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Randomized, Placebo-Controlled Study of Oregovomab for Consolidation of Clinical Remission in Patients With Advanced Ovarian Cancer

From the David Geffen School of Medicine at UCLA, University of California at Los Angeles, CA; University of Virginia, Charlottesville, VA; US Oncology, Texas Oncology PA, Dallas, TX; State University of New York Upstate Medical University, Syracuse, NY; Florida Hospital Cancer Institute, Orlando; Florida Gynecologic Oncology, Ft Myers, FL; Swedish Tumor Institute, Seattle, WA; Unither Pharmaceuticals, Wellesley Hills, MA; and University of Pittsburgh, Pittsburgh, PA

Address reprint requests to Jonathan S. Berek, MD, MMSc, David Geffen School of Medicine at UCLA, University of California at Los Angeles, Division of Gynecologic Oncology, 24-137 UCLA Center for the Health Sciences, 10833 Le Conte Ave, Los Angeles, CA 90095-1740; e-mail: jberek{at}mednet.ucla.edu

PURPOSE: To assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunotherapeutic strategy for subsequent study.

PATIENTS AND METHODS: Patients with stage III/IV ovarian cancer who had a complete clinical response to primary treatment were randomly assigned to oregovomab or placebo administered at weeks 0, 4, and 8, and every 12 weeks up to 2 years or until recurrence. The primary end-point was time to relapse (TTR).

RESULTS: One hundred forty-five patients were treated with oregovomab (n = 73) or placebo (n = 72). For the population overall, median TTR was not different between treatments at 13.3 months for oregovomab and 10.3 months for placebo (P = .71). Immune responses were induced in most actively treated patients. This was associated with prolonged TTR. Quality of life was not adversely impacted by treatment. Adverse events were reported with similar frequency in oregovomab and placebo groups, indicating a benign safety profile. A long-term survival follow-up is ongoing. Cox analysis of relapse data identified significant factors: performance status, CA-125 before third cycle, and baseline CA-125. Further evaluation identified a subpopulation with favorable prognostic indicators designated as the successful front-line therapy (SFLT) population. For the SFLT population, TTR was 24.0 months in the oregovomab group compared with 10.8 months for placebo (unadjusted hazard ratio of 0.543 [95% CI, 0.287 to 1.025]), a hypothesis-generating observation.

CONCLUSION: Consolidation therapy with oregovomab did not significantly improve TTR overall. A set of confirmatory phase III studies has been initiated to determine whether the SFLT population derives benefit from oregovomab treatment.

Supported by AltaRex Corp, Edmonton, Alberta, Canada, and United Therapeutics Corp, Silver Spring, MD.

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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