Phase 1/2 Trial to Test Yescarta-Utomilumab Combo in Refractory Large B-cell Lymphoma

Phase 1/2 Trial to Test Yescarta-Utomilumab Combo in Refractory Large B-cell Lymphoma

A new multicenter Phase 1/2 trial will evaluate an immunotherapy combination of Yescarta (axicabtagene ciloleucel) and utomilumab for the treatment of patients with refractory large B-cell lymphoma.

The trial, part of a clinical collaboration between Kite Pharma and Pfizer, is expected to start in 2018.

“Kite is committed to realizing the full potential of Yescarta and other cell therapy technologies across a range of cancers,” David Chang, MD, PhD, worldwide head of research and development and chief medical officer at Kite, said in a press release. “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.”

Yescarta, the second chimeric antigen receptor (CAR) T-cell therapy to be approved anywhere in the world, and the first for lymphoma patients, uses a patient’s own re-engineered immune cells to fight cancer.

It is indicated for patients with relapsed or refractory large B-cell lymphoma who received at least two prior therapies. This includes diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

In the Phase 1/2 ZUMA-1 trial (NCT02348216), 40 percent of patients with large B-cell lymphoma whose disease had progressed following at least two prior lines of therapy saw a complete eradication of their tumors after receiving Yescarta, after a median follow-up of 15.4 months. An additional 2 percent also are responding to a single infusion of the therapy.

Findings from the ZUMA-1 trial were presented last month at the 59th American Society of Hematology Annual Meeting.

Utomilumab, formerly known as PF-05082566, is an agonist of 4-1BB, a member of the tumor necrosis factor family. The medicine is a humanized antibody that binds the 4-1BB receptor and activates its signaling.

The treatment is currently being tested, alone or in combination therapies, in both solid (NCT02554812 and NCT02315066) and blood cancers (NCT01307267 and NCT02951156).

In preclinical studies, this investigational therapy enhanced T-cell mediated anti-cancer immune responses. Research suggests that utomilumab could potentially increase the proliferation and activity of Yescarta, which is composed of engineered T-cells.

The new Phase 1/2 trial will test the best combination for these therapies and determine whether utomilumab actually enhances the effects of Yescarta.

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