A single-center, prospective, randomized controlled trial of tislelizumab combined with platinum-containing chemotherapy as first-line treatment for HIV-positive patients with advanced non-small cell lung cancer.

e20590 Background: There are few prospective clinical studies of programmed death-1 (PD-1) inhibitors combined with chemotherapy in the treatment of human immunodeficiency virus (HIV)-infected patients with advanced non-small cell lung cancer (NSCLC) since this population has largely been excluded from immunotherapy clinical trials. Methods: The single-center, prospective, randomized controlled trial enrolled stage IIIC-IV NSCLC patients and divided them into HIV-positive and HIV-negative groups based on whether they had HIV infection. All patients received tislelizumab combined with platinum-containing chemotherapy (paclitaxel or nab-paclitaxel or pemetrexed combined with cisplatin or carboplatin) for 4-6 cycles, followed by maintenance therapy with tislelizumab until disease progression or intolerable toxicities. Results: Between January 2023 and December 2024, 17 and 37 patients were enrolled in HIV-positive group and HIV-negative group, respectively. Baseline characteristics were balanced between the two groups (male, 82.4% with HIV-positive group vs 89.4% with HIV-negative group; median age, 61 vs 59 yrs; squamous carcinoma, 76.5% vs 72.3%). The median follow-up was 7.3 months (range,2.5-24m)in HIV-positive group and 13.4 months(range,1.8-24m) in HIV-negative group. Objective response rates (ORR) in HIV-positive group was 76.5% vs 78.3% in HIV-negative group(p=0.746); 6-month duration of response (DOR) rate was 70.6% vs 78.3%(HR 1.110,95% CI 0.782-1.576,p=0.078); 6-month progression free survival (PFS) rate was 82.4% vs 94.6%(HR 1.149,95% CI 0.910-1.450,p=0.876). No new safety signals were observed, and grade 3 or higher immune-related adverse reactions were 5.9% vs 5.4% in HIV-positive group and HIV-negative group, respectively. One patient in HIV-positive group had an opportunistic infection-induced death during the course of treatment. Conclusions: The efficacy and safety of tislelizumab combined with chemotherapy for HIV-positive patients with advanced NSCLC is comparable to that of non-HIV advanced NSCLC patients. However, HIV-positive patients are more susceptible to opportunistic infections and require closer management throughout the course of treatment. The study is ongoing and requires further follow-up.