With the goal of becoming a powerhouse in oncology, Gilead Sciences is closely tracking the progress of its two marketed CAR-T therapies.
Armed with its CAR-T unit Kite Pharma and FDA-approved therapies Yescarta and Tecartus, the company has a pulse on the hot market and has identified some factors hampering cell therapy growth in the U.S.
This past quarter, Kite’s cell therapies Yescarta and Tecartus delivered sales gains of 23% and 18%, respectively. Tecartus pulled down $96 million, while Yescarta generated $391 million but missed analyst estimates of $417 million, according to Third Bridge analyst Lee Brown.
On Gilead's quarterly conference call Tuesday, Chief Commercial Officer Johanna Mercier said it was “surprising” that only about 10% of eligible second-line large B-cell lymphoma patients are undergoing cell therapy treatment “given the strong clinical data."
Describing the situation, Kite’s new head Cindy Perettie attributed the gradual uptake to “specific barriers” that mainly exist in the U.S. market.
While uptake has been faster in Europe due to “socialized medicine” systems that allow patients quicker access after reimbursement talks, the U.S. is hampered by “the fragmentation of the healthcare system,” Perettie said.
Around 80% of oncology patients are treated in their local communities, Perettie explained, but most of the company's authorized treatment centers "exist in large academic hospitals."
In response, the company is growing its roster of treatment centers in an effort to “treat patients where they are," she added.
Gilead is looking to end the year with some 140 authorized treatment centers in the U.S., and the number "will continue to grow in 2024," Perettie said.
Despite the hurdles, the company sees “significant opportunity” to drive growth in CAR-T adoption. The company maintains that Kite is in a good spot to benefit from overall cell therapy expansion due to its data and “industry-leading” manufacturing capabilities, which offer a 16-day median U.S. turnaround time, according to Mercier.
For future CAR-T launches, such as the Arcellx-partnered CART-ddBCMA, Gilead thinks it will have manufacturing ready to roll thanks to its “Yescarta learnings," Perettie said. Overall, the company aims to be “significantly better” than it was during Yescarta's launch, she added.
The molecule is being evaluated in multiple myeloma. Despite the recent launches of new FDA-approved medicines, the company believes there’s “enough room … to have multiple competitors,” Perettie said.
Overall, Gilead's $6.99 billion in third-quarter revenue came in flat versus the same period in 2022. Excluding COVID treatment Veklury, Gilead's sales grew by 5%.