Pfizer, Kite Pharma in Cancer Clinical Trial Pact
Pfizer has formed a clinical trial collaboration with Kite Pharma, Gilead Sciences’ cell-therapy subsidiary, to evaluate the investigational combination of Gilead’s Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor T cell (CAR T) therapy, and Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients with refractory large B-cell lymphoma.
A multi-center Phase I/II study sponsored by Kite is expected to begin in 2018. The results of this study will be used to evaluate options for further development of this combination or similar combinations between Kite’s engineered T cell products and utomilumab.
Yescarta is the first CAR-T therapy to be indicated for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Yescarta was approved by the US Food and Drug Administration in October 2017.
Utomilumab is an investigational 4-1BB agonist that is designed to enhance T cell-mediated immune responses. Pfizer is currently investigating utomilumab in both hematologic cancers and solid tumors as a single agent and in combination with other anti-cancer therapies. Gilead says evidence also suggests that 4-1BB, a costimulatory protein expressed on activated T cells, is upregulated upon exposure to CD19-expressing tumor cells. Utomilumab could potentially enhance T cell proliferation and activity by augmenting the CD28 costimulatory domain of Yescarta with exogenous 4-1BB signaling, according to Gilead Sciences.
Source: Gilead Sciences