Immune checkpoint inhibitors are safe and effective for people living with HIV who have metastatic non–small cell lung cancer (NSCLC), according to data presented at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting.¹ Findings from the first matched cohort to compare clinical outcomes between people living with and without HIV receiving immune checkpoint inhibitors showed similar toxicity profiles and no new safety signals among patients with metastatic NSCLC. Overall response rate, progression-free survival, and overall survival were also comparable, study authors reported.

“If a physician designs a treatment plan that includes an immune checkpoint inhibitor, finding out whether the patient has HIV should not discourage the clinical decision to administer immunotherapy when indicated,” said co–lead author Talal El Zarif, MD, a research fellow in oncology at Dana-Farber Cancer Institute, Boston.

Talal El Zarif, MD

Amin H. Nassar, MD

Although recent efforts have been made to include people living with HIV in immune checkpoint inhibitor clinical trials, according to Dr. El Zarif and colleagues, physicians treating patients with HIV currently rely on data from clinical trials that were conducted years ago—and excluded patients with HIV. “Up to 74% of clinical trials involving immune checkpoint inhibitors excluded patients with HIV between 2019 and 2020,” said co–lead author Amin H. Nassar, MD, a clinical fellow in medical oncology at Yale University, New Haven.

Study Methods and Key Findings

To capture real-world data of patients with cancer who are living with HIV, a study led by Drs. El Zarif, Nassar, and Adib established the CATCH-IT consortium at Dana-Farber Cancer Institute and expanded to other cancer centers in the United States, Europe, and Australia.

“People living with HIV are living longer now, which means they are susceptible to the cancer types present in the general population and not only HIV-related malignancies such as -Kaposi’s sarcoma or non-Hodgkin lymphoma,” said senior author Abdul Rafeh Naqash, MD, Assistant Professor of Medicine at Stephenson Cancer Center, University of Oklahoma.

Abdul Rafeh Naqash, MD

For this matched cohort study, the researchers chose the most represented cancer type, metastatic NSCLC, as a proof of concept to examine the outcomes of people living with HIV vs people living without HIV. Patients with biopsy-proven metastatic NSCLC who had received at least one cycle of immune checkpoint inhibitor were included in the analysis and were matched with patients living without HIV based on five variables: age, sex, class of immune checkpoint inhibitor, receipt of chemotherapy, and number of prior lines of therapy.

As Dr. El Zarif and colleagues reported, safety profiles were found to be similar between both cohorts. For example, 19% of people living with HIV experienced immune-related adverse events vs 24% of people living without HIV. In addition, 11% of the patients experienced grade 3 or 4 adverse events in both cohorts.

With respect to efficacy, overall response to immune checkpoint inhibition was 28% for people living with HIV vs 37% for those without HIV, but this difference was not statistically significant. About 2 years after starting immune checkpoint inhibitors, the data showed that 41.7% of people living with HIV were alive vs 42.9% of people living without HIV. Progression-free survival was also similar between the two groups, with 18.1% of patients in the HIV cohort remaining free of disease progression at 2 years vs 18.7% of those without HIV.

Future Directions

In the future, Dr. El Zarif and colleagues are looking to leverage the consortium to conduct tumor-based tissue analyses. They believe such analyses may help researchers understand differences in the tumor microenvironment of NSCLC in people living with vs without HIV.

“We’d like to see if HIV affects T cells, which are critical for the effectiveness of immunotherapy,” added co–lead author Elio Adib, MD, internal medicine resident at Brigham and Women’s Hospital, Boston. “I think we could better understand this relationship with a larger cohort and tumor-based tissue studies.”

Elio Adib, MD

Guru P. Sonpavde, MD

Dr. El Zarif and colleagues would also like to update the consortium to include more patients with other cancer types. “We’d like to replicate this matched-comparison approach for bladder cancer, melanoma, lymphoma, and others. These data could help to inform guidance for clinical practice,” said senior author Guru P. Sonpavde, MD, who supervised this effort during his time at Dana-
Farber Cancer Institute before joining AdventHealth Orlando. 

DISCLOSURE: Drs. El Zarif, Nassar, Adib, Naqash, and Sonpavde have reported no conflicts of interest related to this study.

REFERENCE

1. El Zarif T, Nassar A, Adib E, et al: Safety and efficacy of immune checkpoint inhibitors in patients living with HIV and metastatic non-small cell lung cancer. 2022 SITC Annual Meeting. Abstract 437. Presented November 9, 2022.