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Etirinotecan pegol active in platinum-resistant ovarian cancer
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Two different dosing regimens of single-agent etirinotecan pegol were associated with encouraging response rates, OS and PFS in patients with platinum-resistant ovarian cancer, according to results of a randomized phase 2 study.
Etirinotecan pegol (NKTR-102, Nektar Therapeutics) is a long-acting topoisomerase-I inhibitor with prolonged systemic exposure to 7-ethyl-10-hydroxycamptothecin, the active metabolite of irinotecan, according to background information in the study.
Ignace B. Vergote, MD, PhD, of the division of gynecologic oncology at University Hospitals — KU Leuven in Belgium, and colleagues evaluated two dosing schedules of etirinotecan pegol in 71 patients with platinum-resistant/refractory ovarian carcinoma. Patients had undergone a median three prior therapies.
Researchers randomly assigned 36 patients to receive 145 mg/m2 etirinotecan pegol every 14 days. The other 35 patients received 145 mg/m2 every 21 days. Treatment continued until disease progression or serious adverse events.
Researchers reported a median overall response rate of 20% (95% CI, 10.0-30.0). Median duration of response was 4.1 months among those treated every 14 days vs. 4 months for those treated every 21 days. However, researchers reported longer median PFS (5.3 months vs. 4.1 months) and median OS (11.7 months vs. 10 months) among those treated every 21 days.
Researchers said etirinotecan pegol was well tolerated. The most common grade 3 and grade 4 adverse events were dehydration (24%) and diarrhea (23%). Diarrhea, dehydration, nausea and neutropenia were more common in the 14-day treatment group.
“The treatment schedule of etirinotecan pegol 145 mg/m2 once every 21 days was selected for the expanded phase 2 study and is preferred for future phase 3 studies,” Vergote and colleagues wrote. “These findings provide support to directly compare etirinotecan pegol versus one of the approved drugs (pegylated liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer.”
Disclosure: The researchers report employment or leadership positions with, consultant/advisory roles with, and research funding and honoraria from Nektar Therapeutics.
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