Recently, the oncology pipeline at Regeneron Pharmaceuticals Inc. (REGN) suffered a setback with its candidate aflibercept (VEGF Trap) failing in a late-stage study (VITAL; n= 913). The study evaluated the candidate as a second-line therapy for treating patients suffering from non-small cell lung cancer (NSCLC).
The candidate is being co-developed with Sanofi-Aventis (SNY). Regeneron intends to present complete data from the study at an upcoming medical meeting.
Results from the multinational, randomized, double-blind study revealed that treatment with aflibercept in conjunction with Sanofi’s cancer drug, Taxotere (docetaxel), did not improve overall survival in lung-cancer patients compared to the combination of Taxotere and placebo. The study evaluated patients suffering from NSCLC who did not respond favorably to a platinum-based therapy.
We note that the candidate is also being evaluated in late-stage studies as a second-line therapy for metastatic colorectal cancer (VELOUR study) and as a first-line treatment of hormone-refractory metastatic prostate cancer (VENICE study). Moreover, aflibercept is also being evaluated in a mid-stage study (AFFIRM) as a first-line therapy for patients suffering from metastatic colorectal cancer.
Complete data from the VELOUR study is expected in the first half of 2011.Regeneron expects results from the AFFIRM study in the second half of the current year. The independent data monitoring committee (IDMC) is expected to conduct an interim analysis of the data from the VENICE study in mid-2011 with complete results expected in 2012.
The co-developers will be hoping for positive results from the above studies following the disappointing data from the VITAL study. Regeneron and Sanofi will be banking on these results which will determine the candidate’s future in oncology.
Our Recommendation
Currently, we have a “Neutral” stance on Regeneron in the long run, which is supported by the Zacks #3 Rank (short-term “Hold” recommendation) carried by the company.
REGENERON PHARM (REGN): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
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