Cancer Immunotherapy Trials Network 12: Pembrolizumab in HIV-Associated Kaposi Sarcoma.

Autor:	Lurain K; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Ramaswami R; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Ekwede I; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Eulo V; University of Alabama at Birmingham, Birmingham, AL., Goyal G; University of Alabama at Birmingham, Birmingham, AL., Menon M; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA., Odeny TA; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Sharon E; Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Bethesda, MD.; Dana-Farber Cancer Institute, Boston, MA., Wagner MJ; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA.; Dana-Farber Cancer Institute, Boston, MA., Wang CJ; University of California San Francisco, San Francisco, CA., Bhardwaj N; Icahn School of Medicine at Mount Sinai Hospital, New York, NY., Friedlander PA; Icahn School of Medicine at Mount Sinai Hospital, New York, NY., Abdul-Hay M; Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY., Cornejo Castro EM; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Labo N; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Marshall VA; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Miley W; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Moore K; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Roshan R; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Whitby D; Viral Oncology Section, AIDS and Cancer Virus Program, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Frederick, MD., Kask AS; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA., Kaiser J; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA., Han E; Cytel (Shanghai) Co Ltd, Shanghai, China., Wright A; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA., Yarchoan R; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD., Fling SP; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA., Uldrick TS; HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.; Fred Hutchinson Cancer Center and University of Washington, Seattle, WA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Oct 02, pp. JCO2400640. Date of Electronic Publication: 2024 Oct 02.
DOI:	10.1200/JCO.24.00640
Abstrakt:	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.
Databáze:	MEDLINE
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