NKTR 102 (Nektar) update on cancer trials
Nektar Therapeutics announced the start of a Phase II study of NKTR 102 (etirinotecan pegol) in patients with bevacizumab (Avastin)-resistant high-grade Glioma being conducted at Stanford Cancer Institute. The primary endpoint of the Phase II study is the six-week progression free survival (PFS) rate. Secondary endpoints include survival from time of first etirinotecan pegol infusion, overall survival from date of pathologic diagnosis or confirmation of high-grade glioma, and the safety profile of etirinotecan pegol in patients with bevacizumab-resistant high-grade glioma. The open label, single-arm trial is expected to enroll approximately 20 patients who will receive etirinotecan pegol once every three weeks as monotherapy.
The BEACON study is a Phase III clinical study currently evaluating etirinotecan pegol for the treatment of metastatic breast cancer. In addition, etirinotecan pegol is also being tested as a single agent in a Phase II clinical trial in patients with platinum-refractory/resistant ovarian cancer, a Phase II clinical trial in patients with colorectal cancer with KRAS mutations after failing first- line therapy, and a Phase I clinical trial evaluating etirinotecan pegol in combination with 5-FU and leucovorin therapy.
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