Safety and Activity of Immune Checkpoint Inhibitors in People Living With HIV and Cancer: A Real-World Report From the Cancer Therapy Using Checkpoint Inhibitors in People Living With HIV-International (CATCH-IT) Consortium

Abstract

Purpose: Compared with people living without HIV (PWOH), people living with HIV (PWH) and cancer have traditionally been excluded from immune checkpoint inhibitor (ICI) trials. Furthermore, there is a paucity of real-world data on the use of ICIs in PWH and cancer.

Methods: This retrospective study included PWH treated with anti-PD-1- or anti-PD-L1-based therapies for advanced cancers. Kaplan-Meier method was used to estimate overall survival (OS) and progression-free survival (PFS). Objective response rates (ORRs) were measured per RECIST 1.1 or other tumor-specific criteria, whenever feasible. Restricted mean survival time (RMST) was used to compare OS and PFS between matched PWH and PWOH with metastatic NSCLC (mNSCLC).

Results: Among 390 PWH, median age was 58 years, 85% (n = 331) were males, 36% (n = 138) were Black; 70% (n = 274) received anti-PD-1/anti-PD-L1 monotherapy. Most common cancers were NSCLC (28%, n = 111), hepatocellular carcinoma ([HCC]; 11%, n = 44), and head and neck squamous cell carcinoma (HNSCC; 10%, n = 39). Seventy percent (152/216) had CD4+ T cell counts ≥200 cells/µL, and 94% (179/190) had HIV viral load <400 copies/mL. Twenty percent (79/390) had any grade immune-related adverse events (irAEs) and 7.7% (30/390) had grade ≥3 irAEs. ORRs were 69% (nonmelanoma skin cancer), 31% (NSCLC), 16% (HCC), and 11% (HNSCC). In the matched mNSCLC cohort (61 PWH v 110 PWOH), 20% (12/61) PWH and 22% (24/110) PWOH had irAEs. Adjusted 42-month RMST difference was -0.06 months (95% CI, -5.49 to 5.37; P = .98) for PFS and 2.23 months (95% CI, -4.02 to 8.48; P = .48) for OS.

Conclusion: Among PWH, ICIs demonstrated differential activity across cancer types with no excess toxicity. Safety and activity of ICIs were similar between matched cohorts of PWH and PWOH with mNSCLC.

FIG 1.

Flowchart of the study design. ^aMatched variables are sex, age group, ICI class, use of chemotherapy, and number of lines of prior systemic therapy. ICI, immune checkpoint inhibitor; NSCLC, non–small-cell lung cancer; PWH, people living with HIV; PWOH, people living without HIV.

FIG 2.

Safety profiles and activity of ICIs among PWH. (A) irAEs by type; cumulative incidence of irAEs among (B) CD4+ T-cell counts and (C) CD4:CD8 ratio subgroups; and (D) ORR across top 10 cancer types. HCC, hepatocellular carcinoma; HL, Hodgkin lymphoma; HNSCC, head and neck squamous cell carcinoma; ICI, immune checkpoint inhibitor; irAEs, immune-related adverse events; KS, Kaposi sarcoma; NHL, non-Hodgkin lymphoma; NSCLC, non–small-cell lung cancer; ORR, objective response rate; PWH, people living with HIV; SCLC, small-cell lung cancer.

FIG 3.

Kaplan-Meier analysis of (A) OS and (B) PFS between PWH and PWOH with mNSCLC. The gray area corresponds to the difference in the areas under the survival curves or the RMST up to 42 months after ICI initiation (milestone time) where the number of PWH or PWOH is ≥5. ICI, immune checkpoint inhibitor; mNSCLC, metastatic non–small-cell lung cancer; OS, overall survival; PFS, progression-free survival; PWH, people living with HIV; PWOH, people living without HIV; RMST, restricted mean survival time.