Immune Checkpoint Inhibitors Safe, Effective in Cancer Patients With HIV

Immune checkpoint inhibitors showed activity among people with HIV and various cancer types, without any excess or unexpected toxicities, according to a retrospective real-world study.

In a cohort of 390 patients with HIV and cancer, 20% had immune-related adverse events (AEs) of any grade and 7.7% had grade ≥3 immune-related AEs, reported Abdul Rafeh Naqash, MD, of the Stephenson Cancer Center at the University of Oklahoma in Oklahoma City, and colleagues in the Journal of Clinical Oncology.

In addition, the activity of checkpoint inhibitors was similar between patients with HIV and historical and matched controls without HIV.

Specifically, in matched patients with metastatic non-small cell lung cancer (NSCLC) — the most represented cancer type — the adjusted 42-month restricted mean survival time difference between the HIV group (n=61) and no-HIV group (n=110) was -0.06 months (95% CI -5.49 to 5.37, P=0.98) for progression-free survival (PFS) and 2.23 months (95% CI -4.02 to 8.48, P=0.48) for overall survival (OS).

The 24-month OS rates were 42.3% for those with HIV versus 41.5% for those without HIV, while the 24-month PFS rates were 17.8% and 18.4%, respectively. Objective response rates (ORRs) were also similar between the groups (28% vs 36%, P=0.31).

In these NSCLC patients, 20% with HIV had any grade immune-related AEs versus 22% without HIV, while grade ≥3 immune-related AEs occurred in 12% and 9.1%, respectively.

“This study should give some level of confidence to clinicians who are treating patients living with HIV and cancer,” said Naqash in a press release. “They can use this data to guide discussions with their patients when considering immune checkpoint inhibitors [ICIs]. This will serve as a landmark paper in the field, given that little is known about immunotherapy among people with HIV and cancer.”

According to the authors, since patients with HIV may have dysfunctional immune systems, their participation in clinical trials involving checkpoint inhibitors has been restricted due to safety and efficacy concerns. While some recent clinical trials and retrospective studies have suggested the immunotherapies are safe and active in this population, observations have been limited due to small sample sizes.

“Given the potential benefit of ICIs in PWH [people living with HIV] and cancer, larger real-world cohorts are needed to address the existing knowledge gaps, guide clinical decision making, and increase therapeutic opportunities for PWH,” they wrote.

For this study, Naqash and colleagues used data from 33 participating institutions across the U.S., Europe, and Australia in the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) consortium. Of the 390 patients with HIV and cancer, median age was 58 years, 85% were men, 36% were Black, and 14% were Hispanic. Seventy percent had CD4+ T-cell counts ≥200 cells/µL, and 94% had HIV viral load <400 copies/mL.

The most common cancer types were NSCLC (28%), hepatocellular carcinoma (11%), and head and neck squamous cell carcinoma (10%).

All patients with HIV received ≥1 dose of a checkpoint inhibitor, with 70% receiving anti-PD-1/anti-PD-L1 monotherapy.

In 68 patients who received a checkpoint inhibitor with chemotherapy, 19% developed any grade immune-related AEs and 5.9% developed grade ≥3 immune-related AEs, while the 25 who were treated with a checkpoint inhibitor and a targeted agent had rates of 8% and 4%, respectively, and the 23 patients treated with dual checkpoint inhibitor therapy (anti-PD-1 + anti-CTLA-4) had rates of 39% and 13%, respectively.

“Notably, our sample size allowed for examining the rate of immune-related AEs in PWH with CD4+ T-cell counts <200 cells/μL, a subset that is also poorly represented in prior ICI-based trials, yet constituted 30% of our cohort,” Naqash’s group wrote.

The 24-month rate of immune-related AEs in patients with HIV and CD4+ T-cell counts <200 cells/µL was comparable to those with counts ≥200 cells/μL. There was also no significant difference in OS (P=0.88) or PFS (P=0.72) between patients with HIV and NSCLC presenting with baseline CD4+ T-cell counts ≥200 versus <200 cells/µL.

“These data further endorse the need to abrogate arbitrary CD4 cutoffs when using ICIs in the appropriate setting for the treatment of PWH and subsequently reduce barriers to ICI access on the basis of their favorable benefit-to-risk profiles,” Naqash and colleagues noted.