Phase III MORAb-003-004 trial data of MORAb 003 (farletuzumab) fails to meet PFS endpoints in ovarian cancer- Morphotek

Morphotek has announced results from the Phase III MORAb-003-004 trial of MORAb-003 (farletuzumab) in Ovarian Cancer were recently published in the Journal of Clinical Oncology. The MORAb-003-004 clinical trial (also known as FAR-131) was a randomized, double-blind, placebo-controlled, Phase III, global study of the safety and efficacy of weekly farletuzumab (MORAb-003) in combination with a platinum standard chemotherapy regimen (carboplatin plus taxane) in platinum-sensitive ovarian cancer patients in first relapse. All subjects received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomized test product 1:1:1 farletuzumab 1.25 mg/kg, farletuzumab 2.5 mg/kg, or placebo), and single-agent test product was continued weekly until disease progression.

Neither farletuzumab dose met the study's primary progression-free survival (PFS) endpoint when compared to placebo, with PFS of 9.0, 9.5 and 9.7 months for the placebo, farletuzumab 1.25 mg/kg, and farletuzumab 2.5 mg/kg arms, respectively. There was no difference in overall survival. Prespecified subgroup analyses demonstrated that subjects with a low CA125 level (less than three times the upper limit of normal) correlated with longer PFS and OS for farletuzumab 2.5 mg/kg versus placebo. Subjects with higher farletuzumab exposure also showed superior PFS and OS compared to placebo. CA125 is a tumor-produced protein elevated in the blood of some ovarian cancer patients that has been previously reported to reduce natural killer (NK) cell function; therefore, higher CA125 levels may interfere with the immune response associated with farletuzumab's potential activity. The most common adverse events were those known to be associated with chemotherapy, including: alopecia; nausea; neutropenia; fatigue; thrombocytopenia; and neuropathy.