Gilead undeterred in oncology despite CAR-T growth slowdown, Trodelvy trial miss

Despite markedly slower cell therapy growth from the third to the fourth quarter of 2023—and a recent setback for Trodelvy—historically HIV-focused Gilead Sciences is not discouraged amid its oncology push.

Most recently on Gilead's quest to become a major oncology player, the company scored an FDA nod for a new manufacturing process change for its CAR-T drug Yescarta, shortening the production timeline from seven to five days and allowing for a median turnaround time of 14 days.

The improvement puts Gilead's cell therapy manufacturing ahead of its peers and is “just the beginning of what we can continue to do with this business,” Chief Financial Officer Andrew Dickinson said Tuesday on Gilead’s fourth-quarter and full-year conference call.

Besides Gilead's advantage on turnaround timelines, industry-wide supply challenges in viral vector manufacturing are “something we are not suffering from," Cindy Perettie, executive vice president of Gilead's cell therapy group Kite Pharma, added on the call. That's because the company runs its own viral vector manufacturing facility, she explained.

A recent Kite Pharma restructuring, meanwhile, should “continue to drive growth and efficiency” over the long run, Dickinson said. The company recently cut 7% of its workforce but added 90 roles, netting out to around a 5% overall reduction, a Gilead spokesperson told Fierce Biotech.

“We’re really growing the business for long-term sustainability and growth and less near-term profitability,” Dickenson said, adding that it's “certainly exciting” that the franchise is doing “as well as it is.”

During the fourth quarter, cell therapies Yescarta and Tecartus increased sales (PDF) 11% to $466 million, a slower growth rate than the 22% jump seen during quarter three.

Gilead previously noted that a major barrier in CAR-T uptake can be attributed to a mismatch between where the majority of oncology patients are treated and where the company’s authorized treatment centers (ATCs) operate, which is largely in major academic centers. The constraints within the ATC footprint marked a contributing factor to the fourth-quarter growth downturn, Perettie said.

In response, Gilead aims to expand the footprint of treatment centers, which currently total 400, to “meet patients where they are.” While the effort is a key aspect to Gilead's cell therapy business strategy, it takes “a little bit longer,” meaning growth is likely to be flat to slightly up in the first quarter of 2024 and return during the second half of the year, Perettie noted.  

Another major drug in Gilead’s oncology franchise is the antibody-drug conjugate (ADC) Trodelvy. That drug saw sales skyrocket by 56% over the full year and is a key driver for the company. Still, it took a blow last month with a failed study called EVOKE-01 in previously treated metastatic non-small cell lung cancer (NSCLC).

Despite the missed endpoint, the company still looks to push forward in the front-line NSCLC setting with its EVOKE-03 trial. Gilead maintains a “very high” level of overall confidence in Trodelvy and its development program, Chief Medical Officer Merdad Parsey, M.D., Ph.D., said.

Several phase 3 readouts are planned for this year, including a bladder cancer confirmatory study and an update to a triple-negative breast cancer trial. The full data set from the ill-fated EVOKE-01 study “maintains our level of enthusiasm” about the therapy’s long-term potential on the efficacy and safety side, Parsey added.

Overall, Gilead aims to pull a third of its revenue from the oncology sector by 2030. In 2023, the number was around 11%.

Outside of oncology, Gilead can typically lean on its stalwart HIV franchise. The company’s HIV meds took home the bulk of the bacon last year despite a 2% sales dip in the fourth quarter. In HIV, “you really need to focus on the full year” to track growth trends, Dickinson said. The franchise's yearly sales increase was 6%, reaching a total of $18.2 billion.

Overall, Gilead’s full-year revenues totaled $27.1 billion, a 1% decline from the prior year. Excluding COVID antiviral Veklury, product sales grew 7%.

Compared to its M&A-hungry peers, Gilead has been notably less active in that department as of late. Just yesterday, the company confirmed in an email to Fierce Biotech that it was backing out of its Tizona Therapeutics buy option, an opportunity it paid $300 million for in 2020.

Along with its confidence in in-house opportunities, the company will “continue to be opportunistic” about pursuing business development within its three focus areas of virology, oncology and inflammation, and it will look at “later-stage deals," CEO Daniel O’Day said on the call.

For now, Gilead is content with its more than 20 study readouts planned for this year and a lack of upcoming patent expirations. 

“We feel we have everything within Gilead right now to achieve our ambitions over the second half of this decade,” O’Day said on the call.