Nektar initiates dosing in Phase II ovarian cancer trial

Regulatory approvals have also been obtained and dosing will begin shortly in two additional trials: a randomized Phase II study to evaluate NKTR-102 versus irinotecan in second-line colorectal cancer patients with the KRAS gene mutation, and a Phase II study in metastatic breast cancer. Nektar has also received institutional review board approval for a Phase II cervical cancer study of NKTR-102.

The NKTR-102 Phase II randomized trial will evaluate the efficacy and safety of NKTR-102 monotherapy versus irinotecan in second-line colorectal cancer patients with the KRAS mutant gene. The primary endpoint of this placebo-controlled trial will be a clinically meaningful improvement in progression-free survival as compared to standard irinotecan monotherapy. It is estimated that up to 45% of colorectal cancer cases have this mutation in the KRAS gene and do not respond to EGFR-inhibitors, such as cetuximab.

The NKTR-102 Phase II studies in ovarian, breast and cervical cancers will be open label, single arm studies encompassing two treatment regimens. Patients include those with metastatic breast cancer with prior taxane treatment, those with metastatic, platinum-resistant ovarian cancer and those with metastatic cervical cancer. The trials are designed to evaluate the overall response rate of NKTR-102 monotherapy in each tumor setting, with secondary endpoints including progression-free survival, safety and six- and 12-month overall survival.

Using its polymer conjugate technology platform, Nektar said that it is the first company to have created a small molecule PEGylated drug conjugate that has demonstrated therapeutic activity in patients. In addition to the Phase II clinical studies in breast, ovarian, cervical and colorectal cancers, a Phase IIa study evaluating NKTR-102 in combination with cetuximab has completed enrollment and full results of this study are expected to be available in the first half of 2009.

Randall Moreadith, chief development officer of Nektar, said: “We are excited to have dosed our first patient in the start of our expanded Phase II clinical development program. NKTR-102 is a novel oncolytic that has the potential to dramatically expand therapeutic options for oncologists and improve survival rates for patients with a variety of cancers.”