US-based biopharmaceutical firm Nektar Therapeutics has reported positive data from a Phase I clinical trial of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV) for the treatment of patients with advanced cancer.

NKTR-102 is designed to concentrate in tumour tissue, provide sustained tumour suppression across the complete chemotherapy cycle as well as to reduce the peak exposures that are related with toxicities of other cytotoxics.

In the Phase I trial, safety, pharmacokinetics and anti-tumour activity of NKTR-102 were evaluated when administered in combination with standard doses of 5-FU/leucovorin.

The data was secured from 26 patients enrolled in five groups in the trial in a standard dose escalation design.

University of Arizona College of Medicine clinical professor of medicine and a principal investigator of the trial Dr Ramesh Ramanathan said that topoisomerase I inhibition combined with 5-fluorouracil (5-FU) and leucovorin (LV) remains one of the most active combinations used in advanced colorectal cancer.

"NKTR-102, a long-acting topoisomerase I-inhibitor, was safely combined with 5-FU/LV, and showed signs of clinical benefit including both objective responses and tumour marker reductions," Ramanathan added.

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"Continued development using this promising long-acting topoisomerase combination therapy is warranted, especially in clinical trials for advanced gastrointestinal malignancies."

The company said that the trial established a recommended dose of 75mg/m2 NKTR-102 in combination with standard doses of 5-FU/LV given every two weeks.

In the trial, promising clinical activity, including objective response, clinical benefit and clinically significant declines in tumour markers were observed, while toxicities of diarrhea and reversible neutropenia were generally manageable with dose delays and reductions.

According to the company, NKTR-102 is being developed for the treatment of advanced breast cancer, which may mitigate potential cancer cross-resistance and reduce overlapping toxicities.

Image: NKTR-102 is a new potential therapeutic option in development for advanced breast cancer. Photo courtesy of dream designs on