Gilead and its shiny new $12 billion biotech buy Kite Pharma have teamed up with Big Pharma Pfizer to work on a Yescarta-utomilumab combination test in certain blood cancers.
Yescarta (axicabtagene ciloleucel), approved by the FDA last year in the first wave of new CAR-T cell therapies, will be teamed up with Pfizer’s experimental humanized 4-1BB agonist utomilumab in patients with refractory large B-cell lymphoma.
The phase 1/2 study, which will be sponsored by Kite, is expected to begin this year, with the data coming out of the early test slated to be used to “evaluate options for further development of this combination, or similar combinations between Kite’s engineered T cell products and utomilumab,” the pair said in a joint statement.
Yescarta was approved by the FDA last year for 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 got its hands on the drug, for which it is also seeking more blood cancer licenses, through its $12 billion buyout of Kite last year. The newly combined company is lining up to battle Novartis, which has its CAR-T Kymriah (tisagenlecleucel) approved in the U.S. for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).
Yesterday, the therapy was also accepted by the FDA under its priority review system for r/r DLBCL patients who are ineligible for, or relapse after, autologous stem cell transplant (ASCT). The EMA also gave it accelerated assessment for children and young adults with r/r B-cell ALL, as well as adult patients with r/r DLBCL who are ineligible for ASCT.
Meanwhile, Pfizer’s mAb utomilumab, also known as PF-05082566, an investigational 4-1BB agonist, has shown activity in preclinical models to enhance T cell mediated immune responses. Pfizer is currently testing the medication in both blood and solid cancers as a single agent and in combination with other cancer drugs. 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,” Pfizer says.
“Kite is committed to realizing the full potential of Yescarta and other cell therapy technologies across a range of cancers,” said David Chang, M.D., Ph.D., worldwide head of R&D and CMO at Kite. “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.”
This also forms yet another cancer combination between biopharma companies, adding to the ever-growing list of companies combining CAR-T, PD-1/PD-L1, cancer vaccines, oncolytic viruses and more to each other in the hope of achieving greater effect or fewer side effects.