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Title: Immunotherapeutic Drug OvaRex Shows Promise in Delaying Ovarian Cancer Recurrence: Presented at SGO

"Immunotherapeutic Drug OvaRex Shows Promise in Delaying Ovarian Cancer Recurrence: Presented at SGO"

By Bonnie Darves SAN DIEGO, CA -- February 13, 2004 -- Results of a multicentre prospective phase 2 study of the MAb drug oregovomab (OvaRex) suggest that the agent, being investigated as an immunotherapeutic in consolidation therapy, may delay disease recurrence in ovarian cancer patients. Although many patients with advanced ovarian cancer respond well to chemotherapy, relapse is common, and immunosuppression-related complications and toxicity may prevent patients from continuing chemotherapy. As a result, researchers are investigating the use of non-toxic drugs that might help preserve immune function during the critical treatment period when the disease has been controlled. Results of the study were presented here February 10th at the Annual Meeting of the Society of Gynecologic Oncologists. In the randomised study, 67 patients with Stage III or IV cancer who had undergone tumor resection surgery and had responded well to initial chemotherapy, received either oregovomab (OV) or placebo intravenously at four, eight, and 12 weeks – and then quarterly until relapse – following three cycles of chemotherapy. Subjects who received OV after frontline therapy relapsed a mean of 24 months after therapy, compared with 10.8 months for patients who received placebo. Adverse events were similar for both groups, and quality of life analysis showed no significant difference between the treated group and controls, indicating that OV has a favourable toxicity profile, researchers noted. Based on these results, OV appears to provide significant clinical benefit to patients who respond to chemotherapy, according to lead investigator Jonathan Berek, MD, of the David Geffen School of Medicine at UCLA, in Los Angeles. He noted that the study's findings are being confirmed in a phase 3 study currently underway at more than 70 centres in the U.S. [Study title: Randomized Prospective Study of OvaRex MAb for Consolidation of Clinical Remission in Patients With Ovarian Cancer: Prolonged Disease-Free Survival in Optimal Chemosensitive Patients. Poster 4]

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