Regeneron and development partner sanofi-aventis reported positive data from a Phase III trial evaluating Zaltrap™ (aflibercept or VEGF Trap), in combination with FOLFIRI chemotherapy as second-line treatment for metastatic colorectal cancer (mCRC). The Velour study enrolled 1,266 mCRC patients who had previously been treated with an oxaliplatin-based regimen. Results from the trial showed that in comparison with FOLFIRI plus placebo, the FOLFIRI-Zaltrap combination significantly boosted overall survival. The firms say they plan to submit for U.S. and European regulatory approval of Zaltrap in this indication during the second half of 2011.
The Velour study results are a contrast to those from the recently reported Phase III Vital trial. Topline data from Vital, announced last month, showed that adding aflibercept to chemotherapy in the second-line treatment of non-small-cell lung cancer (NSCLC) had no impact on overall survival compared with chemotherapy alone. However, the Vital study did find that the combination therapy improved progression-free survival compared with chemotherapy alone.
Zaltrap is fusion protein angiogenesis inhibitor designed to bind to VEGF-A, VEGF-B, and placental growth factor (PIGF) with higher affinity than their native receptors. Regeneron and sanofi-aventis are collaborating on a broad development program for the drug against late-stage cancers. Ongoing trials include the Phase III Venice study, which is evaluating Zaltrap in combination with docetaxel and prednisone as first-line treatment for hormone-refractory metastatic prostate cancer. Final data from Venice is expected during 2012. The Phase II Affirm study, meanwhile, is evaluating Zaltrap in combination with FOLFOX chemotherapy as first-line therapy for mCRC. Results from this trial are expected during the second half of 2011.
Regeneron has separately partnered with Bayer HealthCare for clinical development of an ophthalmic formulation of the aflibercept (VEGF Trap-Eye) for the treatment of eye disorders, including wet age-related macular degeneration (AMD), diabetic macular edema, and central retinal vein occlusion. In February Regeneron submitted a BLA to FDA for the use of VEGF Trap-Eye as a treatment for wet AMD. At the time it said Bayer HealthCare also expects to submit regulatory applications in Europe during the first half of this year.