NSCLC: IMpower150 trial

Abbreviations

No EU-CTR

Investigated (inv)
Comparator (comp)

ATEZ+BEVA+chemo (ABCP)

BEVA+chemo (BCP)

356

336

Phase:

3

Randomisation:

Open label

Primary tumour:

NSCLC

Subtype (biomarker):

Nonsquamous, Adenocarcinoma

Stage:

meta

Line of therapy:

L1

Primary
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
HR
p
PFS in WT
8.3 mo
6.8 mo
0.62 (0.52-0.74)
<0.001
OS in WT
19.2 mo
14.7 mo
0.78 (0.64-0.96)
0.02
Secondaries
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
HR
p
ORR
63.5%
48.0%
CR
3.7%
1.2%
DoR
9.0 mo
5.7 mo
DoR (Teff-high WT)
11.2 mo
5.7 mo
(all grades, %)
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
p
Alopecia
46.6
43.9
NA
Peripheral neuropathy
38.7
31.0
NA
Nausea
34.1
27.6
NA
Fatigue
25.7
22.6
NA
Anemia
23.9
23.8
NA
Diarrhea
20.6
15.2
NA
Neutropenia
18.3
17.3
NA
Hypertension
19.1
17.0
NA
Arthralgia
16.8
15.0
NA
Epistaxis
13.7
17.3
NA
Vomiting
14.2
14.2
NA
Thrombocytopenia
13.3
11.4
NA
Proteinuria
12.9
12.2
NA
Stomatitis
11.9
5.4
NA
  • Inclusion
  • Exclusion

- Eastern Cooperative Oncology Group performance status 0 or 1 - Histologically or cytologically confirmed, Stage IV non-squamous NSCLC - Participants with no prior treatment for Stage IV non-squamous NSCLC - Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumour tissue or tissue obtained from a biopsy at screening - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and organ function.

- Active or untreated central nervous system metastases - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with the expected curative outcome - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. - Positive test for human immunodeficiency virus - Active hepatitis B or hepatitis C - Severe infection within 4 weeks prior to randomization - Significant cardiovascular disease - Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures - Prior treatment with a cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.

Characteristics
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
Age & sex
Median age (range)
63 (31−89)
63 (31−90)
< 65 yr
215 (53.8%)
226 (56.5%)
65 - 84 yr
182 (45.4%)
171 (42.8%)
Maledc-comma no.
240 (60.0%)
239 (59.8%)
ECOG performance-status
0
159/397 (40.1%)
179/397 (45.1%)
1
238/397 (59.9%)
218/397 (54.9%)
History of tobacco use
Never
82 (20.5%)
77 (19.2%)
Current
90 (22.5%)
92 (23.0%)
Previous
228 (57.0%)
231 (57.8%)
Nonsquamous histologic subtype
Adenocarcinoma
378 (94.5%)
377 (94.2%)
Other
19 (4.8%)
17 (4.2%)
Unknown or not assessed
3 (0.8%)
6 (1.5%)
EGFR mutation status
Positive
35 (8.8%)
45 (11.3%)
Negative
352 (88.0%)
345 (86.3%)
EML4-ALK rearrangement status
Positive
13 (3.2%)
21 (5.2%)
Negative
383 (95.8%)
375 (93.8%)
KRAS mutation status
Positive
47 (11.8%)
38 (9.5%)
Negative
59 (14.8%)
77 (19.2%)
Liver metastases
Liver metastases absent at enrollment
347 (86.8%)
343 (85.8%)
Race or ethnic group
White
322 (80.5%)
335 (83.8%)
Asian
56 (14.0%)
46 (11.5%)
Black
3 (0.8%)
12 (3.0%)
Unknown
13 (3.2%)
6 (1.5%)
Ad-hoc:
no.pts inv.
no.pts comp.
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
HR
p
PFS in WT & Teff-high
11.3 mo
6.5 mo
0.51 (0.38-0.68)
<0.001
PFS (PD-L1 low/negdc-commaTeff-low)
8.0 mo
6.8 mo
0.68 (0.56-0.82)
PFS (PD-L1 high)
12.6 mo
6.8 mo
0.39 (0.25-0.60)
  • PFS in WT
  • OS in WT
analisys of PFS in WT
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
HR (95% CI)
Biomarkers
EGFR or ALK alterations
9.7
6.1
0.59 (0.37-0.94)
WT population
8.3
6.8
0.62 (0.52-0.74)
PD-L1 subgroups (in the WT population)
TC3 or IC3
12.6
6.8
0.39 (0.25-0.60]
TC1/2/3 or IC1/2/3
11
6.8
0.50 (0.39-0.64)
PD-L1 subgroups (in the WT population)
TC1/2 or IC1/2
8.3
6.6
0.56 (0.41-0.77)
TC0/1/2 and IC0/1/2
8
6.8
0.68 (0.56-0.82)
PD-L1 subgroups (in the WT population)
TC0 and IC0
7.1
6.9
0.77 (0.61-0.99)
Teff subgroups (in the WT population)
High gene-signature expression
11.3
6.8
0.51 (0.38–0.68)
Low gene-signature expression
7.3
7.0
0.76 (0.60–0.96)
analisys of OS in WT
ATEZ+BEVA+chemo (ABCP)
BEVA+chemo (BCP)
HR (95% CI)