Nektar Presents Positive Clinical Data From Phase 1 Study Of Etirinotecan Pegol

(RTTNews) - Nektar Therapeutics (NKTR) said Saturday that it presented favorable data from a Phase 1 study of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin or LV in patients with advanced cancer.

NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle, and to reduce the peak exposures that are associated with toxicities of other cytotoxics. These new data were presented at the 2014 Gastrointestinal Cancers Symposium in San Francisco, California.

The phase 1 study assessed the safety, pharmacokinetics and anti-tumor activity of NKTR-102 when given in combination with standard doses of 5-FU/leucovorin. Data was presented from 26 patients enrolled in 5 cohorts in a standard dose escalation design.

The study established a recommended dose of 75 mg/m2 NKTR-102 in combination with standard doses of 5-FU/LV given every two weeks. Promising clinical activity, including objective response (2 patients), clinical benefit (stable disease>=6 months; 10 patients) and clinically significant declines in tumor markers were observed (including a patient with pancreatic cancer whose disease had progressed on prior irinotecan). Toxicities of diarrhea and reversible neutropenia were generally manageable with dose delays and reductions.

NKTR-102 is a new potential therapeutic option in development for advanced breast cancer. It is the first long-acting topoisomerase I-inhibitor with a non-overlapping mechanism of action with other agents used to treat breast cancer, which may mitigate potential cancer cross-resistance and reduce overlapping toxicities.

In November 2012, NKTR-102 was designated a Fast Track development program by the U.S. FDA for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with ATC.