Biopharmaceutical company Nektar Therapeutics has commenced a Phase II study evaluating etirinotecan pegol (NKTR-102) as a third-line treatment for patients with metastatic and recurrent non-small cell lung cancer (NSCLC).
Etirinotecan pegol is a targeted topoisomerase I inhibitor designed for prolonged tumor cell exposure.
Around 37 patients are expected to be enrolled in the study, which is being conducted at the Abramson Cancer Center of the University of Pennsylvania.
Abramson Cancer Center assistant professor of oncology Dr Charu Aggarwal said at present there are no standard treatment options for patients with metastatic or recurrent non-small cell lung cancer after the failure of second-line treatment.
"In Phase I studies, etirinotecan pegol demonstrated encouraging anti-tumor activity in a broad range of solid tumors including non-small cell lung cancer," Aggarwal said.
Patients in the open-label, single-arm trial will be administered with etirinotecan pegol once every three weeks as monotherapy.
The primary endpoint of the Phase II study is overall response rate (ORR) while secondary endpoints include progression free survival (PFS), overall survival (OS), median duration of response (DoR) and the safety profile of etirinotecan pegol in patients with NSCLC after failure of second-line therapy.
Nektar Therapeutics senior vice president and chief medical officer Dr Robert Medve said the oncology community is interested in etirinotecan pegol.
"The results of these studies will provide us with a greater understanding of the potential of etirinotecan pegol to benefit patients in need of new treatment options," Medve said.