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 by El Zarif et al at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting (Abstract 437).
Findings from the first matched cohort to compare clinical outcomes between people living with and without HIV who were also diagnosed with metastatic NSCLC showed similar toxicity profiles and no new safety signals when patients received immune checkpoint inhibitors.
Overall response rate, progression-free survival, and overall survival were also comparable between people living with HIV and those without HIV, authors of the study reported.
“If a physician designs a treatment plan that includes an immune checkpoint inhibitor, finding out that the patient has HIV should not discourage the clinical decision to administer immunotherapy when indicated,” said lead author of the study Talal El Zarif, MD, a research fellow in oncology at Dana-Farber Cancer Institute.
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 Dr. El Zarif.
Study Methods
To capture real-world data of patients with cancer who are living with HIV, a study led by Dr. El Zarif and colleagues established the CATCH-IT consortium at Dana-Farber Cancer Institute and expanded to other cancer centers in the United States, Europe, and Australia. NSCLC was found to be the most common cancer in the cohort of 417 patients.
“People living with HIV are living longer now, which means that they are susceptible to the cancer types that are present in the general population, and not only HIV-related malignancies like Kaposi’s sarcoma or non-Hodgkin’s lymphoma,” said senior author of the study Abdul Rafeh Naqash, MD, Assistant Professor of Medicine at Stephenson Cancer Center, University of Oklahoma
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 therapy were included in the analysis and were matched with patients living without HIV according to five variables: age, sex, class of immune checkpoint inhibitor, receipt of chemotherapy, and the number of prior lines of therapy.
Safety Profiles and Survival Data Similar Between Cohorts
As Dr. El Zarif and colleagues reported, safety profiles were found to be similar between both cohorts. For example, only 19% of people living with HIV experienced immune-related adverse events vs 24% of people living without HIV. In addition, only 11% of the patients experienced grade 3 or 4 adverse events in both cohorts.
With respect to efficacy, the overall response to immune checkpoint inhibition was 28% for people living with HIV vs 37% for those without HIV, but this difference was not shown to be statistically significant. Two years after starting immune checkpoint inhibitors, the data showed that 41.7% of people living with HIV were alive compared to 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 progression-free at 2 years vs 18.7% for those without HIV.
“These are similar numbers keeping in mind that since this was a retrospective study, we could not match for all the confounders among the two cohorts,” said study coauthor Amin Nassar, MD, a clinical fellow in medical oncology at Yale University.
Future Directions
In the future, Dr. El Zarif and colleagues are looking to leverage the consortium to conduct tumor-based tissue analyses that could help researchers understand differences in the tumor microenvironment of NSCLC in people living with HIV vs those without HIV.
“We’d like to see if HIV affects T cells that are critical for the effectiveness of immunotherapy … I think we could better understand this relationship with a larger cohort and tumor-based tissue studies,” said study coauthor Elio Adib, MD, internal medicine resident at the Brigham and Women’s Hospital.
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 other [cancer types]. 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 serving as Genitourinary Oncology Director at AdventHealth Orlando.
Disclosure: For full disclosures of the study authors, visit jitc.bmj.com.
