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

December 19, 2021
Life sciences

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.

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.”

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.

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%.

by Angus Liu

Source: fiercepharma.com

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