Gilead's Yescarta in line for $1.5B sales in earlier lymphoma thanks to game-changing data, fast production: analyst

Newly unveiled data will likely establish CAR-T therapies as the new standard of care in certain patients with aggressive B-cell lymphoma after one prior therapy. For Gilead Sciences’ Yescarta, that indication could mean $1.5 billion in sales over time.

That’s the projection analysts at RBC Capital Markets made in a Thursday note to clients after speaking with a lymphoma expert.

Yescarta likely won’t get there overnight, as the RBC team sees potential future adoption in second-line large B-cell lymphoma (LBCL) to be “more steady rather than an inflection.”

Christi Shaw, CEO of Gilead’s Kite Pharma, also believes a sales uptick takes time. Kite estimates about 14,000 U.S. patients would be eligible for Yescarta in the second line, compared with 8,000 patients in its currently-approved third line.

“We don’t believe it’s going to be a flood of patients coming all at once,” Shaw said in a recent interview, pointing to the initial slow ramp for CAR-Ts when they were first introduced in 2018. In preparation of a potential expansion into earlier treatment, the company’s priority is making sure that patients and community physicians are aware of Yescarata as an option, she said.

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RBC’s bullish assessment came after detailed data presented at the American Society of Hematology annual meeting confirmed that Yescarta cut the risk of disease progression, death or start of a new therapy by 60.2% over standard of care, which involved high-dose chemotherapy followed by stem cell transplant.

Meanwhile, Bristol Myers Squibb’s rival CAR-T therapy Breyanzi reported a 65.1% risk reduction on a similar event-free survival marker in the same second-line LBCL setting from its own phase 3 trial.

Both those datasets could be game-changing, “a world-renowned physician from a major cancer center who specializes in cell therapy approaches for treating lymphomas” told the RBC team. The analysts expect applications of the drugs in second-line LBCL will face no regulatory hurdles and will lead to increased adoption post-approval.

Yescarta’s Zuma-7 trial and Breyanzi’s Transform studies have some differences. In the Yescarta trial, investigators have followed trial participants for over two years, while Breyanzi’s results came from 6.2 months of follow-up. The Transform trial allowed bridging with chemotherapy before the CAR-T treatment, while Zuma-7 only allowed use of corticosteroids. Still, the lymphoma expert viewed the data as more similar than different, and the RBC team labeled the differences “marginal at best.”

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But the expert did see a difference in how long it takes for the personalized T cell therapies to reach patients. The real-world turnaround timeline for Yescarta tends to be around 17 days, the expert said, whereas Breyanzi takes at least a week longer. On their respective websites, Gilead said real-world data showed a median time of 16 days from blood draw to final product release for Yescarta, while BMS targets a 24-day turnaround for Breyanzi.

Thanks to the faster turnaround, Yescarta could continue to be the “dominantly-used CAR-T, with Breyanzi reserved for patients that are frailer but have more time to wait,” the RBC team said. As Yescarta gains steam, the RBC analysts could see it generating $1.5 billion in the second-line use down the line, they wrote to clients.

As for Novartis’ Kymriah, because it failed in its second-line trial, the RBC team now expects it to concede share to Breyanzi.

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Analysts at Cowen reached a similar conclusion in a September note after Gilead, BMS and Novartis had announced the headline outcomes of their second-line trials. Among 20 lymphoma-treating oncologists Cowen surveyed, 60% selected Yescarta and its sister med Tecartus as their most commonly used CD19 CAR-T product in 2024, versus 25% who chose Breyanzi and 15% for Kymriah.

At that time, experts told Cowen that they would consider Breyanzi mostly in patients who may be frailer and in cases where Yescarata manufacturing slots are limited as a result of increased demand. Yescarata has been linked to a relatively high rate of neurotoxicity, the Cowen team noted.

In the Cowen survey, half of oncologists expect the volume of U.S. lymphoma patients receiving a CAR-T in 2022 to increase by 11% to 30%, while another 20% project an increase of 31% to 50%.