iCAD granted patent covering SecondLook Digital CAD solution incorporating lesion metrics
November 25, 2015
77% of the 39 women in the first stage of the NKTR-102 Phase 2 study had progressed within three months of their last platinum dose and 44% of patients in the first stage had actually progressed within three weeks of their last platinum regimen. There are patients in the first stage of the study still receiving treatment with NKTR-102.
In January, Nektar reported initial data from the first stage of the Phase 2 study for the primary endpoint of overall response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria.(2) Women in the first stage of the study showed an overall GCIG response rate of 32% (6/19) in the once every 14 days (q14 day) dose schedule and 35% (7/20) for the once every 21 days (q21 day) dose schedule. Confirmed objective response rates using RECIST were 21% (4/19) and 22% (4/18) for the q14 day and q21 day dose schedules, respectively. CA-125 response rates were 31% (5/16) and 38% (6/16), for the q14 day and q21 day dose schedules, respectively.
The most commonly observed grade 3 or grade 4 side effects in the study to date (every 14 day/every 21 day dose schedule) were diarrhea (29%/10%) and neutropenia (14%/10%).
The Phase 2 study has now completed enrollment with a total of 71 patients treated. The study is ongoing. Full data are expected to be presented at a major scientific conference in 2010.SOURCE Nektar Therapeutics