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Studies in mHSPC: what patient populations

were included?

ADT+AA+P vs ADT

ADT+Doc vs ADT

LATITUDE*

1

STAMPEDE

(Arm G)

2,3

GETUG-AFU 15

4

CHAARTED

5,6

STAMPEDE

(Arm C)

7

Total sample size, n

1199

1917

385

790

1776

Patients with mHSPC

100%

52%

100%

100%

61%

Patients with high-

risk/high volume mHSPC 100%

NE

47.5% (183)

65 % (513)

NE

Patients with

de novo

M1 100%

49%

71%

72.8%

58%

Patients with visceral

metastasis

17.3%

3%

14.5%

15.6%

3.8%

Patients with Gleason

Score ≥8

98%

74.9%

56.1%

61.3%

70.1%

Not head-to-head comparison studies

* All LATITUDE patients had high-risk and newly diagnosed metastatic disease

NE, not evaluated

1

Fizazi K et al. N Engl J Med 2017;377(4):352-360;

2

James N et al. J Clin Oncol 2017;35(15):LBA5003;

3

James N et al. N Engl J Med 2017;377(4):338-351;

4

Gravis G et al.

Eur Urol 2016;70(2):256-62;

5

Sweeney C et al. N Engl J Med 2015;378(8):737-746;

6

Sweeney C et al. Ann Oncol 2016;27(suppl 6):720PD;

7

James N et al. Lancet 2016;387(10024):1163-77

HIGH RISK (HR)

1

At least 2 of 3:

≥3 bone lesions

Visceral metastasis

Gleason score ≥8

HIGH VOLUME (HV)

4,5

At least 1 of 2:

≥4 bone lesions with

≥1 beyond the

vertebral bodies/pelvis

Visceral metastasis

Studies in mHSPC: what patient populations

were included?

ADT+AA+P vs ADT

ADT+Doc vs ADT

LATITUDE*

1

STAMPEDE

(Arm G)

2,3

GETUG-AFU 15

4

CHAARTED

5,6

STAMPED

(Arm C)

7

Total sample size, n

1199

1917

385

790

1776

Patients with mHSPC

100%

52%

100%

100%

61%

Patients with high-

risk/high volume mHSPC 100%

NE

47.5% (183)

65 % (513)

NE

Patients with

de novo

M1 100%

49%

71%

72.8%

58%

Patients with visceral

metastasis

17.3%

3%

14.5%

15.6%

3.8%

Patients with Gleason

Score ≥8

98%

74.9%

56.1%

61.3%

70.1%

Not head-to-head comparison st

* All LATITUDE patients had high-risk and newly diagnosed metastatic disease

NE, not evaluated

1

Fizazi K et al. N Engl J Med 2017;377(4):352-360;

2

James N et al. J Clin Oncol 2017;35(15):LBA5003;

3

James N et al. N Engl J Med 2017;377(4):338-351;

4

Gra

Eur Urol 2016;70(2):256-62;

5

Sweeney C et al. N Engl J Med 2015;378(8):737-746;

6

Sweeney C et al. Ann Oncol 2016;27(suppl

7

James N et al. Lancet 2016;387(1002

HIGH RISK (HR)

1

At least 2 of 3:

≥3 bone lesions

Visceral metastasis

Gleason score ≥8

HIGH VOLUME (HV)

4,5

At least 1 of 2:

≥4 bone lesions with

≥1 beyond the

vertebral bodies/pelvis

Visceral metastasis