At two years, Gilead lymphoma therapy active in 40 percent of patients

SAN DIEGO (Reuters) – Nearly 40 percent of lymphoma patients treated with a single infusion of Gilead Sciences Inc’s Yescarta continued to respond to the cell therapy after at least two years of follow up, the company said on Sunday.

An update presented on Sunday at a meeting of the American Society of Hematology showed that at a median follow-up of 27.1 months, 37 percent of 101 lymphoma patients treated with Yescarta remained in remission.

Yescarta, approved by the U.S. Food and Drug Administration in October 2017 for aggressive large B-cell lymphoma that has not responded to other treatments, is part of a new class known as chimeric antigen receptor T-cell therapies, or CAR-Ts.

The therapy requires extracting white blood cells from an individual patient, altering them in a lab to sharpen their ability to spot and kill cancer cells, and infusing them back into the same patient.

A one-time treatment can mean lasting remission, even for very sick patients, but long-term results are still uncertain.

Gilead’s trial update showed that for patients who had achieved complete remission 12 months after Yescarta treatment, 93 percent remained in remission after two years.

The company said 61 of 101 patients had their lymphoma worsen or died on study. Median overall survival had not yet been reached and 51 trial patients were still alive.

“Outcomes with traditional standard of care for this highly refractory patient population have been extremely poor,” said Dr. Sattva Neelapu, co-lead investigator on the trial and professor of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center in Houston.

CAR-T treatments can cause serious side effects, including a serious inflammatory condition known as cytokine release syndrome (CRS).

In the two-year Yescarta analysis, high-grade CRS and neurologic problems were seen in 11 percent and 32 percent of patients, respectively.

“The two-year point is a another major milestone for Yescarta, which has extended the lives of a significant number of patients,” Alessandro Riva, head of oncology therapeutics and cell therapy at Gilead, said in a statement.