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NKTR-102 Shows High Response Rate and Sustained Duration of Response in Women with Platinum-Resistant/Refractory Ovarian Cancer Previously Treated with Doxil®
Date:6/5/2011

4

4

4Previous Platinum Regimens  1

13%

35%

24%  2

56%

24%

39%  3

25%

18%

21%  4+

6%

24%

15%Prior bevacizumab

6%

24%

15%Prior gemcitabine

56%

59%

58%Prior taxane

100%

100%

100%TABLE 2. Efficacy Results: Objective Response Rates by RECIST and GCIG in Subpopulation Receiving Prior Treatment with PLDNKTR-102NKTR-102145 mg/m2  q14d145 mg/m2q21dRECISTN (evaluable)16

14Confirmed + Unconfirmed

4 (25%)

4 (29%)Confirmed

3 (19%)

3 (21%)Duration of Confirmed Response (months, range)

4.2 (3-14)

4.4 (3-9)GCIGN (evaluable)

16

17Confirmed + Unconfirmed

8 (50%)

6 (35%)Confirmed

6 (38%)

6 (35%)CA-125N (evaluable)

15

14Confirmed

6 (40%)

5 (36%)*Only patients with measurable disease/CA-125 at baseline were considered evaluable.TABLE 3. Safety Results in Subpopulation Receiving Prior Treatment with PLDMost Common Drug-related Grade 3 and 4

Adverse Events > 5% or event of interest

N (%) NKTR-102

145 mg/m2

q14d

N=16

NKTR-102

145 mg/m2

q21d

N=17Grade 3

Grade 4

Grade 3

Grade 4Diarrhea

5 (31%)

0

3 (18%)

0Hypokalemia

5 (31%)

1 (6%)

0

0Nausea

5 (31%)

0

1 (6%)

0Dehydration

3 (19%)

0

1 (6%)

0Fatigue

1 (6%)

0

3 (18%)

0Vomiting

4 (25%)

0

0

0Neutropenia

1 (6%)

0

1 (6%)

1 (6%)Anaemia

2 (12.5%)

0

0

0Decreased appetite

1 (6%)

0

1 (6%)

0Hyponatraemia

2 (13%)

0

0

0Lymphophenia

1 (6%)

0

1 (6%)

0Note: There wa
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SOURCE Nektar Therapeutics
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3. FDA Grants Orphan Drug Designation for Nektars Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer
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