CARGO Therapeutics (CRGX) Jefferies London Healthcare Conference 2024 summary

Program overview and clinical progress

• Lead program firi-cel is in a pivotal Phase II study for large B-cell lymphoma patients who have failed CD19 CAR-T therapy, a population with a median overall survival of six months.

• 57 patients have been dosed since September of last year, with a total target enrollment of 101, aiming for interim analysis in the first half of next year.

• The study design closely mirrors those that led to full approvals for similar therapies, with the goal of rapid FDA engagement based on interim results.

• Firi-cel targets the CD22 antigen, offering an alternative for patients who have failed CD19 and CD20 therapies.

Efficacy and safety data

• Stanford Phase I data for firi-cel (CD22 CAR) showed a 52% complete response rate and a median duration of response of 23.2 months in a highly refractory population.

• 75% of patients achieving complete response remained in remission at 12 months, with most still in remission at three years.

• Safety profile is favorable, with lower rates of cytokine release syndrome and no grade 3 neurotoxicity observed.

• Zero grade 3 ICANS is a significant advantage over CD19 CARs, supporting potential use in earlier lines of therapy.

Competitive landscape and market opportunity

• Bispecific T-cell engagers like Roche's CD20/CD3 show initial CR rates of 37–38% post-CAR-T failure, but durable CR drops to 20% at one year.

• Cell therapy is favored by key opinion leaders for its potential for durable response and cure, despite chronic dosing and toxicity challenges with bispecifics.

• The addressable market is significant, as a majority of patients do not achieve durable CR with first CAR-T, and many are eligible for a second CAR-T.