The FDA granted fast track designation to navicixizumab for the treatment of women with heavily pretreated high-grade ovarian, primary peritoneal or fallopian tube cancer.
The designation applies to use of navicixizumab (Mereo BioPharma) — an anti-Delta-like ligand 4/vascular endothelial growth factor bispecific antibody — for women who received at least three prior therapies and/or prior bevacizumab (Avastin, Genentech).
“We are pleased that the FDA continues to recognize the potential of navicixizumab to become a viable new treatment option for patients with platinum-resistant ovarian cancer who failed multiple other therapies,” Jill Henrich, senior vice president of regulatory affairs at Mereo BioPharma, said in a company-issued press release.
A phase 1a study assessed navicixizumab monotherapy for patients with various types of refractory solid tumors. Nineteen (28.7%) of 66 patients had tumor shrinkage after treatment, and 12 (25%) of the women with ovarian cancer treated on the trial achieved unconfirmed partial response.
An ongoing phase 1b study is designed to evaluate the agent in combination with paclitaxel for women with advanced heavily pretreated ovarian cancer. The study includes 44 women with platinum-resistant disease who failed more than two prior therapies and/or received prior bevacizumab.
An interim analysis performed earlier this year showed an unconfirmed response rate of 41%, with overall response rates of 64% for bevacizumab-naive women and 30% for those who received prior bevacizumab. Median PFS in the entire cohort was 7.3 months.
The most common any-grade related adverse events were hypertension (68%), fatigue (46%), headache (25%), neutropenia (21%), diarrhea (18%), pulmonary hypertension (14%), dyspnea (14%) and peripheral edema (14%). Other related adverse events of special interest included one grade 1 heart failure; two cases of thrombocytopenia, one grade 3 and one grade 4; and one grade 4 gastrointestinal perforation.
In July, the FDA agreed in principle on an outline for a phase 2 trial that could support accelerated approval of navicixizumab for women with ovarian cancer who developed resistance to previous therapies, Henrich said.