Gilead Sciences is working to move CAR-T therapy Yescarta into other types of non-Hodgkin lymphoma (NHL), and if data from an interim trial look-in are any indication, it’s well on its way.
In a phase 2 study of patients with relapsed or refractory indolent non-Hodgkin lymphoma—which encompasses follicular lymphoma and marginal zone lymphoma—Yescarta spurred a benefit in 93% of patients and cleared cancer completely in 80%, Gilead said ahead of the American Society of Clinical Oncology’s (ASCO's) virtual annual meeting.
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At 15.3 months of follow-up, patients’ responses to treatment had lasted a median 20.8 months, and Yescarta had kept cancer at bay for a median 23.5 months.
The high response numbers aren’t a surprise to the Big Biotech, considering how Yescarta performed in the Zuma-1 study that yielded its FDA approval in the more aggressive relapsed or refractory large B-cell lymphoma field. In that trial, the drug showed it could provoke responses in 83% of patients and erase all signs of cancer in 58%.
“To put that in perspective, those patients under the previous standard of care … had immediate survival of about six months, so that’s a clear achievement and a clear benefit for those patients," Ibrahim Elhoussieny, vice president and head of medical affairs for Gilead’s Kite Pharma, said of the large B-cell lymphoma results. "Based off that, we were hopeful and expecting that level of responses" in indolent NHL, "and we’re very pleased to see that materializing."
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And if Yescarta can keep it up through the study’s primary 12-month analysis, it could soon be on its way to an FDA nod. Gilead said it plans to file for approval in indolent NHL later this year to add to the drug’s slate of indications.
While a green light could make Yescarta the first to market in a new group of treatments for the disease, though, the drug will still "carry significant immune response and neurological safety risks," SVB Leerink analyst Geoffrey Porges wrote in a Friday note to clients. With early data, competing therapies—such as bispecifics and antibody drug conjugates—have shown they can "lower or remove these risks," but as a tradeoff, their response rates are lower, too, in the range of 60% to 80%.
"As these therapies come to market after Yescarta, their solid efficacy, superior safety and convenience, and lower cost are likely to cause the market to split amongst the various therapies based on individual patient preferences rather than one dominant share winner," Porges predicted.
Gilead, which won Yescarta’s first and only nod back in late 2017, is looking to CAR-T to deliver big returns. But, so far, the drug has yet to follow through. It generated $456 million in 2019, but Gilead is hoping to boost that figure with new indications and by moving Yescarta earlier into aggressive NHL treatment.