Objective:

To report on the pause of clinical trials for CD19-directed CAR T therapies by Novartis and Bristol Myers Squibb due to safety concerns.

Approach:

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Key Findings:

• Three patients in Novartis trials died from IEC-HS, prompting a halt in studies, as confirmed by the company.
• Bristol Myers Squibb observed transient and reversible inflammatory events in zola-cel trials, leading to a precautionary pause.

Interpretation:

IEC-HS is a known risk associated with CAR T therapies, and both companies are reviewing safety data with independent boards and health authorities.

Limitations:

• The full extent of the safety concerns and the impact on ongoing trials is still under review, including the review of cases by independent safety boards and health authorities.

Conclusion:

Both companies are monitoring patients already treated and aim to resume trials after completing their safety reviews.

Sources:

• Fierce Biotech
• BioPharma Dive