Gilead subsidiary Kite Pharma has reported two-year efficacy and safety data of Yascarta in patients with refractory large B-cell lymphoma.
The pivotal ZUMA-1 trial found that with a minimum follow-up of two years after a single infusion of Yescarta, 39% of patients were in an ongoing response.
In October 2017, Yescarta became the first chimeric antigen receptor T (CAR T) cell therapy to be approved in the US for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
At two years, the best objective response via investigator assessment showed an overall response rate of 83%, with 58% of patients having achieved a complete response. With a median follow-up of 27.1 months, 39% of patients remained in response.
Of the patients with an ongoing response at 12 months, 93% remained in response at 24 months.
“With aggressive cancers such as refractory large B-cell lymphoma, our primary goal is to extend the lives of patients,” said Sattva S. Neelapu, ZUMA-1 Co-Lead Investigator.
“Outcomes with traditional standard of care for this highly refractory patient population have been extremely poor. Nearly 40 percent of patients in ZUMA-1 remain in response and half of the patients are still alive after at least two years of treatment with Yescarta.”
In the two-year analysis, Grade 3 or higher CRS and neurologic events were seen in 11% and 32% of patients, respectively, and were generally reversible.
Four patients developed new serious adverse events (occurring since the previous August 11, 2017 data cut-off), none of which were related to Yescarta. No new Yescarta-related CRS or neurologic events or deaths have occurred since the one-year analysis.
The full results have been published in The Lancet Oncology.