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437 Safety and efficacy of immune checkpoint inhibitors (ICI) in patients living with HIV (PLWH) and metastatic non-small cell lung cancer (NSCLC): a matched cohort study from the international CATCH-IT consortium
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  1. Talal El Zarif1,
  2. Amin Nassar2,
  3. Elio Adib3,
  4. Bailey Fitzgerald4,
  5. Jiaming Huang1,
  6. Tarek Mouhieddine4,
  7. Taylor Nonato5,
  8. Rana McKay5,
  9. Mingjia Li6,
  10. Arjun Mittra6,
  11. Dwight Owen6,
  12. Michael Lorentsen7,
  13. Christopher Dittus7,
  14. Nazli Dizman2,
  15. Brinda Emu2,
  16. Adewunmi Falohun8,
  17. Noha Abdel-Wahab8,
  18. Anand Bankapur9,
  19. Alexandra Reed9,
  20. Ryan Dobbs9,
  21. Chul Kim10,
  22. Aakriti Arora10,
  23. Neil Shah11,
  24. Edward El-Am12,
  25. Elie Kozaily12,
  26. Wassim Abdallah13,
  27. Ahmad Al-Hader12,
  28. Batool Abu Ghazal14,
  29. Anwaar Saeed14,
  30. Claire Drolen15,
  31. Melissa Lechner15,
  32. Javier Espinar16,
  33. Caroline Nebhan17,
  34. Douglas Johnson17,
  35. Tarek Haykal18,
  36. Michael Morse18,
  37. Alessio Cortellini19,
  38. David Pinato19,
  39. Alessia Dalla Pria19,
  40. Mark Bower19,
  41. Evan Hall20,
  42. Veli Bakalov21,
  43. Nathan Bahary21,
  44. Aarthi Rajkumar22,
  45. Ankit Mangla22,
  46. Vishal Shah23,
  47. Parminder Singh23,
  48. Frank Aboubakar Nana24,
  49. Nerea Lopetegui Lia25,
  50. Danai Dima25,
  51. Pauline Funchain25,
  52. Rabia Saleem26,
  53. Rachel Woodford27,
  54. Georgina Long AO27,
  55. Alexander Menzies27,
  56. Carlo Genova28,
  57. Giulia Barletta28,
  58. Sonam Puri29,
  59. Vaia Florou29,
  60. Dame Idossa30,
  61. Paola Queirolo31,
  62. Giuseppe Lamberti1,
  63. Alfredo Addeo32,
  64. Melissa Bersanelli33,
  65. Dory Freeman1,
  66. Wanling Xie1,
  67. Ramya Ramaswami34,
  68. Thomas Marron35,
  69. Toni Choueiri1,
  70. Kathryn Lurain34,
  71. Lindsey Baden3,
  72. Guru Sonpavde1 and
  73. Abdul Rafeh Naqash36
  1. 1Dana-Farber Cancer Institute, Boston, MA, United States
  2. 2Yale University School of Medicine, New Haven, CT, United States
  3. 3Brigham and Women's Hospital, Boston, MA, United States
  4. 4Tisch Cancer Institute, Mount Sinai, New York, NY, United States
  5. 5University of California San Diego, La Jolla, CA, United States
  6. 6The Ohio State University, Columbus, OH, United States
  7. 7University of North Carolina-Chapel Hill, Chapel Hill, NC, United States
  8. 8MD Anderson Cancer Center, Houston, TX, United States
  9. 9Cook County Hospital, Chicago, IL, United States
  10. 10Georgetown University, Washington, DC, DC, United States
  11. 11Memorial Sloan Kettering Cancer Center, New York, NY, United States
  12. 12Indiana University, Indianapolis, IN, United States
  13. 13Emory University, Atlanta, GA, United States
  14. 14Kansas University Cancer Center, Kansas City, KS, United States
  15. 15University of California Los Angeles, Los Angeles, CA, United States
  16. 16Doce de Octubre University Hospital, Madrid, Spain
  17. 17Vanderbilt University Medical Center, Nashville, TN, United States
  18. 18Duke University Medical Center, Durham, NC, United States
  19. 19Imperial College London, London, UK
  20. 20University of Washington, Seattle, WA, United States
  21. 21Allegheny Health Network, Pittsburgh, PA, United States
  22. 22University Hospitals, Cleveland, OH, United States
  23. 23Mayo Clinic, Tucson, AZ, United States
  24. 24Université Catholique de Louvain (UCL), Brussels, Belgium
  25. 25Cleveland Clinic Foundation, Cleveland, OH, United States
  26. 26Oklahoma University Stephenson Cancer, Oklahoma, OK, United States
  27. 27Melanoma Institute of Australia, Sydney, Australia
  28. 28IRCCS Ospedale Policlinico San Martino, Genova, Italy
  29. 29Huntsman Cancer Institute, Salt Lake City, UT, United States
  30. 30University of California San Francisco, San Francisco, CA, United States
  31. 31IEO European Institute of Oncology Milan, Milan, Italy
  32. 32Geneva University Hospitals, Geneva, Switzerland
  33. 33University Hospital of Parma, Parma, Italy
  34. 34Center for Cancer Research, Bethesda, MD, United States
  35. 35Icahn School of Medicine at Mount Sinai, New York, NY, United States
  36. 36Oklahoma University, Oklahoma City, OK, United States
  • Journal for ImmunoTherapy of Cancer (JITC) preprint. The copyright holder for this preprint are the authors/funders, who have granted JITC permission to display the preprint. All rights reserved. No reuse allowed without permission.

