NEW YORK – Gilead Sciences is drumming up excitement for a new CAR T-cell therapy that it believes could become a best-in-class multiple myeloma treatment and bolster its cell therapy franchise.
Foster City, California-based Gilead's subsidiary Kite is codeveloping the autologous B-cell maturation antigen (BCMA)-directed CAR T-cell therapy anitocabtagene autoleucel (anito-cel) with Arcellx as a treatment for relapsed or refractory multiple myeloma patients. Company executives discussed the latest readout from a Phase II trial of anito-cel during a call on Wednesday to discuss Gilead's third quarter 2024 financial performance, a period during which sales of its existing autologous cell therapies were flat compared to the year-ago quarter.
In the iMMagine-1 clinical trial, anito-cel led to a 95 percent objective response rate in 58 patients after a median follow-up of 10.3 months. The complete response rate was 62 percent, and among patients evaluable for minimal residual disease (MRD) testing, 92 percent achieved MRD negativity after getting anito-cel. The median progression-free survival and overall survival had not yet been reached for anito-cel at the time of the data cutoff.
Gilead and Arcellx announced these top-line data on Tuesday but plan to present detailed findings from a more recent data cutoff during the American Society of Hematology annual meeting next month. The partnered firms will also share data from an earlier Phase I anito-cel trial at ASH. In that study, patients experienced a 30.2-month median progression-free survival after a median follow-up of 38.1 months. The median overall survival was not yet reached.
In May, Gilead and Arcellx announced plans for the Phase III iMMagine-3 clinical trial, pitting anito-cel against investigator's choice of standard of care therapy in this advanced multiple myeloma setting. According to the firms, the first patient in this trial has received a dose of anito-cel that was produced using Kite's manufacturing capabilities.
"The combination of anito-cel's potential best-in-class clinical profile with Kite's leading cell therapy manufacturing has the ability to transform care for a large number of multiple myeloma patients," Gilead CEO Daniel O'Day said during the conference call.
Anito-cel, which the partnered firms call a CART-ddBCMA, involves using Arcellx's D-Domain binder to modify patients' harvested T cells so they target BCMA on multiple myeloma cells. If anito-cel reaches the market, it will join other commercialized BCMA-targeted autologous CAR T-cell therapies for relapsed or refractory multiple myeloma, including Janssen and Legend Biotech's Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb and 2seventy Bio's Abecma (idecabtagene vicleucel). But anito-cel, according to Gilead and Arcellx, is the first cell therapy to use a novel and compact D-Domain binder.
If Gilead is successful in bringing anito-cel to market, it will be the third CAR T-cell therapy in the firm's cell therapy franchise, which includes Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). Over the three months ended Sept. 30, the segment performed unremarkably, with sales totaling $485 million, essentially flat compared to $486 million in Q3 2023.
Sales of Gilead's CD19-directed autologous cell therapy Yescarta, which Kite markets for relapsed or refractory large B-cell lymphoma and follicular lymphoma, dipped 1 percent to $387 million in Q3 2024, from $391 million in the prior year's third quarter. Over the same period, sales of Tecartus, which Kite markets for relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia, inched up 2 percent to $98 million from $96 million.
Gilead Chief Commercial Officer Johanna Mercier blamed US competition from other cell therapies and drugs in other classes for the segment's performance. To combat these headwinds, which Gilead expects to continue into 2025, Mercier said the firm is ramping up efforts to grow these therapies' market share.
"As a pioneer in cell therapy, Kite's focus is to expand overall utilization and increase class share," she said. "As part of this work, we're partnering with government agencies and healthcare associations to amplify education of the benefits of CAR T and remove barriers to access."
As of now, she noted that only two out of every 10 eligible US patients receive CAR T-cell therapy for second-line large B-cell lymphoma. "We are committed to removing these barriers, so we can deliver potentially curative therapies like Yescarta to more patients," she said, noting that Gilead is trying to expand access to its CAR T-cell therapies beyond specialized academic centers and into the community oncology setting.
Beyond the cell therapy franchise, sales revenues of Gilead's TROP2-directed antibody-drug conjugate Trodelvy (sacituzumab govitecan) were $332 million in Q3 2024, up 17 percent from $283 million in Q3 2023. Trodelvy is approved for advanced triple-negative breast cancer and hormone receptor-positive, HER2-negative breast cancer.
According to Mercier, Gilead saw greater uptake of Trodelvy in both of these breast cancer indications. In May, the firm voluntarily withdrew Trodelvy's accelerated approval in metastatic urothelial cancer based on negative data, but according to Gilead, this didn't impact the drug's sales performance in its breast cancer indications.
Gilead is working to advance Trodelvy in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab) in first-line, PD-L1-high metastatic non-small cell lung cancer but is discontinuing development in second- and later-line NSCLC settings following discussions with regulators about data from the EVOKE-01 trial.
For Q3 2024, Gilead's total revenues were $7.55 billion, up 7 percent from $7.05 billion in Q3 2023, and exceeded the average Wall Street revenue estimate of $7.00 billion. The firm's oncology products brought in $816 million, a 6 percent increase from $769 million in the year-ago quarter.
Gilead posted net income of $1.25 billion, or $1.00 per share, in Q3 2024, compared to $2.18 billion, or $1.73 per share, in the prior year's third quarter. Gilead credited the year-over-year dip in net income partly to a pre-tax in-development R&D impairment incurred when acquiring assets in 2020 from Immunomedics, the firm that originally developed Trodelvy.
Non-GAAP diluted EPS was $2.02 during the quarter, beating analysts' average estimate of $1.55 per share.
Gilead estimated that its full-year revenues will fall between $27.80 billion and $28.10 billion, a slight rise from the prior range of $27.10 billion and $27.50 billion. The firm narrowed its EPS expectation to between $.05 and $.25, from $0 to $.30 previously. Adjusted non-GAAP EPS is now expected to be in the range of $4.25 and $4.45, according to Gilead, whereas it was previously expecting adjusted non-GAAP EPS in the range of $3.60 and $3.90.
As of Sept. 30, Gilead had $5.04 billion in cash, cash equivalents, and marketable debt securities.