Gilead Challenges J&J in Lucrative Multiple Myeloma CAR-T Market

Gilead Sciences is poised to enter the competitive multiple myeloma CAR-T therapy market, setting the stage for a high-stakes battle with Johnson & Johnson's established Carvykti. The pharmaceutical giant aims to launch its contender, anitocabtagene autoleucel (anito-cel), by 2026, potentially reshaping the landscape of a market projected to reach $15-20 billion by 2034.

Anito-cel's Promising Clinical Data

Gilead's partner Arcellx recently shared updated Phase II data for anito-cel in relapsed or refractory multiple myeloma patients. The results are compelling, with a 97% overall response rate among 117 patients and nearly 70% achieving a complete response. Notably, the 12-month overall survival rate of 95% compares favorably to Carvykti's 89% in a similar study.

The safety profile of anito-cel is particularly noteworthy. As of May 1, no patients in the trial experienced Parkinsonism, cranial nerve palsies, Guillain-Barré syndrome, or immune-mediated enterocolitis – adverse events associated with Carvykti's boxed warning. Additionally, only 1% of patients experienced grade 3 or above cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).

Outpatient Administration: A Game-Changer?

Gilead believes anito-cel's safety profile could be a key differentiator, potentially allowing for outpatient administration. Cindy Perettie, global head of Gilead's CAR-T unit Kite, emphasized that only 10% of eligible multiple myeloma patients currently receive CAR-T therapy, partly due to the need for hospital stays. Gilead has already administered anito-cel to 10% of patients in the Phase II trial in an outpatient setting and plans to increase this to 20% in the Phase III trial.

The company aims to leverage its network of over 550 authorized treatment centers globally, built for its lymphoma CAR-T therapies Yescarta and Tecartus, to support outpatient administration. This approach could significantly expand access to CAR-T therapy, particularly for the 90% of multiple myeloma patients treated in community settings rather than academic centers.

Manufacturing Capabilities: Gilead's Ace in the Hole?

Gilead plans to utilize its existing CAR-T manufacturing infrastructure to produce anito-cel, potentially giving it an edge over competitors. CEO Daniel O'Day highlighted the importance of manufacturing capabilities in CAR-T therapy, citing Gilead's "largest manufacturing network" and "shortest turnaround time" as critical factors in ensuring optimal clinical benefit for patients.

However, J&J is not standing still. The company has already secured FDA approval for Carvykti in second-line treatment and is exploring outpatient administration in ongoing trials. With its established market position and deep pockets, J&J presents a formidable challenge to Gilead's ambitions in the multiple myeloma CAR-T space.

As the battle for dominance in this lucrative market unfolds, patients may ultimately benefit from increased treatment options and potentially improved access to these groundbreaking therapies.