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ZZ.PI > PI > Flashcards

PI Flashcards

1
Q

Accelerated approval based on?

A

ORR and DoR

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2
Q

Reduce risk of Extravasation by?

A

Central Venous Catheter

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3
Q

Grade 3/4 Neutropenia?

A

41% patients

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4
Q

Median time onset Grade 3/4 Neutropenia?

A

15 days

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5
Q

Median Duration of Neutropenia?

A

7 days

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6
Q

Febrile Neutropenia

A

7% Patients

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7
Q

Sepsis?

A

2%

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8
Q

Grade 3/4 Thrombocytopenia

A

10%

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9
Q

Median time to onset thrombocytopenia?

A

10 days

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10
Q

Median Duration of thrombocytopenia?

A

7 days

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11
Q

Grade 3/4 Anemia

A

17% patients

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12
Q

Dose interruptions due to adverse reaction?

A

30.5%

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13
Q

Dose reductions due to AE?

A

25% patients.

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14
Q

Molecular Formula

A

C41H44N4O10S

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15
Q

Molecular Wt

A

784.87 g/mol

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16
Q

Terminal Half life

A

51 Hours

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17
Q

Major efficacy outcome measure?

A

Confirmed IA ORR

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18
Q

Additional efficacy outcome measures?

A

DoR and an IRC assessed ORR using RECIST 1.1

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19
Q

Prior radiotherapy?

A

71%

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20
Q

IRC ORR?

A

30%

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21
Q

IRC CTFI<90 ORR?

A

13%

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22
Q

IRC ORR CTFI>90

A

43%

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23
Q

Secondary endpoint?

A

PFS+OS

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24
Q

Median Follow up PFS and OS?

A

17.1 mos

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25
Q

Time from date of first infusion to disease progression or death from any cause?

A

PFS

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26
Q

Date of first infusion to death or loss of follow up?

A

OS

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27
Q

Data cut off?

A

Jan 15, 2019

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28
Q

2.6 months?

A

IA CTFI<90 median PFS

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29
Q

1.4 mos

A

CTFI <90, Median PFS IRC

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30
Q

4.6 mos

A

CTFI >90, median PFS, IA

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31
Q

4.3 mos

A

CTFI >90 days, Median PFS, IRC

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32
Q

9.3 mos

A

Median OS

33
Q

3.5 mos

A

Median PFS IA and IRC

34
Q

5.0 months

A

Median OS , CTFI <90

35
Q

11.9mos

A

Median OS, CTFI >90

36
Q

69%

A

DCR IA

37
Q

62%

A

DCR IRC

38
Q

5.3 mos

A

DoR IA

39
Q

5.1 mos

A

DoR
IRC

40
Q

62%

A

IA DCR CTFI <30

41
Q

42%

A

IA DCR CTFI 30 to <90

42
Q

75%

A

IA DCR 90 to <180

43
Q

95%

A

IA DCR CTFI >180

44
Q

48%

A

IRC DCR CTFI <30

45
Q

46%

A

IRC DCR 30 to <90

46
Q

70%

A

IRC DCR CTFI 90 to <180

47
Q

80%

A

IRC DCR CTFI > 180

48
Q

5.5 months by IA and IRC

A

DoR in >180 day subgroup (n=20)

49
Q

95%

A

In an exploratory analysis, DCR in patients with CTFI >180 days, by IA

50
Q

80%

A

In an exploratory analysis, DCR in patients >180 days by IRC

51
Q

6.2 months Median DoR IA
5.3 months Median DoR IRC

A

Patients with CTFI 90 to <180 days

52
Q

75% DCR IA
70% DCR IRC

A

Patients with CTFI 90 and <180 days (40 patients)

53
Q

38% IA/40% IRC

A

ORR in patients 90 to <180 days CTFI

54
Q

29% ORR IA/17% ORR IRC

A

CTFI 90 and <180, n=24

55
Q

42% IA DCR, 46% IRC DCR

A

CTFI 30 to <90
n=24

56
Q

Exploratory endpoints

A

DCR

57
Q

4.1 month Median DoR IA, 4.5 month Median DoR IRC

A

CTFI 30 to <90 days n=24

58
Q

14%, 10%

A

ORR CTFI <30 days n=21

59
Q

62%, 48%

A

DCR, IA and IRC CTFI <30 n=21

60
Q

7.1 mo, 5.1 mo

A

Median DoR IA, IRC CTFI <30 n=21

61
Q

12% Grade 3/4

A

Fatigue

62
Q

Alopecia

A

1%

63
Q

Adverse reactions resulting in permanent discontinuation in >1% patients included

A

Peripheral neuropathy and Myelosuppression

64
Q

Permanent Discontinuation

A

1.9%

65
Q

Adverse reactions requiring dosage reduction in >3% patients included

A

Neutropenia
Febrile Neutropenia
Fatigue

66
Q

AE requiring dosage interruptions in >3% patients

A

Neutropenia
Hypoalbuminemia

67
Q

Most AE’s were

A

Grade 1/2

68
Q

14%

A

ORR, IA, CTFI<30

69
Q

29%

A

ORR by IA in 30 to <90 CTFI

70
Q

38%

A

ORR by IA in CTFI 90 to <180

71
Q

60%

A

ORR by IA in CTFI >180

72
Q

10%

A

ORR IRC CTFI <30

73
Q

17%

A

ORR by IRC in 30 to <90 day CTFI

74
Q

40%

A

ORR by IRC in 90 to <180 CTFI

75
Q

50%

A

ORR by IRC >180 day CTFI

76
Q

Exploratory Analysis results not powered

A

ORR

77
Q

In the overall population ______ patients achieved ORR by IA

A

> 1 in 3 patients

78
Q

Additional endpoints

A

PFS, OS

ZZ.PI (6 decks)

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