION FREE SURVIVAL DATA, ITT population.
  • Adapted with permission from Sezer et al, Lancet. 2021 supplementary appendix.2
41%

Reduction in risk of progressive disease HR=0.59

(95% Cl, 0.49-0.72)
P<0.0001

Median PFS: 6.2 months
(95% CI, 4.5-8.3) with LIBTAYO vs 5.6 months (95% CI,
4.5-6.1) with chemotherapy1
  • Number of events: 57% of patients (201 out of 356 patients) with LIBTAYO and 74% of
    patients (262 out of 354 patients) with chemotherapy1
  • *Patients with locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation or who have metastatic NSCLC.1
  • HR based on stratified proportional hazards model.1

Response rates in EMPOWER-Lung 1

Objective response rate‡§

LIBTAYO (n=356)
37% ORR
(95% CI, 32%-42%)
33% PR   3% CR
Chemotherapy (n=354)
21% ORR
(95% CI, 17%-25%)
20% PR   1% CR

Duration of response

Median DOR
21 months
(range, 1.9+-23.3+ months)
6 months
(range, 1.3+-16.5+ months)
0 2 4 6 8 10 12 14 16 18 20 22
Month
  • §Clopper-Pearson exact confidence interval.1
  • Per BICR.1
  • +: Ongoing response.1
  • CI=confidence interval; CR=complete response; DOR=duration of response; HR=hazard ratio; PFS=progression free survival; PR=partial response; ORR= objective response rate.

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):

Progression-free survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 11,2

Progression-free survival with LIBTAYO vs platinum-based chemotherapy in EMPOWER-Lung 1, known PD-L1≥ 50%
  • Adapted with permission from Sezer et al, Lancet. 2021.1
46%

Reduction in risk of progressive disease HR=0.54

(95% Cl, 0.43-0.68)
P<0.0001

Median PFS: 8.2 months
(95% CI, 6.1-8.8) with LIBTAYO vs 5.7 months (95% CI,
4.5-6.2) with chemotherapy1,2
  • Number of events: 52% of patients (147 out of 283 patients) with LIBTAYO and 70% of
    patients (197 out of 280 patients) with chemotherapy1,2
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
  • HR based on stratified proportional hazards model.1

Response rates in EMPOWER-Lung 1

Objective response rate‡§||

LIBTAYO (n=283)
39% ORR
(95% CI, 34%-45%)
37% PR   2% CR
Chemotherapy (n=280)
20% ORR
(95% CI, 16%-26%)
19% PR   1% CR

Duration of response‡||

Median DOR
16.7 months
(range, 1.9+-23.3+ months)
6 months
(range, 1.3+-14.5+ months)
0 2 4 6 8 10 12 14 16 18 20 22
Month
  • Per BICR.3,4
  • §Clopper-Pearson exact confidence interval.3,4
  • ||Not a prescribed endpoint in the 564-patient population with PD-L1 ≥50%.5
  • +: Ongoing response.4
  • CI=confidence interval; CR=complete response; DOR=duration of response; HR=hazard ratio; PFS=progression free survival; PR=partial response; ORR= objective response rate.