Summary
Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on December 5, 2011, reporting updates on two key drug candidates, ZALTRAP and EYLEA. Regarding ZALTRAP, Regeneron announced top-line results from the Phase 2 AFFIRM trial for metastatic colorectal cancer. While the primary endpoint of one-year Progression Free Survival (PFS) was similar between the ZALTRAP plus chemotherapy arm and the chemotherapy-alone arm, the study was not designed for direct statistical comparison, with the control arm serving as an internal benchmark. The safety profile of ZALTRAP was consistent with prior trials and other anti-VEGF agents. Separately, Regeneron and its collaborator Bayer HealthCare announced positive two-year Phase 3 results for EYLEA in wet age-related macular degeneration (AMD), indicating sustained improvement in visual acuity.
Key Highlights
- 1Regeneron announced top-line results from the Phase 2 AFFIRM trial for ZALTRAP in first-line metastatic colorectal cancer.
- 2The AFFIRM trial showed a similar one-year Progression Free Survival (PFS) rate between ZALTRAP + mFOLFOX6 and mFOLFOX6 alone, with the control arm used as an internal benchmark.
- 3The side effect profile of ZALTRAP in the AFFIRM trial was consistent with previous studies and other anti-VEGF agents.
- 4Sanofi has submitted a Biologics License Application (BLA) to the FDA for ZALTRAP in previously treated metastatic colorectal cancer patients.
- 5Regeneron and Bayer HealthCare announced two-year Phase 3 results for EYLEA in wet age-related macular degeneration (AMD).
- 6The Phase 3 VIEW 1 and VIEW 2 studies for EYLEA demonstrated sustained improvement in visual acuity over two years in wet AMD patients.