Companies will work to develop a CAR-T mAb treatment for blood cancer.
Pfizer announced that it will be working with Gilead and its recently acquired Kite Pharma business to develop a new treatment combining Gilead’s approved cell therapy yescarta (axicabtagene ciloleucel) with Pfizer’s monoclonal antibody candidate utomilumab, a humanized 4-1BB agonist (4-1BB is a costimulatory protein expressed on activated T cells). The treatment is intended for patients with refractory large B-cell lymphoma. The companies will be conducting a phase 1/2 study sponsored by Kite starting in 2018. The results of the study will then be used to determine further development options for the drug combination.
Yescarta is approved for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Gilead is seeking additional approvals for other blood cancers, and recently Yescarta was accepted by FDA for priority review as a treatment for r/r DLBCL patients who are ineligible for, or relapse after, autologous stem cell transplant (ASCT). The drug is also undergoing accelerated review by EMA for use in children and young adults with r/r B-cell ALL, as well as adult patients with r/r DLBCL who are ineligible for ASCT.
Pfizer has demonstrated that utomilumab (PF-05082566) enhances the activity of T cell mediated immune responses. The company is also investigating its efficacy as a single agent and in combination with other oncology drugs in blood and solid cancers. “Utomilumab could potentially enhance T cell proliferation and activity by augmenting the CD28 costimulatory domain of Yescarta with exogenous 4-1BB signaling,” Pfizer says.