AI Summary
The study assessed the safety and efficacy of nivolumab in people living with HIV (PLWH) with advanced cancer on antiretroviral therapy. Participants received nivolumab every 2 weeks, with no dose-limiting toxicities observed. Some patients had immune-related adverse events, and there were objective partial responses in 25% of participants, with a longer duration of response in those with Kaposi sarcoma (KS). Plasma HIV remained suppressed, CD4 counts were stable, and there was no adverse impact on immune function. The findings suggest that nivolumab is safe and effective for PLWH with cancer, particularly in cases of KS.
Abstract
Background
Although immunotherapy has emerged as a therapeutic strategy for many cancers, there are limited studies establishing the safety and efficacy in people living with HIV (PLWH) and cancer.
Methods
PLWH and solid tumors or Kaposi sarcoma (KS) receiving antiretroviral therapy and a suppressed HIV viral load received nivolumab at 3 mg/kg every 2 weeks, in two dose deescalation cohorts stratified by CD4 count (stratum 1: CD4 count > 200/µL and stratum 2: CD4 count 100–199/µL). An expansion cohort of 24 participants with a CD4 count > 200/µL was then enrolled.
Results
A total of 36 PLWH received nivolumab, including 15 with KS and 21 with a variety of other solid tumors. None of the first 12 participants had dose-limiting toxicity in both CD4 strata, and five patients (14%) overall had grade 3 or higher immune related adverse events. Objective partial response occurred in nine PLWH and cancer (25%), including in six of 15 with KS (40%; 95% CI, 16.3–64.7). The median duration of response was 9.0 months overall and 12.5 months in KS. Responses were observed regardless of PDL1 expression. There were no significant changes in CD4 count or HIV viral load.
Conclusions
Nivolumab has a safety profile in PLWH similar to HIV-negative subjects with cancer, and also efficacy in KS. Plasma HIV remained suppressed and CD4 counts remained stable during treatment and antiretroviral therapy, indicating no adverse impact on immune function.
Trial Registration
ClinicalTrials.gov Identifier: NCT02408861.