NKTR-102 Shows High Response Rate and Sustained Duration of Response in Women with Platinum-Resistant/Refractory Ovarian Cancer Previously Treated with DoxilÃ‚®
CHICAGO, June 5, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR ) today announced positive results from a subpopulation of patients in a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. A total of 33 women in the study with prior Doxil® (pegylated liposomal doxorubicin or PLD) treatment were evaluable for response rate using either RECIST 1.0 criteria (response by tumor imaging) or Gynecologic Cancer InterGroup (GCIG) criteria, which is a combination of RECIST and/or ovarian cancer biomarker (CA-125) criteria.(1) Confirmed and unconfirmed objective response rates using RECIST were 25 percent (4/16) and 29 percent (4/14) for the q14d and q21d dose schedules, respectively. Confirmed objective response rates using RECIST were 19 percent (3/16) and 21 percent (3/14) for each dose schedule, respectively. GCIG (confirmed and unconfirmed) response rates were 50 percent (8/16) in the once every 14 days (q14d) dose schedule and 35 percent (6/17) for the once every 21 days (q21d) dose schedule. Confirmed objective GCIG response rates were 38 percent (6/16) and 35 percent (6/17) in the q14d and q21d dose schedules, respectively.
Median progression-free survival for all 33 patients in the subpopulation previously treated with PLD was 5.4 months and median overall survival was 13.9 months. The median duration of confirmed response was 4.2 months in the q14d schedule and 4.4 months in the q21d schedule.
"NKTR-102 exhibits an exceptionally high response rate and long median survival compared to what would be expected in this group of heavily pre-treated women with platinum-resistant and refractory ovarian cancer," said Dr. Agustin Garcia, Associate Professor of Clinical Medicine at USC Norris Comprehensive Center. "Women whose cancer has progressed following trea