Journal article
Preliminary results from an early phase trial of in situ immunization of lymphoma with a virus likeparticle containing a TLR9 agonist combined with anti-PD1 therapy (NCT03983668)
Journal of clinical oncology, Vol.40(16_suppl), pp.2639-2639
06/01/2022
DOI: 10.1200/JCO.2022.40.16_suppl.2639
Abstract
2639 Background: In situ immunization involves intratumoral (IT) injection of immunostimulatory agents to modify the tumor microenvironment with the goal of inducing an anti-tumor T cell response. Here, we report preliminary results of a clinical trial exploring in situ immunization with a virus like particle (VLP) combined with systemic pembrolizumab (Pembro) in lymphoma. The VLP, known as CMP-001 or vidutolimod (Vidu), is composed of the bacteriophage Qb capsid encapsulating the TLR9 agonist G10. Preclinical studies demonstrated generation of antibodies against the Qb capsid (anti-Qb) is necessary for Vidu to induce an anti-tumor response. In other cancers, early phase clinical trials of in situ immunization with Vidu, with and without systemic anti-PD1 therapy, have revealed early promising results. Methods: This trial included patients with relapsed lymphoma that have failed at least 1 line of therapy. The first dose of Vidu is given subcutaneously to stimulate anti-Qb that opsonizes the VLP. This is followed by IT Vidu administered weekly for seven doses, then at 3-week intervals. Pembro (200 mg fixed dose) is given intravenously every 3 weeks. Subjects continue treatment if they do not experience unacceptable toxicities and in the investigator’s opinion continued treatment is in the subject’s best interest. Fine needle aspirates for flow cytometric analysis are obtained prior to therapy and 4-6 weeks following initiation of therapy. Results: Six patients have enrolled to date (1 CR, 2 PR, 1 SD, 2 PD). The first 3 patients received 5mg Vidu per dose and the second cohort 7.5 mg per dose. Common side effects included chills, rigors, mild headache, and fatigue. These typically resolved within 4 hours after receiving the injection. Conclusions: In situ immunization with Vidu plus systemic anti-PD1 is a promising therapy in lymphoma. The ability to generate anti-Qb that opsonizes the VLP appears to be necessary for Vidu to induce an immune and therapeutic response. Accrual and correlative studies are continuing with the modification that generation of functional-Qb after the first dose of Vidu is required before patients receive IT therapy. Clinical trial information: NCT03983668. [Table: see text]
Details
- Title: Subtitle
- Preliminary results from an early phase trial of in situ immunization of lymphoma with a virus likeparticle containing a TLR9 agonist combined with anti-PD1 therapy (NCT03983668)
- Creators
- Umar Farooq - University of IowaSabarish Ram Ayyappan - University of IowaChaobo Yin - University of IowaCaitlin Lemke-Miltner - University of IowaBrian J. Smith - University of IowaBrian K. Link - University of IowaGeorge J. Weiner - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.40(16_suppl), pp.2639-2639
- DOI
- 10.1200/JCO.2022.40.16_suppl.2639
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- DOI: 10.13039/100000002, name: U.S. National Institutes of Health; name: Pharmaceutical/Biotech Company.
- Language
- English
- Date published
- 06/01/2022
- Academic Unit
- Holden Comprehensive Cancer Center; Internal Medicine; Biostatistics; Hematology, Oncology, and Blood & Marrow Transplantation; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984274716402771
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