Abstract

Background Due to limited inclusion of PLWH in most ICI clinical trials, there is a paucity of data evaluating their safety and efficacy in this unique population, especially among PLWH and metastatic NSCLC.

Methods In this retrospective, international multi-center study, we identified 64 HIV positive (HIV+) patients and 117 matched HIV negative (HIV-) controls with metastatic NSCLC treated with ICI between January 2015 and October 2021 at 16 institutions in the U.S. and Europe. At each institution, we matched 1 HIV+ patient to 2 or 1 HIV- controls (1:2 or 1:1 ratio) by age, sex, class of ICI, use of concurrent chemotherapy, and number of prior lines of systemic therapy. We estimated overall survival (OS) and progression-free survival (PFS) by the Kaplan-Meier method. When the proportional hazards assumption was violated, we used restricted mean survival time (RMST) to compare survival outcomes. We fitted a linear regression model with RMST as outcome and HIV infection as predictor, adjusting for race, ECOG performance status, histology, smoking status and PD-L1 expression. We compared categorical variables using chi-square tests.

Results In our cohort, median age was 60 years, 77% were males, 61% received ICI as 1st line therapy, 89% received anti-PD-1 based therapy, and 46% received concurrent chemotherapy. Blacks/African Americans were more represented among HIV+ vs. HIV- patients (42% vs 23%, p <0.01). At baseline, HIV+ patients had a median CD4 count = 386 cells/uL (range: 6 – 1,721), 19/31 had undetectable HIV viral load (VL) while 12/31 had a median detectable VL= 60 copies/mL (range: 10 – 223,408). Grade ≥3 immune-related adverse events occurred in 11% HIV+ vs. 9% HIV- patients. Overall response rate was similar between both groups (28% HIV+ vs. 37% HIV-, p=0.25). Comparing HIV+ vs. HIV- pts, the adjusted RMST difference within 42 months was 1.75 months (95% CI: -4.13, 7.63, p=0.56) for OS, and 0.35 months (95% CI: -4.83, 5.53, p=0.90) for PFS (figures 1 and 2). In addition, the 24-month OS rates were 41.7% for HIV+ vs. 42.9% for HIV- patients while the 24-month PFS rates were 18.1% HIV+ vs 18.7% HIV- patients.

Abstract 437 Figure 1

Kaplan-Meier curves for Overall Survival stratified by HIV status

Abstract 437 Figure 2

Kaplan-Meier curves for Progression-Free Survival stratified by HIV status

Conclusions In this matched cohort study, PLWH and metastatic NSCLC had similar toxicity profiles and clinical outcomes to HIV- counterparts receiving ICI supporting their use in PLWH and their inclusion in clinical trials. Larger prospective studies are needed to inform a broader usage of ICI among PLWH presenting with other cancer types, low CD4 counts (i.e., <200 cells/uL) and high VL.

Ethics Approval Our study was exempt from institutional review board (IRB) review at DFCI (Protocol #21-342) and was approved by local IRBs at participating sites per institutional policy, according to the principles of the Declaration of Helsinki.

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