Nektar Therapeutics Announces Positive Topline Results for NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian Cancer
Press Release Source: Nektar Therapeutics On Tuesday January 12, 2010, 9:00 am
SAN CARLOS, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced preliminary results from the first stage of a two-stage Phase 2 clinical study evaluating NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients enrolled with platinum-resistant disease were evaluable 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(1). The first stage of the NKTR-102 Phase 2 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 each dose schedule, respectively. The Phase 2 study has now completed enrollment with a total of 71 patients. Approximately one-third of the patients in the study remain on NKTR-102 treatment, including a number of patients in the first stage of the study.
"The early and dramatic reductions in CA-125 in many of the patients with platinum-resistant and refractory ovarian cancer indicate that NKTR-102 has great therapeutic potential," said Prof. Dr. Ignace Vergote, Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union and Lead Investigator of the NKTR-102 study. "NKTR-102 is one of the most promising agents for platinum-resistant ovarian cancer I have seen in 25 years, as evidenced by the number of women in the study with tumor response and rapid biochemical response. This drug warrants further definitive Phase 3 testing as quickly as possible. The investigators look forward to presenting the final data at an upcoming scientific meeting."
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%).
"This population of heavily pre-treated patients, which includes a high proportion of women with platinum-refractory disease, is among the most challenging to treat in oncology," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer. "Almost half of the patients in the first stage of our study had platinum-refractory disease, having progressed within three weeks of their last platinum regimen. We are highly encouraged by the compelling efficacy seen to-date in the patients from the first stage of our study. This efficacy is accompanied by a favorable safety profile with regard to both GI side effects and neutropenia."
About the Study
The Phase 2 study is evaluating two dose regimens (q14 day and q21 day) of single-agent NKTR-102 in women with platinum-resistant ovarian cancer. The study employs a two-stage design, with 41 patients in the first stage and 30 patients in the second stage. Two patients in the q14 day dose regimen in the first stage had platinum-sensitive disease and were not evaluable for the primary outcome measure. 44% of the patients in the first stage were platinum-refractory, having progressed within three weeks of their last platinum therapy. 77% of the patients in the first stage had a platinum-free interval of less than three months (progression within three months of last platinum therapy). Secondary endpoints of the Phase 2 study include progression-free survival and safety.
CA-125 is a biochemical marker that is found in the blood of ovarian cancer patients and is measured to assess disease progression and recurrence. RECIST classifies response based upon tumor reduction measured by imaging methods.
Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system(2). Agents currently approved by the U.S. Food & Drug Administration to treat women with platinum-resistant ovarian cancer have modest overall response rates of between 6.5 to 13.8%(3,4).
About NKTR-102
Nektar is developing NKTR-102, a topoisomerase I inhibitor-polymer conjugate with reduced peak concentrations and a continuous concentration profile. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform.
In addition to the fully-enrolled Phase 2 study currently underway in platinum-resistant ovarian cancer, NKTR-102 is also being tested in two separate Phase 2 clinical trials in patients with metastatic breast cancer and second-line colorectal cancer.
The company also announced today that it has opened the second stage of its Phase 2 study of NKTR-102 in women with metastatic breast cancer evaluating two dose regimens (q14 and q21 day dose schedules). Enrollment of the first stage of this two-stage study is complete for both regimens (20 patients per regimen).
surf's up......crikey
