Quick Take: Assessment of the Safety of Pembrolizumab in Patients With HIV and Advanced Cancer—A Phase 1 Study

Immunotherapies such as anti-PD-1 (anti-programmed cell death 1) and anti-PD-L1 (anti-programmed cell death ligand 1) are effective in treating numerous malignancies. The safety and efficacy in patients who have both cancer and HIV, however, has not been well studied. In this non-randomized open-label trial, investigators treated 30 participants with advanced cancer and HIV with the anti-PD-1 monoclonal antibody pembrolizumab in order to study the safety and tolerability of the therapy. Patients with HIV were treated with anti-retroviral therapy and had a CD4+ T-cell count greater than 100 cells/μL. Investigators found that most adverse events at least possibly attributed to pembrolizumab were grade 1 or 2 (22 events), and 20% were grade 3 (6 events). One participant died after developing a polyclonal Kaposi sarcoma (KS) herpesvirus-associated B-cell lymphoproliferation; this participant had pretreatment KS herpesvirus. In terms of response to pembrolizumab, investigators found that half of the 30 patients had stable disease for less than 24 weeks, 1 patient had a complete response, 2 patients had a partial response, and 8 patients had progressive disease. The complete response was seen in a patient with lung cancer. Taken together, the results from this study suggest that pembrolizumab has acceptable safety in patients with both HIV and cancer, although KS herpesvirus-associated B-cell lymphoproliferation is a concern. This study was limited in its small sample size and its nonrandomized nature; more studies with patients with and without HIV are needed to gauge the effectiveness of pembrolizumab on treating cancer in patients with HIV compared to those without HIV.

Click to read the study in JAMA Oncology

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