Breast cancer: IMpassion130 trial

Abbreviations

No EU-CTR

Investigated (inv)
Comparator (comp)

ATEZ+nabpac

PLB+nabpac

451

451

Phase:

3

Randomisation:

Single blind

Primary tumour:

Breast

Subtype (biomarker):

TNBC

Stage:

meta

Line of therapy:

L1

Primary
ATEZ+nabpac
PLB+nabpac
HR
p
PFS (ITT)
7.2 mo
5.5 mo
0.80 (0.69-0.92)
0.002
PFS (PD-L1+)
7.5 mo
5.0 mo
0.62 (0.49-0.78)
<0.001
Secondaries
ATEZ+nabpac
PLB+nabpac
HR
p
OS (ITT)
21.3 mo
17.6 mo
0.84 (0.69-1.02)
0.08
OS (PD-L1+)
25.0 mo
15.5 mo
0.62 (0.45-0.86)
NA
ORR (ITT)
56.0%
45.9%
0.66 (0.51-0.82)
0.002
ORR (PD-L1+)
58.9%
42.6%
0.51 (0.34-0.78)
0.002
(all grades, %)
ATEZ+nabpac
PLB+nabpac
p
Any AE leading to discontinuation
15.9
8.2
NA
Alopecia
56.4
38.1
NA
Nausea
46.0
38.1
NA
Cough
24.8
18.9
NA
Peripheral neuropathy
21.7
22.1
NA
Neutropenia
20.8
15.3
NA
Pyrexia
18.8
10.7
NA
Immune-related hypothyroidism
17.3
4.3
NA
Immune-related hepatitis (all)
15.3
14.2
NA
Immune-related hyperthyroidism
4.4
1.4
NA
Anemia
24.8
22.6
NA
Diarrhea
23.5
24.7
NA
Constipation
13.1
11.9
NA
Dysgeusia
12.4
13.0
NA
  • Inclusion
  • Exclusion

- Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression - No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC - Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control) - A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor - Eastern Cooperative Oncology Group performance status of 0 or 1 - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and end-organ function.

- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases - Leptomeningeal disease - Pregnancy or lactation - History of autoimmune disease - Prior allogeneic stem cell or solid organ transplantation - Positive test for human immunodeficiency virus - Active hepatitis B or hepatitis C - Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo.

Characteristics
ATEZ+nabpac
PLB+nabpac
Age
Median (range) yr
55 (20-82)
56 (26-86)
18 - 40 yr
63 (14.0%)
51 (11.3%)
41 - 64 yr
284 (63.0%)
285 (63.2%)
≥65 yr
104 (23.1%)
115 (25.5%)
ECOG performance-status score
0
56.9%
60.0%
1
42.9%
39.8%
2
0.2%
0.2%
Metastatic disease
Metastatic disease
89.8%
90.7%
0 - 3 site of meta.
73.8%
75.9%
≥ 4 site of meta.
26.2%
24.1%
Site of metastatic disease
Liver
27.9%
26.2%
Bone
32.2%
31.3%
Brain
6.7%
6.9%
Lung
50.1%
53.7%
Previous therapy
Neoadjuvant or adjuvant therapy
63.0%
63.4%
Taxane
51.2%
51.0%
Anthracycline
53.9%
53.7%
Ad-hoc:
no.pts inv.
no.pts comp.
ATEZ+nabpac
PLB+nabpac
HR
p
PFS (PD-L1+)
185
184
7.5 mo
5.0 mo
0.62 (0.49-0.78)
<0.001
OS (PD-L1+)
185
184
25.0 mo
15.5 mo
0.62 (0.45-0.86)
NA
  • PFS (ITT)
  • PFS (PD-L1+)
analisys of PFS (ITT)
ATEZ+nabpac
PLB+nabpac
HR (95% CI)
PD-L1 status (mo.)
Positive
7.5
5.0
0.64 (0.51–0.80)
Negative
5.6
5.6
0.95 (0.79–1.15)
Age
41 - 64 yr
6.7
5.5
0.84 (0.70–1.01)
≥ 65
9.1
6.2
0.69 (0.51–0.94)
ECOG performance-status score
0
7.4
5.7
0.78 (0.64–0.94)
1
5.6
4.5
0.82 (0.66–1.03)
Baseline disease status
Locally advanced
9.6
5.5
0.66 (0.40–1.09)
Metastatic
6.6
5.5
0.82 (0.71–0.96)
No. of metastatic sites
0-3
8.2
5.6
0.76 (0.64–0.91)
>3
4.0
3.7
0.89 (0.67–1.17)
Liver metastases
Yes
5.3
3.7
0.80 (0.62–1.04)
No
7.5
5.6
0.79 (0.66–0.94)
Lung metastases
Yes
5.7
5.5
0.87 (0.72–1.07)
No
8.2
5.5
0.74 (0.60–0.91)
Previous NADJ or ADJ chemo
Yes
7.2
5.6
0.85 (0.71–1.03)
No
7.0
5.4
0.72 (0.57–0.92)
Previous taxane treatment
Yes
5.7
5.5
0.80 (0.65–0.97)
No
7.2
5.5
0.81 (0.66–1.00)
Previous anthracycline treatment
Yes
6.4
5.5
0.90 (0.74–1.10)
No
7.3
5.5
0.70 (0.56–0.87)
analisys of PFS (PD-L1+)
ATEZ+nabpac
PLB+nabpac
HR (95% CI)
Age
41-64 yr
7.7
5.0
0.67 (0.50-0.90)
≥65 yr
9.4
5.5
0.48 (0.30-0.79)
ECOG PS
0
8.6
5.5
0.65 (0.48-0.88)
1
7.4
3.6
0.60 (0.42-0.86)
Baseline disease status
Locally advanced
9.6
5.5
0.44 (0.22-0.89)
Metastatic
7.4
3.9
0.66 (0.51-0.84)
No. of metastatic sites
0-3
8.7
5.5
0.66 (0.51-0.86)
>3
5.5
3.3
0.56 (0.35-0.91)
Liver metastases
Yes
5.4
3.4
0.71 (0.44-1.13)
No
9.0
5.5
0.61 (0.47-0.80)
Lung metastases
Yes
7.2
4.7
0.73 (0.53-1.01)
No
9.0
5.3
0.55 (0.39-0.77)
Previous NADJ or ADJ chemo
Yes
7.4
5.5
0.76 (0.57-1.01)
No
9.4
3.8
0.45 (0.30-0.67)
Previous taxane treatment
Yes
6.1
5.5
0.74 (0.54-1.01)
No
8.6
3.9
0.54 (0.38-0.76)
Previous anthracycline treatment
Yes
6.4
5.5
0.82 (0.60-1.11)
No
9.4
3.9
0.45 (0.31-0.65)
Bone metastases
Yes
5.7
3.6
0.62 (0.41-0.95)
No
8.6
5.5
0.63 (0.48-0.84)