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Phase 3 Trial Of ZALTRAP™ (aflibercept) In Advanced Prostate Cancer To Continue As Planned At Recommendation Of Independent Data Monitoring Committee

Sanofi Oncology and Regeneron are collaborating on an oncology development program, combining the investigational agent ZALTRAP™ (aflibercept) with common chemotherapy regimens in the treatment of patients with advanced cancers.  In addition to VENICE, the program includes one Phase 3 trial and one Phase 2 trial:

  • VELOUR study (Phase 3): second-line treatment in combination with the FOLFIRI regimen (irinotecan-5-fluorouracil-leucovorin) in patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-based regimen.  Positive results demonstrating significantly improved survival with ZALTRAP were presented June 25 during the ESMO World Congress on Gastrointestinal Cancer; the associated abstract (#0-0024) was published in the June 2011 supplement to Annals of Oncology.
  • AFFIRM study (Phase 2): first-line treatment in mCRC in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin (FOLFOX).  Results are anticipated in the second half of 2011.

About Prostate Cancer

Worldwide, prostate cancer ranks second in cancer incidence, with approximately 900,000 new cases annually, and sixth in cancer mortality in men.(2)  Latest figures show that an estimated 324,000 new cases of prostate cancer appear in the European Union every year.(3)  In the U.S., prostate cancer is the leading cause of cancer in men and remains the second most common cause of cancer death among men after lung cancer.(4) The American Cancer Society estimates that in 2011 in the U.S., there will be 241,000 new cases of prostate cancer and 34,000 prostate cancer deaths.(4)  For many patients with prostate cancer, their disease continues to progress despite prior treatment – including surgical and/or hormonal castration followed by chemotherapy.  Metastatic prostate cancer indicates that the cancer has spread to the lymph nodes or other parts of the body, particularly the bones.  Castration resistant/hormone-refractory prostate cancer means that the cancer has continued to grow despite the suppression of male hormones that fuel the growth of prostate cancer cells.  An estimated 10-20% of patients with prostate cancer are diagnosed when the cancer has already metastasized.(5)

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