Gilead Sciences (NASDAQ:GILD) is preparing for a potential launch of its multiple myeloma cell therapy anito-cel, with plans to build on the treatment-center relationships and manufacturing capabilities established by its existing CAR-T products, a company executive said.
Cindy Perettie, executive vice president of Gilead’s Kite unit, said the company expects to have 200 authorized treatment centers in the U.S. for anito-cel. The drug has a December 23 regulatory decision date, she confirmed during a discussion hosted by Wolfe biopharma analyst Alex Hammond.
Perettie described anito-cel as Kite’s next major growth driver, while noting that its existing lymphoma therapies, YESCARTA and TECARTUS, continue to face competition. Gilead’s initial planned launch is in patients who have received at least three prior lines of treatment.
Launch targets and manufacturing
Although Kite works with the 200 centers today, Perettie said it cannot complete contracts to add anito-cel until the product has a label. Centers will also need to add the ordering system to their electronic medical records and put the treatment on their formularies, while payer reimbursement will be another factor in uptake.
Kite expects 80% of the authorized centers to come on board within six months and 90% of payers to reimburse the therapy within the first year. Perettie said the company’s goal is to achieve brand leadership within 18 months.
“The things that were barriers in the past,” including manufacturing slot availability, should not be hurdles in the future, she said. Kite has enough manufacturing capacity to support YESCARTA, TECARTUS and anito-cel beyond its initial launch and into earlier treatment settings, according to Perettie.
She said Kite’s commercial products currently have turnaround times of two to three weeks, which the company expects to match for anito-cel. Kite has reported 97% manufacturing reliability for YESCARTA and TECARTUS and had published a 99% figure for anito-cel, although she cautioned that the latter could change as volumes increase.
Data and earlier-line opportunity
Perettie said Kite plans to present updated iMMagine-1 trial data at the American Society of Hematology meeting, including efficacy, safety and progression-free survival results with a minimum of 18 months of follow-up. She cautioned that the progression-free survival data remain immature beyond that period.
More than 400 patients have received anito-cel across the phase 1, iMMagine-1 and iMMagine-3 studies, she said. Perettie said the rate of grade 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome remained below 1%, and that Kite continues to have confidence in the treatment’s safety profile.
The iMMagine-3 study, which is evaluating anito-cel in earlier lines of treatment, completed enrollment in June ahead of schedule. Perettie said 2027 is the earliest the company could submit for an earlier-line indication. The trial has co-primary endpoints involving minimal residual disease and complete response rates, as well as progression-free survival.
Perettie said the company sees safety and the ability to treat patients in community settings as important to expanding CAR-T use in earlier lines. Most of Kite’s current authorized centers are academic institutions, though about 25 are community practices, she said.
Autoimmune research and pipeline
Beyond multiple myeloma, Perettie said Kite is studying cell therapies in autoimmune diseases. She said patient deaths reported elsewhere in the field were unfortunate, but that Kite had not observed the same outcome in its programs.
The company has a CD19/CD20 program with basket trials in rheumatology and neurology, and anito-cel is being studied in myasthenia gravis and myositis. The phase 1 myasthenia gravis study is nearly fully enrolled, she said.
Kite is also building an in vivo cell therapy portfolio and studying candidates for lymphoma and solid tumors, including hepatocellular cancer and glioblastoma. Perettie said anito-cel remains the principal near-term growth opportunity.
About Gilead Sciences (NASDAQ:GILD)
Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops and commercializes medicines for serious diseases. Founded in 1987 and headquartered in Foster City, California, the company focuses on antiviral therapies, including treatments and preventive medicines for HIV and medicines for viral hepatitis. Its products include Biktarvy for HIV and Epclusa for hepatitis C. Gilead also develops medicines in areas such as oncology and inflammatory diseases. Its portfolio includes Veklury (remdesivir), an antiviral medicine used to treat COVID-19.
