Real-World Data on ICI in Patients With HIV and Cancer

Patients with cancer who also have HIV are often excluded from clinical trials, so there is a paucity of data on how immune checkpoint inhibitors (ICIs) work in this particular patient population.

A retrospective database analysis shows that ICIs have activity across a range of cancers in people with HIV, and are not associated with excess toxicity this group.

The findings “add to the growing body of evidence supporting the use of ICIs among people with HIV to enhance their inclusion in ICI clinical studies,” wrote the investigators, led by Talal El Zarif, MD, of Dana-Farber Cancer Institute, Boston.

The study was published online May 16 in the Journal of Clinical Oncology.

It was based on an analysis of data from the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International Consortium (CATCH-IT).

The team identified 390 patients with HIV and cancer who had received at least one dose of an immune checkpoint inhibitor, and 70% received anti-PD-1/anti-PD-L1 monotherapy.

These patients had a median age of 58 years, 85% were men, and 36% were Black.

The most common cancer types among the patients were non-small cell lung cancer (NSCLC) in 28% of cases, hepatocellular carcinoma (HCC) in 11% of cases, and head and neck squamous cell carcinoma (HNSCC) in 10% of cases.

Overall response rates were 69% for nonmelanoma skin cancer, 31% for NSCLC, 16% for HCC, and 11% for HNSCC, noted the investigators.

Immune-related adverse events (irAEs) occurred in 79 (20%) of 390 patients included in the study, and 30 of 390 patients had grade 3 or greater irAEs.

Of note, 30% of people with HIV who were treated with ICIs had baseline CD4+ T-cell counts less than 200 cells/µL — and the incidence of irAEs was similar in those patients and in patients with baseline CD4+ T-cell counts greater than 200 cells/µL.

Comparison With Matched Controls

An additional analysis compared the effects of ICIs in a cohort of 61 patients with HIV and metastatic NSCLC with a cohort of 110 matched controls who did not have HIV.

The activity and safety if the ICIs were similar in the two groups, say the investigators.

For these patients with NSCLC, there was an adjusted 42-month restricted mean survival time (RMST) difference between patients with HIV and patients without HIV of 2.23 months for overall survival (OS) and -0.06 months for progression-free survival (PFS).

In addition, the 24-month OS rates for people with HIV were 42.3% vs 41.5% for people without HIV, and the 24-month PFS rates were 17.8% vs 18.4%, respectively. The overall response rate (ORR) was similar between both groups (28% for people with HIV vs 36% for people without HIV, P = .31).

Immune-related AEs occurred in 20% of people with HIV and 22% of people without HIV. Additionally, grade 3 or greater irAEs occurred in 12% vs 9.1%, respectively, and systemic steroids were required for 9.8% and 15%, respectively.

Future studies comparing large, matched cohorts of people with HIV and other cancer types are warranted for comparisons with the general population, the investigators suggested.

The CATCH-IT registry “offers a unique opportunity for additional real-world subanalyses of clinical outcomes of people with HIV receiving ICIs that could guide oncologists treating this unique population as we await results from ongoing ICI clinical trials,” they added.

El Zarif reports no relevant financial relationships. Many co-authors have links to pharmaceutical companies, as listed in the original article.

J Clin Oncol. Published online May 16, 2023. Abstract

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at  [email protected]  or on Twitter:  @SW_MedReporter

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