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Trial Watch: Oncolytic viro-immunotherapy of hematologic and solid tumors

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      Sipuleucel-T immunotherapy for castration-resistant prostate cancer.

      Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P=0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P=0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P=0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; number, NCT00065442.)
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        Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.

        Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-derived oncolytic immunotherapy designed to selectively replicate within tumors and produce granulocyte macrophage colony-stimulating factor (GM-CSF) to enhance systemic antitumor immune responses. T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III trial.
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          Anticancer immunotherapy by CTLA-4 blockade relies on the gut microbiota.

          Antibodies targeting CTLA-4 have been successfully used as cancer immunotherapy. We find that the antitumor effects of CTLA-4 blockade depend on distinct Bacteroides species. In mice and patients, T cell responses specific for B. thetaiotaomicron or B. fragilis were associated with the efficacy of CTLA-4 blockade. Tumors in antibiotic-treated or germ-free mice did not respond to CTLA blockade. This defect was overcome by gavage with B. fragilis, by immunization with B. fragilis polysaccharides, or by adoptive transfer of B. fragilis-specific T cells. Fecal microbial transplantation from humans to mice confirmed that treatment of melanoma patients with antibodies against CTLA-4 favored the outgrowth of B. fragilis with anticancer properties. This study reveals a key role for Bacteroidales in the immunostimulatory effects of CTLA-4 blockade.

            Author and article information

            [1 ] Gustave Roussy Comprehensive Cancer Institute, Villejuif, France
            [2 ] INSERM, Paris, France
            [3 ] Equipe 11 labellisée par la Ligue Nationale contre le Cancer, Centre de Recherche des Cordeliers, Paris, France
            [4 ] Université Paris Descartes/Paris V, Sorbonne Paris Cité, Paris, France
            [5 ] Université Pierre et Marie Curie/Paris VI, Paris, France
            [6 ] McMaster Immunology Research Centre, McMaster University, Hamilton, ON, Canada
            [7 ] Institute for Infectious Disease Research, McMaster University, Hamilton, ON, Canada
            [8 ] Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada
            [9 ] Department of Pathology, Dalhousie University, Halifax, NS, Canada
            [10 ] Department of Microbiology and Immunology, Dalhousie University, NS, Canada
            [11 ] Department of Biology, Dalhousie University, NS, Canada
            [12 ] Centre for Innovative and Collaborative Health Sciences Research, Quality and System Performance, IWK Health Centre, Halifax, NS, Canada
            [13 ] Cancer Therapeutics, Ottawa Hospital Research Institute, Ottawa, ON, Canada
            [14 ] Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, ON, Canada
            [15 ] INSERM, Villejuif, France
            [16 ] Transgene S.A., Illkirch-Graffenstaden, France
            [17 ] Sotio a.c., Prague, Czech Republic
            [18 ] Department of Immunology, 2nd Faculty of Medicine, University Hospital Motol, Charles University, Prague, Czech Republic
            [19 ] Department of Radiation Oncology, Weill Cornell Medical College, New York, NY, USA
            [20 ] Sandra and Edward Meyer Cancer Center, New York, NY, USA
            Informa UK Limited
            September 07 2018
            December 02 2018
            August 27 2018
            December 02 2018
            : 7
            : 12
            : e1503032
            © 2018


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