Main > A1. CORP. INDEX. R-Rm > Regeneron Pharmaceuticals/P C2 > 2008. 05.21.2008. Onco.>Ovarian C.
- Aflibercept (VEGF Trap)
- Partner: Sanofi Aventis
Phase 2 Study of Single-Agent Aflibercept in Advanced Ovarian Cancer
The companies reported results of a randomized, double-blind, Phase 2 study of 215 women with advanced ovarian cancer who were treated with aflibercept at a dose of either 2 milligrams per kilogram (mg/kg) or 4 mg/kg every two weeks. Response to treatment was assessed both by the clinical investigators and an independent review committee (IRC). As assessed by the investigators, RECIST (Response Evaluation Criteria in Solid Tumors) response rates were 7.3 percent with the 4 mg/kg dose and 3.8 percent with the 2 mg/kg dose. As assessed by the IRC, patients achieved a response rate according to RECIST criteria of 4.6 percent in the 4 mg/kg arm and 0.9 percent in the 2 mg/kg arm. The study did not achieve its primary endpoint of demonstrating that patients in either arm of the study achieved a RECIST response rate as assessed by the IRC that was statistically significantly greater than 5 percent. The results were consistent with the interim data of the same trial reported at the 2007 ASCO meeting.
CA-125 response, an important marker of disease activity in ovarian cancer, was a key secondary endpoint of the study. Response rates, defined as at least a 50 percent reduction in CA-125 protein levels, were 11.6 percent in the evaluable patients treated with 4 mg/kg and 11.5 percent in the evaluable patients treated with 2 mg/kg. Eighteen (13.8 percent) of the 130 patients evaluable for CA-125 response from the combined groups had either a RECIST (as assessed by the IRC) or CA-125 response.
In the entire study population, as assessed by the IRC, median progression-free survival was 13.3 and 13.0 weeks with the 4 mg/kg and 2 mg/kg doses, respectively. Median overall survival was 49.3 and 55.4 weeks with the 4 mg/kg and 2 mg/kg doses, respectively.
Of the 40 patients in both dose groups who had evaluable ascites at baseline, 77.5 percent had either a complete disappearance or stabilization of their ascites over the study period, as assessed by the investigators.
Side effects of treatment with aflibercept were typical of this class of anti-angiogenic agents, with hypertension being the most common grade 3/4 adverse event. Other grade 3/4 adverse events occurring in at least 5 percent of patients included abdominal pain, anorexia, arthralgia, asthenia, diarrhrea, dysphonia, fatigue, headache, proteinuria, and vomiting. Bowel perforations were observed in 1.8 percent of patients. There were no significant differences in safety between the dose groups.
"We are encouraged by the results reported with the use of single-agent aflibercept in this advanced ovarian cancer patient population for whom few therapeutic options are available," stated Dr. Marc Cluzel, Senior Vice President, R&D of sanofi-aventis.
"We and sanofi-aventis are continuing to evaluate the data from this trial in order to determine the next steps for aflibercept in advanced ovarian cancer," commented George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories
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