Gilead, Novartis tout long-term data for CAR-T slow starters Yescarta, Kymriah

Gilead and Novartis are working to ramp up launches of their slow-starting CAR-T drugs, and both companies are hoping longer-term follow-up data will help do the trick.

Sunday at the American Society of Hematology (ASH) annual meeting, Gilead’s Kite unit rolled out two-year data from the Zuma-1 study that won Yescarta its October 2017 approval in relapsed or refractory large B-cell lymphoma. Results showed that at a median 27.1 months of follow-up, 39% of patients were still responding after one infusion of the drug. And what’s more, median overall survival hadn’t yet been reached.

"The fact that we’re even having a two-year analysis in this patient population is quite remarkable," Jeff Wiezorek, Kite’s SVP of clinical development, said, noting that "the patient population that we’ve treated was extremely sick."

The way Wiezorek sees it, the data "will be really compelling to a lot of the community" of physicians Kite will need to win over if it hopes to kick Yescarta into high gear.

"When we first showed our initial results, they said, ‘The results were incredible, but we need to see the one-year data,’" and after Kite came through with the one-year data, doctors wanted to see two-year data, he said.

Of course, expanding the CAR-T market will depend on more than just prescriber confidence. Between Yescarta and Novartis’ Kymriah, the pricey and complex CAR-T drugs have run into both reimbursement challenges and manufacturing woes since Novartis won the field’s first FDA nod, in acute lymphoblastic leukemia.

Speaking of Kymriah, Yescarta wasn’t the only CAR-T drug to post positive long-term lymphoma data at ASH. Saturday, Novartis said the median duration of response to Kymriah hadn’t been reached at the 19-month mark in its Juliet study, "indicating most responders were still experiencing a response at the time of analysis."

Gilead, though, doesn’t seem too worried that Novartis is on its tail after the Swiss drugmaker’s May approval for Kymriah in relapsed or refractory diffuse large B-cell lymphoma.

"I think our numbers speak for themselves, and we’re fortunate to have the longest duration of follow-up," Wiezorek said, adding, "We’re the only ones with a two-year analysis."

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