ASCO: Gilead touts CAR-T franchise with Yescarta analyses, early data on pipeline drug

As other parts of its business slump, Gilead Sciences has zeroed in on cell therapy, hoping to lead a wave into that new market. And at the American Society of Clinical Oncology's (ASCO's) annual meeting Monday, the company touted new info on its approved Yescarta and early data on pipeline up-and-comers.

Yescarta scored FDA approval in 2017 but hasn’t yet taken off in a way that can offset Gilead’s shortfalls in hepatitis C. The cell therapy, approved to treat large B-cell lymphoma after two or more lines of systemic therapy, generated $264 million last year. It's vying against Novartis' Kymriah, which won the first-ever cell therapy approval.

Yescarta's approved indication covers adults with relapsed or resistant disease after at least two previous rounds of treatment. One ASCO analysis delved into how the therapy works in the older segment of those patients—and the answer is, better than in younger folks.

In an analysis of its pivotal Zuma-1 study, patients 65 and older saw a 92% overall response rate at a median 27.1 months, compared with 81% among patients under 65.  Seventy-five percent of the older group achieved a complete response, compared with 53% for those under 65. 

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And at a two-year follow-up, 42% of those 65 and older were still responding to Yescarta, also known as axicabtagene ciloleucel, compared with 38% of those under 65. Further, 54% of the older patients were still alive after that two-year period, compared with 49% in the under-65 group.

The findings are important, co-lead investigator Sattva Neelapu points out, because “patients with refractory large B-cell lymphoma who have exhausted treatment options and are still facing progressive disease are often older.” 

“Our results showed axicabtagene ciloleucel offered clinical benefit with a manageable safety profile in people aged 65 and over, which reinforces this therapy’s use in these patients who otherwise have limited treatment options,” Neelapu said in a statement.

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Gilead also rolled out a new Yescarta safety analysis Monday showing that using steroids soon after Yescarta treatment could help manage cytokine release syndromes and other serious side effects associated with chimeric antigen receptor T-cell (CAR-T) drugs.  

The findings come as Gilead works to build out its cell therapy group after its $12 billion Kite Pharma buy. New Gilead CEO Daniel O’Day, who joined from Roche, has said the technology is a critical component of the company’s strategy.

The drugmaker didn’t only present data on its approved CAR-T drug at ASCO, either. Gilead also rolled out data on an investigational CAR-T called KTE-X19 in adults with relapsed or refractory acute lymphoblastic leukemia. So far in the phase 1/2 trial,  patients have seen a “high rate of response” to a single infusion. The phase 2 portion of the study is ongoing.