Celgene announces results of REVLIMID, docetaxel/prednisone phase II combination study on mCRPC

Celgene International Sàrl (NASDAQ: CELG) today announced results from a phase II investigator initiated study of REVLIMID (lenalidomide) in combination with Avastin (bevacizumab), docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer were presented at the 2011 American Society of Clinical Oncology Annual Meeting in Chicago, Ill.

In the study, patients with chemotherapy naïve, progressive mCRPC were treated with docetaxel (75 mg/m2) and bevacizumab (15 mg/kg) on day one, plus lenalidomide (25 mg) on days 1-14, with daily prednisone (10 mg) and enoxaparin during each 21-day cycle.

At the time of presentation, 46 of the planned 51 patients were enrolled. The overall PSA response rate was 86.4% (38/44). More than 70 percent (31/44) of the patients on the trial had a reduction in PSA of at least 75%. Of 24 patients with measurable disease, the overall RECIST response rate was 87.5%, with one complete response, 20 partial responses and 3 patients with stable disease.

Grade 3 or higher toxicities in the study included neutropenia (39% 18/46), anemia (13% 6/46), infection (13% 6/46) and thrombocytopenia (9% 4/46). One patient had hypertension and two had febrile neutropenia. Two patients had perianal fistula. Osteonecrosis of the jaw occurred in 30% (14/46). Of these patients, nine had concomitant and four had a history of bisphosphonate use.

These results are from an investigational study. REVLIMID is not approved as a treatment for prostate cancer.

The combination of REVLIMID and docetaxel/prednisone for the initial treatment of patients with metastatic castration resistant prostate cancer is currently being evaluated in a pivotal Phase III trial (MAINSAIL).