Gilead Challenges J&J in $20B Multiple Myeloma CAR-T Market with Promising New Therapy

Gilead Sciences is poised to enter the lucrative multiple myeloma CAR-T market, setting the stage for a fierce competition with Johnson & Johnson's established Carvykti. The pharmaceutical giant is targeting a 2026 launch for its new cell therapy, anitocabtagene autoleucel (anito-cel), which it believes could expand the market through outpatient use and potentially superior safety profile.

Market Dynamics and Growth Projections

The multiple myeloma CAR-T market is projected to reach $15-20 billion by 2034, according to Cindy Perettie, global head of Gilead's CAR-T unit Kite. This forecast surpasses the company's expectations for its current stronghold in lymphoma CAR-T therapies, estimated to grow to $10-12 billion.

J&J's Carvykti has already made significant strides, with sales hitting $963 million last year and expected to surpass the blockbuster threshold in 2023. Analyst estimates place Carvykti's peak sales at around $7 billion by 2030.

Anito-cel's Promising Clinical Data

Gilead's partner Arcellx recently shared updated Phase II data for anito-cel as a fourth-line or later treatment for relapsed or refractory multiple myeloma. The results were impressive:

• 97% overall response rate in 117 patients
• Nearly 70% of patients achieved a complete response
• 95% overall survival rate at 12 months

BMO Capital Markets analyst Evan David Seigerman noted that anito-cel's efficacy appears "at a minimum comparable to Carvykti, with potentially better [overall survival] rates."

Safety Profile and Outpatient Potential

Gilead believes anito-cel may have a significant safety advantage over Carvykti, particularly regarding neurotoxicity. Key safety data includes:

• No reported cases of Parkinsonism, cranial nerve palsies, Guillain-Barré syndrome, or immune-mediated enterocolitis
• Only 1% rate of grade 3 or above cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)

This improved safety profile could enable more widespread outpatient administration, potentially increasing CAR-T adoption among eligible patients. Currently, only 10% of eligible multiple myeloma patients receive CAR-T therapy.

Gilead is actively pursuing outpatient administration, with 10% of patients in the Phase II trial receiving anito-cel in an outpatient setting. The company has increased this proportion to 20% in its ongoing Phase III trial.