A little less than a year after Gilead Sciences’ Yescarta broke new ground in blood cancer, the CAR-T therapy has hit on a gold standard for oncology meds.
In the late-stage Zuma-7 study, Yescarta helped patients with relapsed or refractory large B-cell lymphoma (LBCL) live longer than historic treatment. In turn, the cell therapy charted a statistically significant improvement on overall survival (OS).
Before Tuesday's announcement, Yescarta has already shown it could stave off disease progression in the same study as a treatment for LBCL after just one prior line of therapy. The CD19-directed CAR-T was pitted against traditional treatment, which involves chemoimmunotherapy and stem cell transplant
Gilead's Kite Pharma said it plans to present data in full at an upcoming medical meeting later this year.
The win comes as a nice addition to Yescarta’s April approval in second-line LBCL. The green light marked a historic moment in the CAR-T saga, which had previously seen the personalized cell therapies confined to late-line treatment. Last spring, RBC Capital Markets analysts predicted the new indication could net Yescarta $1.5 billion in peak sales over time.
The drug was approved on data from Zuma-7, which showed Yescarta cut the risk of disease progression, death or the need for a new therapy by 60.2% versus standard care. Back then, data on patient survival were immature.
Yescarta is duking it out with Bristol Myers Squibb’s own CAR-T Breyanzi, which bagged a broader nod in the same second-line lymphoma indication in late June. The clinical trial supporting Breyanzi's approval is still early in its course and will likely take some time before reading out overall survival data.
Yescarta, approved four years before its BMS rival, is currently leading in sales, where it clinched $1.16 billion in global revenue last year. Breyanzi, first approved in 2021, made just $182 million for all of 2022.