Advanced NSCLC Combination Treatment

PFS AND RESPONSE
RATES

Secondary Endpoints

In patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations

EXTENDED Progression-free survival: Median 8.2 months

with LIBTAYO + chemo* vs 5.0 months with chemo in EMPOWER-Lung 31,2

LIBTAYO + chemotherapy EMPOWER-Lung 3 PROGRESSION FREE SURVIVAL DATA
  • Adapted with permission from Gogishvili et al, Nat Med. 2022.
  • *chemo=platinum-based chemotherapy
  • HR was based on stratified proportional hazards model.1
  • CI=confidence interval; HR=hazard ratio; PFS=progression free survival.
44%

Reduction in risk of progression HR=0.56

(95% Cl, 0.44–0.70),
P<0.00011

  • Number of events: 65% of patients (204 out of 312 patients) with LIBTAYO + chemotherapy and 79% of patients (122 out of 154 patients) with chemotherapy alone1

Exploratory Analysis of Prespecified Histology Subgroup1,3

Limitations:

This is an exploratory analysis that was not powered to show a statistically significant difference in histologies. Firm conclusions
cannot be made based on these exploratory analyses.

Squamous
Median PFS, months (95% CI)
LIBTAYO +
chemotherapy (n=133)
Chemotherapy
(n=67)
8.2 (6.3-10.4)
4.9 (4.1-6.2)
HR (95% CI)
0.56 (0.40-0.79)
  • Number of events (squamous): 74% of patients (98 out of 133) with LIBTAYO + chemotherapy and 81% of patients (54 out of 67) with chemotherapy alone
Nonsquamous
Median PFS, months (95% CI)
LIBTAYO +
chemotherapy (n=179)
Chemotherapy
(n=87)
7.9 (6.3-10.4)
5.5 (4.3-6.2)
HR (95% CI)
0.53 (0.39-0.73)
  • Number of events (nonsquamous): 59% of patients (106 out of 179) with LIBTAYO + chemotherapy and 78% of patients (68 out of 87) with chemotherapy alone
  • HR <1 favors LIBTAYO.
  • Advanced NSCLC is locally advanced NSCLC where patients are not candidates for surgical resection of definitive chemoradiation or metastatic NSCLC

In patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations

ORR was significantly HIGHER in patients treated with LIBTAYO + chemo* vs chemo alone1

43% ORR
(95% CI, 38%-49%) P<0.0001
41% PR   2.6% CR
LIBTAYO + chemotherapy
(n=312)
23% ORR
(95% CI, 16%-30%) P<0.0001
23% PR 0% CR
Chemotherapy
(n=154)
  • CR: Disappearance of all target lesions. Disappearance of all nontarget lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm (<1cm).
  • PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Exploratory Analysis of Prespecified Histology Subgroup2

Limitations:

This is an exploratory analysis that was not powered to show a statistically significant difference in histologies. Firm
conclusions cannot be made based on these exploratory analyses.

Squamous
ORR, %
LIBTAYO +
chemotherapy (n=133)
Chemotherapy
(n=67)
47%
28%
2.21 (1.17-4.15)
Nonsquamous
ORR, %
LIBTAYO +
chemotherapy (n=179)
Chemotherapy
(n=87)
41%
18%
OR (95% CI)
3.06 (1.65-5.68)
  • *chemo=platinum-based chemotherapy
  • OR >1 favors LIBTAYO.
  • Advanced NSCLC is locally advanced NSCLC where patients are not candidates for surgical resection of definitive chemoradiation or metastatic NSCLC
  • CR=complete response; OR=odds ratio; ORR=objective response rate; PR=partial response.

In patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations

Extended duration of response: Median DOR of 15.6 months

with LIBTAYO + chemo* vs. 7.3 months with chemo alone1,2

Median DOR
15.6 months
(range, 1.7-18.7+ months)
7.3 months
(range, 1.8-18.8+ months)
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Month
  • Based on patients with confirmed CR or PR.
  • *chemo=platinum-based chemotherapy
  • +: Ongoing response.
  • CR=complete response; DOR=duration of response; PR=partial response.