Gilead's Kite earns second-line win for CAR-T Yescarta, setting up a battle over earlier blood cancer patients
Bristol Myers Squibb shook the CAR-T field earlier this month with a breakthrough win in earlier-line blood cancer patients with the promise of changing the paradigm in cell therapy care. Now, older competitor Yescarta is uncorking results of its own in that sought-after population — and this time it actually has some data to show.
Kite’s Yescarta boosted event free survival over a standard of care regimen of physicians’-choice salvage therapy followed by high-dose chemo plus a stem cell transplant in second-line relapsed or refractory large B cell lymphoma patients in a win the drugmaker is calling a “landmark” in CAR-T care, Kite said in a release.
At a two-year check in, patients in the Phase III ZUMA-7 trial dosed with Yescarta posted a 60% relative increase in EFS over standard of care, good for a p-value of 0.0001. The study also hit its secondary ORR endpoint but OS data were still too immature to judge, Kite said.
The study’s investigators were unequivocal about the results, painting the data as a breakthrough win for the CAR-T class in earlier-line blood cancer patients.
“The top-line results of the randomized ZUMA-7 trial paint the picture of a potential paradigm shift in the treatment of large B-cell lymphoma,” study co-leader Frederick Locke said in a release.
The safety results from the study, which enrolled 359 patients across 77 treatment centers, were consistent with prior trials, Kite said, with 6% of patients experiencing a grade 3 or higher cytokine release syndrome. Kite plans to submit the data for regulatory approval in the US and EU later this year and present updated data at an upcoming medical meeting.
It’s a big win for Kite and one that will keep pressure on Bristol Myers, which earlier this month read out data for its own CAR-T, Breyanzi, in second-line LBCL patients.
In that study, dubbed TRANSFORM, Breyanzi beat out physicians’-choice salvage therapy followed by high-dose chemo and a stem cell transplant — what the drugmaker called a “gold standard treatment” — in second-line LBCL patients. Despite being three weeks ahead, Bristol Myers had no data to show at the interim check-in, giving the early leg up to Kite in terms of efficacy.
At the time, Bristol Myers touted the TRANSFORM results as the first time a CAR-T had shown benefit in that population and the only CD19-targeted CAR-T to show benefit in second-line patients. The study included a wide range of potential salvage therapies, including rituximab plus dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP); rituximab plus ifosfamide, carboplatin and etoposide (R-ICE); or rituximab plus gemcitabine, dexamethasone and cisplatin (RGDP).
But now, Yescarta, which also targets the CD19 protein, has matched those results and could set up a frantic market battle to secure earlier-line patients. In the first quarter, Yescarta bagged $160 million in sales with a few years of runway on the market while Breyanzi only launched in Q1.