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
Authors: El Zarif Talal , Nassar Amin H. , Adib Elio , Fitzgerald Bailey G. , Huang Jiaming , Mouhieddine Tarek H. , Rubinstein Paul G. , Nonato Taylor , McKay Rana R. , Li Mingjia , Mittra Arjun , Owen Dwight H. , Baiocchi Robert A. , Lorentsen Michael , Dittus Christopher , Dizman Nazli , Falohun Adewunmi , Abdel-Wahab Noha , Diab Adi , Bankapur Anand , Reed Alexandra , Kim Chul , Arora Aakriti , Shah Neil J. , El-Am Edward , Kozaily Elie , Abdallah Wassim , Al-Hader Ahmad , Abu Ghazal Batool , Saeed Anwaar , Drolen Claire , Lechner Melissa G. , Drakaki Alexandra , Baena Javier , Nebhan Caroline A. , Haykal Tarek , Morse Michael A. , Cortellini Alessio , Pinato David J. , Dalla Pria Alessia , Hall Evan , Bakalov Veli , Bahary Nathan , Rajkumar Aarthi , Mangla Ankit , Shah Vishal , Singh Parminder , Aboubakar Nana Frank , Lopetegui-Lia Nerea , Dima Danai , Dobbs Ryan W. , Funchain Pauline , Saleem Rabia , Woodford Rachel , Long Georgina V. , Menzies Alexander M. , Genova Carlo , Barletta Giulia , Puri Sonam , Florou Vaia , Idossa Dame , Saponara Maristella , Queirolo Paola , Lamberti Giuseppe , Addeo Alfredo , Bersanelli Melissa , Freeman Dory , Xie Wanling , Reid Erin G. , Chiao Elizabeth Y. , Sharon Elad , Johnson Douglas B. , Ramaswami Ramya , Bower Mark , Emu Brinda , Marron Thomas U. , Choueiri Toni K. , Baden Lindsey R. , Lurain Kathryn , Sonpavde Guru P. , Naqash Abdul Rafeh 
Published: May 2023

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.