FDA has expanded the indication of pomalidomide (Pomalyst) to include adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, and Kaposi sarcoma in adult patients who are HIV-negative.
Pomalyst is sponsored by Celgene Corp.
Efficacy was investigated in Study 12-C-0047, an open-label, single-arm clinical trial, conducted by NCI. Twenty-eight patients (18 HIV-positive, 10 HIV-negative) received 5 mg of pomalidomide orally once daily on days 1 through 21 of each 28-day cycle until disease progression or unacceptable toxicity. All HIV-positive patients continued highly active antiretroviral therapy.
The main efficacy outcome measure was overall response rate, which included complete response, clinical complete response, and partial response. Response was assessed by the investigator according to the AIDS Clinical Trial Group Oncology Committee response criteria for Kaposi sarcoma. Among the 18 HIV-positive patients, the ORR was 67% (95% CI: 41, 87) with a median response duration of 12.5 months (95% CI: 6.5, 24.9). Among the 10 HIV-negative patients, the ORR was 80% (95% CI: 44, 98) with a median response duration of 10.5 months (95% CI: 3.9, 24.2).