A cell therapy from Gilead Sciences helped patients with an aggressive form of lymphoma live longer than standard treatment in a major clinical trial, adding to evidence supporting its use earlier in a patient’s disease course.
In a statement Tuesday, Gilead’s cell therapy unit, Kite, said that the treatment, Yescarta, led to a statistically significant improvement in survival versus typical care in a Phase 3 study called ZUMA-7. Kite didn’t provide specifics, but said that Yescarta outperformed a combination of high-dose chemotherapy and a stem cell transplant in adults whose large B-cell lymphoma is relapsed or refractory within a year of receiving initial treatment. The details will be presented at a future medical meeting, the company said.
The results add to a growing body of evidence showing that so-called CAR-T treatments — made from a patient’s own immune cells — can benefit patients with certain blood cancers in earlier lines of care.
Since 2017, multiple treatments, including Yescarta and Bristol Myers Squibb’s Breyanzi, have been approved for lymphoma patients who have essentially run out of options. More recently, Yescarta and Breyanzi have been tested against regimens that have been the standard care for lymphoma patients for decades. Both proved they could cut the risk of disease worsening, progression or death in clinical testing, results that were major proof points for CAR-T drugs and led to approvals in second-line settings last year.
The approvals significantly increased the number of people eligible for the therapies, and sales of Gilead’s drug, in particular, have since taken off, with Yescarta reaching a total of about $1.2 billion last year.
Until Tuesday’s announcement, though, the studies hadn’t definitively shown the therapies can extend lives, the gold standard for a cancer medicine. Kite’s ZUMA-7 study, which began in early 2018, now has the first such evidence. The study was the first and largest Phase 3 trial of a CAR-T treatment, enrolling 359 patients through 77 centers in the U.S., Canada, Europe, Israel and Australia. Participants had either relapsed or seen their cancers become resistant to first-line chemotherapy. Close to a third were over 65 years of age.
The “event-free survival” results that previously led to its second-line approval showed that, after two years, 40% of Yescarta-treated patients were alive and hadn’t seen their cancer progress or needed additional treatment, versus only 16% of those treated with chemo and a transplant.