36 / 45
•
Co-primary endpoints were PFS and OS in the ITT and PD-L1+ populations
d
•
Key secondary efficacy endpoints (ORR and DOR) and safety were also evaluated
Schmid P, et al. IMpassion130
ESMO 2018 (LBA1_PR)
http://bit.ly/2DMhaygIC, tumour-infiltrating immune cell; TFI, treatment-free interval.
a
ClinicalTrials.gov: NCT02425891.
b
Locally evaluated per ASCO–College of American Pathologists
(CAP) guidelines.
c
Centrally evaluated per VENTANA SP142 IHC assay (double blinded for PD-L1 status).
d
Radiological endpoints were investigator assessed
(per RECIST v1.1).
Key IMpassion130 eligibility criteria
a
:
• Metastatic or inoperable locally advanced TNBC
‒ Histologically documented
b
• No prior therapy for advanced TNBC
‒ Prior chemo in the curative setting, including
taxanes, allowed if TFI ≥ 12 mo
• ECOG PS 0-1
Stratification factors:
• Prior taxane use (yes vs no)
• Liver metastases (yes vs no)
• PD-L1 status on IC (positive [≥ 1%] vs negative [< 1%])
c
Atezo + nab-P arm:
Atezolizumab
840 mg IV
‒ On days 1 and 15 of 28-day cycle
+
nab
-paclitaxel
100 mg/m
2
IV
‒ On days 1, 8 and 15 of 28-day cycle
Plac + nab-P arm:
Placebo IV
‒ On days 1 and 15 of 28-day cycle
+
nab
-paclitaxel 100 mg/m
2
IV
‒ On days 1, 8 and 15 of 28-day cycle
Double blind; no crossover permitted
RECIST v1.1
PD or toxicity
R
1:1
N:902