Thursday, October 21, 2021

ASH: Gilead’s CAR-T med Yescarta shows promise earlier in lymphoma therapy

Gilead’s Kite Pharma is waiting for phase 3 data that show its Yescarta can help previously treated diffuse large B-cell lymphoma (DLBCL) patients earlier in their treatment course. But in the meantime, it’s trumpeting phase 2 data in newly diagnosed lymphoma patients that it thinks bode well for its forthcoming results.

Over the weekend at the American Society of Hematology (ASH) virtual annual meeting, the company rolled out data showing an infusion of Yescarta could spur a benefit in 85% of high-risk large B-cell lymphoma patients and wipe out cancer completely in 74% of them—a result Ibrahim Elhoussieny, VP and head of medical affairs for Kite, called “outstanding.”

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And at the 9.5-month mark, more than half of patients were still alive and hadn’t seen their cancer worsen.

RELATED: ASH: Novartis makes its Kymriah case in follicular lymphoma, but another Gilead showdown awaits

The results, which come from the Zuma-12 study, are the first to illustrate CAR-T’s promise earlier in lymphoma therapy, where Gilead has long talked up Yescarta’s potential. Right now, the treatment and its archrival—Novartis’ Kymriah—are cleared only in those DLBCL patients who have already failed on two other therapies.

Gilead, though, is intent on changing that, and to do so, it’ll need to chalk up another trial win—this time in phase 3. The Big Biotech is currently trialing Yescarta in second-line patients against the standard of care in that setting: stem cell transplant, with data expected next year.

Importantly, that study, Zuma-7, features overall survival as a key secondary endpoint, meaning that if it succeeds, Gilead will be able to confidently say Yescarta extends the lives of second-line patients.

“The importance there is that we’ll be able to show in a statistically meaningful way how those patients are doing in terms of survival versus the control arm,” Elhoussieny said. Overall survival data are “kind of the gold standard in oncology” and “something that the regulators and the reimbursement bodies eventually … look into,” he added.

RELATED: Gilead sees better days ahead for CAR-T therapy Yescarta with Amsterdam manufacturing hub online

If the Zuma-12 performance does indeed portend a positive Zuma-7 outcome, Yescarta could see much broader use. There are nearly 14,500 addressable second-line DLBCL patients in the U.S., which is almost double the third-line population, according to the company.

In the meantime, though, Yescarta continued to put up impressive third-line numbers at ASH, showing over the weekend that it could keep an estimated 44% of patients alive at the four-year mark post-treatment.

That result “really brings the hope of survival to patients in an unprecedented way,” Elhoussieny said.

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