Kite, a Gilead Company, and Pfizer said today they will assess a combination therapy for refractory large B-cell lymphoma that combines Kite’s approved chimeric antigen receptor T-cell (CAR-T) treatment Yescarta™ (axicabtagene ciloleucel) with Pfizer’s Phase I immunotherapy candidate utomilumab (PF-05082566).

The companies said a multi-center Phase I/II study to be sponsored by Kite is expected to launch in 2018. The study’s results will be used to evaluate options for further development of the combination, or similar combinations between Kite’s engineered T cell products and utomilumab, a fully humanized 4-1BB agonist monoclonal antibody.

Yescarta was approved in October as the second CAR-T therpay to win FDA authorization, and the first indicated for adults 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 (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL).

The Yescarta approval came 15 days after Gilead completed its approximately $11.9 billion acquisition of Kite (formerly Kite Pharma).

“Kite is committed to realizing the full potential of Yescarta and other cell therapy technologies across a range of cancers,” David Chang, M.D., Ph.D., Kite worldwide head of research and development and CMO. “We are pleased to collaborate with Pfizer on this study with utomilumab, which adds to the growing number of combination approaches we are exploring with Yescarta for patients living with lymphoma.”

Utomilumab has been shown in preclinical models to enhance T cell mediated immune responses. Pfizer is investigating utomilumab in both hematologic cancers and solid tumors as a single agent and in combination with other anti-cancer therapies.

Pfizer has also cited evidence that suggests that 4-1BB, a costimulatory protein expressed on activated T cells, is upregulated upon exposure to CD19-expressing tumor cells. Pfizer reasons that utomilumab could potentially enhance T cell proliferation and activity by augmenting the CD28 costimulatory domain of Yescarta with exogenous 4-1BB signaling.

In September, Pfizer and The University of Texas MD Anderson Cancer Center agreed to study novel combinations of utomilumab and several of the pharma giant’s other immuno-oncology candidates and other Pfizer treatments for solid and blood cancers.

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