Key Points:
- Gilead CAR-T therapy Anito-Cel shows no delayed neurotoxicities, highlighting a strong safety profile.
- It achieved a 96% overall response rate with rapid minimal residual disease negativity in 95% of patients.
- Long-term survival is promising, with 24-month overall survival at 83%, setting up a competitive 2026 launch.
Gilead Sciences said Saturday that its investigational Gilead CAR-T therapy anitocabtagene autoleucel showed no delayed neurotoxicities and sustained survival benefits in a Phase II study of one hundred seventeen patients with relapsed or refractory multiple myeloma, positioning the treatment for a competitive 2026 launch.
Anito-Cel Maintains Safety Edge in Phase II Study
Updated results from the iMMagine-1 trial, presented at the American Society of Hematology meeting, indicated that patients receiving anito-cel experienced no delayed neurotoxicities such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome. Researchers said the absence of these events strengthens the therapy’s emerging safety profile.
Gilead reported that immune effector cell-associated neurotoxicity syndrome occurred in eight percent of patients, with only one case reaching Grade 3. Cytokine release syndrome appeared in eighty-six percent of participants, though the company said most cases were mild. “The deep, durable responses seen with iMMagine-1, combined with a predictable and manageable safety profile, highlight Gilead CAR-T therapy anito-cel’s potential to redefine care,” said Cindy Perettie, executive vice president of Gilead’s Kite unit.
Several physicians tracking the trial said the findings may give Gilead CAR-T therapy anito-cel an advantage over Johnson & Johnson’s approved CAR-T therapy Carvykti. One key opinion leader previously told FirstWord that the absence of delayed neurotoxicities was “pretty remarkable” for the field.
Strong Responses and Sustained Survival Rates Reported
The therapy produced an overall response rate of ninety-six percent, with seventy-four percent of patients achieving stringent complete responses or complete responses. Median progression-free and overall survival have not been reached.
Gilead disclosed new eighteen- and twenty-four-month data showing progression-free survival rates of 67.4 percent and 61.7 percent. Overall survival rates were 88 percent and 83 percent, respectively. The company said patients typically responded quickly, with a median time to complete response of just over three months.
Among ninety-six patients evaluable for minimal residual disease testing, ninety-five percent reached minimal residual disease negativity within a median of one month. Investigators said these findings reinforce the therapy’s potential durability.
Analysts Watch Competitive Landscape Ahead of 2026 Launch
Anito-cel is expected to compete directly with Carvykti, which has dominated the multiple myeloma CAR-T market since approval. Analysts said safety differentiation could influence physician decision-making as more treatments enter late-stage development.
Industry observers also noted that Gilead CAR-T therapy manufacturing appears rapid and consistent, a key factor in CAR-T accessibility. Gilead said production timelines remain stable, which could support broader commercial uptake once approved.
Regulatory submissions are anticipated in 2026, pending additional follow-up from iMMagine-1. Neither Gilead nor Arcellx disclosed further launch details at the meeting.
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