Immunotherapy 'Safe and Efficacious' for Advanced-Stage Cancer Treatment for Patients With HIV

Immune checkpoint inhibitor (ICI) therapy appears to be viable in patients with HIV infection and advanced-stage cancer, according to a JAMA Oncology study, although continued research in this patient population will need to confirm these findings.

Patients with HIV infection are at increased risk for cancer, according to the National Cancer Institute (NCI). In addition, HIV infection is also associated with an increased risk of dying from cancer, which is the leading cause of death in this population among the illnesses not classified as being directly associated with advanced HIV infection.

“Patients with HIV infection still have an increased risk of cancer and non—AIDS-related malignant neoplasms, such as lung cancer, anal cancer, Hodgkin lymphoma and oral cavity or pharyngeal cancer, have emerged as one of the leading causes of death in patients with HIV infection,” the researchers said.

The researchers studied 73 patients (90.4 percent male) between the ages of 30 and 77, with an average age of 56.1 years. The patient data was collected from 13 PubMed articles (11 case reports and two case series). There were 40 cases of patients with HIV infection and advanced-stage cancer who were treated with immune checkpoint inhibition. An additional 33 patients were identified in four meeting abstracts.

Using checkpoint inhibitors for the treatment of advanced-stage cancer in patients with HIV infection was associated with no new safety signals.

“No concerning findings were observed in HIV-infected patients with cancer treated with ICI therapy with regard to immune-related toxic effects and changes in viral status or CD4 cell count,” said the researchers.

Immunotherapy was generally well tolerated among the patients, with significant (grade 3 or higher) immune-related adverse events (irAEs) noted in just six out of 70 patients (8.6 percent). irAEs included insulin-dependent diabetes, colitis, myositis and hepatitis, but had no association with adverse changes in HIV load or CD4 cell count. HIV remained suppressed in the majority of patients with undetectable HIV load, and CD4 cell counts increased posttreatment.

Among the 45 patients in whom responses were reported, most patients had received previous systemic treatment. Objective response rates were 30 percent for patients with non—small cell lung cancer (NSCLC) treated with either Keytruda (pembrolizumab) or Opdivo (nivolumab); 27 percent for melanoma treated with a PD-1 inhibitor, Yervoy (ipilimumab) or Yervoy plus Opdivo; and 63 percent for Kaposi sarcoma treated with Opdivo. The researchers determined that the response rates suggest antitumor activity of these immunotherapy agents in patients with HIV infection.

“ICI therapy may be considered as a viable treatment option for HIV-infected patients with advanced cancer,” concluded the researchers. “Prospective trials of ICIs are necessary to elucidate the antiviral efficacy of ICI therapy in patients with HIV infection and cancer.”

There are several ongoing clinical trials of checkpoint inhibitors in patients with HIV infection and advanced-stage cancer, including a phase 2 IFCT study testing disease control rate with Opdivo after prior chemotherapy in stage 3b or metastatic NSCLC.

“The results of these trials will shed further light on the safety and efficacy of ICI therapy in patients with HIV infection,” researchers added.