Citing problems with the number of patients recruited for a mid-stage clinical trial of the cancer drug aflibercept along with the fragile health of the patients involved, Regeneron Therapeutics and Sanofi-Aventis say they will not be presenting data from the study for accelerated approval. Those complicating factors, say researchers, makes it too difficult to judge the clinical efficacy of the drug for ovarian cancer.
The Phase II trial did produce a statistically significant improvement in the primary endpoint: removal of fluid from the abdominal cavity when compared to a placebo. Now Regeneron plans to focus on its late-stage work on the drug, testing it in combination with chemotherapy for metastatic colorectal, non-small cell lung, pancreatic, and prostate cancers.
"Given the small number of patients enrolled in this study and the fragile health status of these advanced ovarian cancer patients, who had a median survival of only about three to four months, it is difficult to definitively assess the overall clinical benefit that might be derived from treatment in the real-world clinical practice setting," said Dr. George D. Yancopoulos, president of Regeneron Research Laboratories, in a statement.
And on a separate note, Regeneron also reworked a collaboration deal with Novartis. The developer now stands to gain royalties for Novartis' canakinumab (ACZ885) being developed for inflammatory diseases and waives its rights to opt-in on the development and commercialization of the drug, an interleukin-IL1β antibody for cryopyrin-associated periodic syndrome.
- check out the Regeneron' srelease
- read the report from Reuters