Cancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma
Abstract
PURPOSE Cancer Immunotherapy Trials Network 12 demonstrated safety of pembrolizumab in treating advanced cancer in people with HIV. Here, we report results of the Kaposi sarcoma (KS) cohort. METHODS In this multicenter phase I trial, we enrolled participants with HIV-associated KS on antiretroviral therapy with CD4 + ≥50 cells/μL and HIV plasma RNA <200 copies/mL. Pembrolizumab 200 mg intravenously was administered once every 3 weeks for up to 35 cycles. The primary end point was safety, and the secondary end point was KS response by modified AIDS Clinical Trials Group Criteria. RESULTS Thirty-two cisgender men enrolled with baseline median CD4 + T-cell count of 274 cells/µL. All but nine participants had received previous systemic KS therapy. Participants received a median of 11 cycles of pembrolizumab (range, 1-35). Sixty-six percent had grade ≥1 treatment-emergent adverse events, including one death from polyclonal KS herpesvirus–related B-cell lymphoproliferation. Thirty-one percent had ≥one immune-mediated AEs (imAEs) with 25% requiring systemic steroids. In 29 participants with evaluable KS, the overall response rate (ORR) was 62.1% (95% CI, 42.3 to 79.3) and did not differ by CD4 + T-cell count. ORR in the eight participants with evaluable disease without previous KS therapy was 87.5% (95% CI, 47.3 to 99.7). Median duration of response (DOR) was not reached, and the Kaplan-Meier estimate of DOR of ≥12 months was 92.3% (95% CI, 56.6 to 98.8). Median progression-free survival was 28.2 months (95% CI, 4.2 to noncalculable). CONCLUSION Pembrolizumab yielded a high rate of durable responses in HIV-associated KS. imAEs were successfully managed with standard guidelines.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (27)
Kathryn Lurain
9HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Ramya Ramaswami
1National Cancer Institute, Bethesda, United States
Irene Ekwede
1National Cancer Institute, Bethesda, United States
Vanessa Eulo
University of Alabama at Birmingham, Birmingham, AL
Gaurav Goyal
1Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, AL
Manoj Menon
Fred Hutchinson Cancer Research Center, Seattle, WA
Thomas A. Odeny
Washington University in St. Louis, St. Louis, MO
Elad Sharon
Michael J. Wagner
Chia-Ching (Jackie) Wang
University of California San Francisco, San Francisco, CA
Nina Bhardwaj
Marc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Philip A. Friedlander
Icahn School of Medicine at Mount Sinai Hospital, New York, NY
Maher Abdul-Hay
1Perlmutter Cancer Center, New York University Langone Health, New York City, United States
Elena M. Cornejo Castro
National Institutes of Health, Frederick, MD
Nazzarena Labo
NCI/FNLCR, Frederick, MD
Vickie Ann Marshall
Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD
Wendell Miley
Leidos Biomedical Research, Inc., Frederick, MD
Kyle Moore
Romin Roshan
2Leidos-Biomedical, Frederick National Laboratory for Cancer Research, Viral Oncology Section, AIDS and Cancer Virus Program, Frederick, United States
Denise Whitby
2Leidos-Biomedical, Frederick National Laboratory for Cancer Research, Viral Oncology Section, AIDS and Cancer Virus Program, Frederick, United States
Angela Shaulov Kask
Fred Hutchinson Cancer Center and University of Washington, Seattle, WA
Judith Kaiser
Fred Hutchinson Cancer Center and University of Washington, Seattle, WA
Emma Han
Cytel (Shanghai) Co Ltd, Shanghai, China
Anna Wright
Fred Hutchinson Cancer Center and University of Washington, Seattle, WA
Robert Yarchoan
National Cancer Institute
Steven P. Fling
Fred Hutchinson Cancer Center and University of Washington, Seattle, WA
Thomas S. Uldrick
Regeneron Pharmaceuticals, Inc., Tarrytown, NY