Study Examines Safety of Immune Checkpoint Inhibitor Therapy in Patients With HIV

No new safety or efficacy concerns were found for advanced-stage cancer patients with HIV infection who received immune checkpoint inhibitor therapy, a systematic review published in JAMA Oncology reported. However, since the conclusions rely largely on case reports, prospective studies are needed before the safety of immune checkpoint inhibitors in cancer patients with HIV can be fully known.

“Having this type of analysis focused on cancer patients that are HIV-positive would help in adjusting the strict regulations about accepting HIV-positive individuals on clinical trials,” said Tatiana Garcia-Bates, PhD, research assistant professor of Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, during an interview with Cancer Network. Historically, patients with HIV have been excluded from cancer clinical trials.  

To investigate the safety and efficacy of immune checkpoint inhibitors in cancer patients with HIV, the study researchers performed a literature review and identified 13 articles (11 case reports and 2 retrospective case series) for analysis. They also reviewed the annual meeting proceedings from major oncology society conferences and found 4 meeting abstracts for analysis.

In total, 73 patients with HIV infection and advanced-stage cancer who received an immune checkpoint inhibitor were identified. Most of the patients (90.4%) were men, and the average age was 56.1 years (range, 30.0–77.0 years). The most common cancer types were non–small-cell lung cancer (34.2%), melanoma (21.9%), and Kaposi sarcoma (12.3%).

Most patients (84.9%) received an anti–programmed cell death 1 (anti–PD-1) therapy. The remaining patients received anti–cytotoxic T-lymphocyte antigen 4 (anti–CTLA-4) therapy (8.2%), anti–PD-1/ anti– CTLA-4 combination therapy (5.5%), or sequential ipilimumab and nivolumab (1.4%). Nearly all patients (95%) were receiving antiretroviral therapy (ART) at the start of their immunotherapy treatment.

In all, 7 of 23 patients with non–small-cell lung cancer (30%) who received either pembrolizumab or nivolumab achieved a response; 3 of 11 patients with melanoma (27%) who received a PD-1 inhibitor, ipilimumab, or ipilimumab plus nivolumab achieved a response; and 5 of 8 patients with Kaposi sarcoma (63%) who received nivolumab achieved a response.  

Garcia-Bates described the response rate of Kaposi sarcoma, a rare cancer typically associated with AIDS, as “intriguing.” She said, “This response rate is quite high compared to other cancers.”

Evaluation of the safety data revealed grade 3 or higher immune-related adverse events occurred in 6 of 70 patients (8.6%). Of the patients with known HIV loads before and after treatment, most of them (26 of 28) continued to have their HIV suppressed, as evidenced by undetectable HIV loads both before and after treatment. Two patients, however, had undetectable HIV before treatment that later became detectable after immunotherapy treatment. 

Of the patients with known CD4 cell counts before and after treatment, slightly more than half (14 of 25) had a higher CD4 cell count, and slightly less than half had a lower CD4 cell count after the start of immunotherapy treatment.

Garcia-Bates cautioned against concluding that immune checkpoint inhibitors are safe in cancer patients with HIV. She noted that study conclusions are based on case reports and retrospective data. Only one prospective study by Thomas Uldrick, MD, National Cancer Institute, and colleagues that aims to evaluate pembrolizumab in HIV-positive cancer patients is included, but it was presented as an abstract and has not yet been published. “It’s important to wait for data from this [prospective] study and other prospective studies to actually have a more definitive answer to the safety question,” she said.