Details of data from NSCLC clinical trials

Investigated (inv)

Comparator (comp)

NIVO

PCT

271

270

Phase:

3

Randomisation:

Open label

Primary tumour:

NSCLC

Subtype (biomarker):

Any

Stage:

Line of therapy:

L1

Primary

NIVO

PCT

HR

p

PFS

4.2 mo

5.9 mo

1.15 (0.91-1.45)

0.25 OS

—

Secondaries

NIVO

PCT

HR

p

OS

14.4 mo

13.2 mo

1.02 (0.80-1.30)

—

ORR (PD-L1≥5%)

26%

33%

1.43 (0.94-2.17)

—

DoR

12.1 mo

5.7 mo

—

Time to response

2.8 mo

2.6 mo

—

(all grades, %)

NIVO

PCT

p

Fatigue

21

35 NA

Diarrhea

14

13 NA

Nausea

12

48 NA

Rash

10

6 NA

Vomiting

6

23 NA

Anemia

3

43 NA

Thrombocytopenia

1

14 NA

Neutropenia

0

18 NA

Any AE leading to discontinuation of therapy

10

13 NA

Constipation

3

11 NA

Asthenia

3

11 NA

—

Inclusion
Exclusion

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 - Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumours version (RECIST) 1.1 criteria - PD-L1+ on immunohistochemistry testing performed by the central lab - Men and women, ages ≥ 18 years of age.

- Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy - Known anaplastic lymphoma kinase (ALK) translocations - Untreated central nervous system (CNS) metastases - Previous malignancies - Active, known or suspected autoimmune disease.

Characteristics

NIVO

PCT

Age & sex

Median age (range) yr

63 (32-89)

65 (29-87)

≥ 75 yr

30 (11%)

32 (12%)

Femaledc-comma no.

87 (32%)

122 (45%)

—

Disease stage

Stage IV

255 (94%)

244 (90%)

Recurrent

16 (6%)

25 (9%)

Not reported

0.0 1 (<1%)

—

ECOG performance-status

0 85 (31%)

93 (34%)

1 183 (68%)

174 (64%)

≥ 2

2 (1%)

3 (1%)

Not reported

1 (<1%)

0.0 Smoking status

Never smoked

30 (11%)

29 (11%)

Former smoker

186 (69%)

182 (67%)

Current smoker

52 (19%)

55 (20%)

Unknown

3 (1%)

4 (1%)

Previous systemic therapy

Adjuvant

22 (8%)

25 (9%)

Neoadjuvant

5 (2%)

4 (1%)

Previous radiotherapy

102 (38%)

107 (40%)

—

Tumor histologic findings

Squamous-cell carcinoma

66 (24%)

64 (24%)

Nonsquamous-cell carcinoma

205 (76%)

206 (76%)

—

Selected site of metastatic lesions

Brain

33 (12%)

36 (13%)

Liver

54 (20%)

36 (13%)

—

Sum of target-lesion diameters

Mediandc-comma mm

82

68 Rangedc-comma mm

14 - 218

15 - 272

—

PD-L1 expression level

≥ 5%

208 (77%)

210 (78%)

≥ 50%

88 (32%)

126 (47%)

—

Ad-hoc:

no.pts inv.

no.pts comp.

NIVO

PCT

HR

p

PFS (high TMB)

—

9.7 mo

5.8 mo

0.62 (0.38–1.00)

—

PFS (low TMB)

—

4.1 mo

6.9 mo

1.82 (1.30–2.55)

—

PFS
OS

analisys of PFS

NIVO

PCT

HR (95% CI)

Age

≥65 yr.

4.2

5.4 1.21 (0.91–1.62)

<65 yr.

4.5

6.8 1.17 (0.88–1.56)

Sex

Male

5.1

5.5 1.05 (0.81–1.37)

Female

3.6

6.6 1.36 (0.98–1.90)

ECOG

0

5.4

7.2 1.69 (1.18–2.42)

≥1

4

5.4 1.01 (0.79–1.30)

Histology

Squamous

5.1

4.6 0.83 (0.54–1.26)

Nonsquamous

4.2

6.8 1.29 (1.02–1.63)

Smoking status

Never smoked

2.8

6.8 2.51 (1.31–4.83)

Former smoker

4.2

5.7 1.14 (0.89–1.47)

Smoking status

Current smoker

5.4

6.8 1.03 (0.66–1.62)

—

PD-L1 expression level

≥50%

5.4

5.8 1.07 (0.77–1.49)

—

analisys of OS

NIVO

PCT

HR (95% CI)

Age

<65 yr

14.1

16.7 1.13 (0.83–1.54)

≥65 yr

13.3

11.0 1.04 (0.77–1.41)

Sex

Male

13.1

10.8 0.97 (0.74–1.26)

Female

16.6

17.3 1.15 (0.79–1.66)

ECOG

0

16.6

18.0 1.11 (0.74–1.66)

≥1

12.7

11.0 1.02 (0.79–1.32)

Histology

Squamous

10.5

10.2 0.82 (0.54–1.24)

Nonsquamous

14.5

16.7 1.17 (0.91–1.52)

Smoking status

Never smoked

13.7

12.5 1.02 (0.54–1.93)

Former smoker

14.1

13.3 1.09 (0.84–1.42)

Smoking status

Current smoker

14.3

17.1 1.05 (0.63–1.74)

—

PD-L1 expression level

≥50%

15.9

13.9 0.90 (0.63–1.29)

—

NSCLC: CheckMate 026 trial

EMA SPC links

2017-06-22

D.P. Carbone

First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer

Investigated (inv)

Comparator (comp)

Randomisation:

Primary tumour:

Subtype (biomarker):

Stage:

Line of therapy:

Primary

NIVO

PCT

HR

p

PFS

4.2 mo

5.9 mo

1.15 (0.91-1.45)

0.25

OS

—

—

—

—

Secondaries

NIVO

PCT

HR

p

OS

14.4 mo

13.2 mo

1.02 (0.80-1.30)

—

ORR (PD-L1≥5%)

26%

33%

1.43 (0.94-2.17)

—

DoR

12.1 mo

5.7 mo

—

—

Time to response

2.8 mo

2.6 mo

—

—

(all grades, %)

NIVO

PCT

p

Fatigue

21

35

NA

Diarrhea

14

13

NA

Nausea

12

48

NA

Rash

10

6

NA

Vomiting

6

23

NA

Anemia

3

43

NA