Immune Checkpoint Inhibitors Safe to Use for NSCLC in Patients With HIV

Patients with both HIV and non–small cell lung cancer (NSCLC) can safely use immune checkpoint inhibitors (ICIs) to treat their cancer, with patient management essential to treating the patient effectively, according to a new review.¹

NSCLC is the most common form of lung cancer, which is one of the most commonly diagnosed cancers and one of the leading causes of cancer death. ICIs are used as first-line treatment for NSCLC and work by boosting the function of CD4 T helper cells. Antiretroviral therapy (ART) used to treat HIV works by restoring CD4 T cell counts. Those with HIV have a higher risk of developing lung cancer.² However, those with HIV are often excluded from clinical trials to test the efficacy of ICIs. This review aimed to assemble past studies to assess the safety of using ICIs in those with HIV and NSCLC.¹

Studies published between January 2015 and September 2025 and indexed in PubMed were eligible for the review. Case reports were excluded from the review, whereas retrospective studies, registry studies, and clinical prospective studies were included. There were 5 studies that were ultimately included in the review.

The first study was the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International Consortium, which retrospectively included 111 people living with both HIV and NSCLC. A total of 61 patients living with metastatic NSCLC were matched with a control group of people living without HIV. All patients had at least 1 dose of an ICI. There were no significant differences in progression-free survival (PFS), overall response rate, or overall survival (OS) between the 2 groups. Immune-related adverse events were found in 22% of the people living with HIV compared with 20% in the control group.

There were 16 patients living with HIV and advanced NSCLC in a study assessing the efficacy of nivolumab. All patients with HIV were treated with ART and were virally suppressed, and all patients received at least 1 cycle of chemotherapy prior to their immunotherapy. Disease control rate was 62.5% after 8 weeks, with 5 patients showing progressive disease. The median PFS was 3.4 months, and the median OS was 10.9 months. Only mild to moderate treatment-related adverse effects were reported.

There were 21 patients with both HIV and NSCLC in a retrospective sub-analysis of the prospective CANCERVIH registry from France. ICI was received as a second-line treatment for 55% of these patients, with nivolumab monotherapy being the most popular. All included participants were virally suppressed and taking either pembrolizumab or nivolumab. Median survival was 10.7 months, and disease control rate was 42.9%.

A French prospective observational cohort study, OncoVIHAC ANRS CO24, included 65 patients with lung cancer and HIV, with NSCLC not specified. Patients were included despite viral suppression status. The estimated 18-month OS was 36.4%, and PFS was 25.5%. There was an immune-related adverse event of grade 3 or higher in 15.4% of the patients. Of those who were virally suppressed at the start of the study, most patients remained virally suppressed by the end.

The PACIFIC trial evaluated the PFS and OS of people without HIV with stage III NSCLC when using durvalumab. Only 1 man with HIV and stage IIIB lung adenocarcinoma was given durvalumab as a response to this trial, which resulted in tumor shrinkage when taken concurrently with chemoradiotherapy, though the patient did discontinue this treatment due to disease progression just 4 months later.

There were some limitations to this study. Most of the data come from retrospective and non-randomized trials. The sample size was small in all studies.

The researchers concluded that ICIs were safe and effective when given to people living with both HIV and NSCLC when looking at past studies, “However, the number of patients included in current studies is limited, and data on dual checkpoint blockade are lacking. Close interdisciplinary collaboration between oncology and HIV care providers is essential—particularly regarding ART management, potential drug interactions, and regular monitoring of immune status and HIV viral load.”

References

1. Mispelbaum R, Hattenhauer T, Hoffmann C, et al. Effective and safe use of immune checkpoint inhibitors for non–small cell lung cancer in people living with HIV. HIV Med. Published online November 5, 2025. doi:10.1111/hiv.70136

2. Sigel K, Makinson A, Thaler J. Lung cancer in persons with HIV. Curr Opin HIV AIDS. 2017;12(1)31-38. doi:10.1097/COH.0000000000000326