Bristol Myers Squibb & Co released topline data Monday from its Phase 2 TRANSCEND FL trial of Breyanzi (lisocabtagene maraleucel) for relapsed or refractory indolent B-cell non-Hodgkin lymphoma.

The study met its primary endpoint in the marginal zone lymphoma (MZL) cohort and Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients. It also met the key secondary endpoint of complete response rate (CRR).

Also Read: Bristol Myers Squibb Warns Near-Term Impact Due To Generics On 2025 Sales Forecast, Outlines $2 Billion In Additional Cost Cuts

Breyanzi demonstrated durable responses and a consistent safety profile with no new safety signals observed.

This study marks the fifth cancer type in which Breyanzi has demonstrated clinically meaningful benefit.

In May, the FDA approved Breyanzi for relapsed or refractory mantle cell lymphoma (MCL) for patients who received at least two prior lines of systemic therapy.

This FDA approval marks the fourth distinct subtype of non-Hodgkin lymphoma for which Breyanzi is approved, making it the CAR T cell therapy available to treat the broadest array of B-cell malignancies.

Soon after, the FDA granted accelerated approval to Breyanzi for relapsed or refractory follicular lymphoma. 

In 2024, Breyanzi sales more than doubled to $747 million.

In 2024, U.S. District Judge Jesse Furman of the U.S. District Court for the Southern District of New York dismissed a $6.4 billion lawsuit against issuer Bristol-Myers Squibb ( BMY ). The plaintiff, UMB Bank, had not been properly appointed as the trustee for the securities and therefore lacked standing to sue on behalf of the directing holders.

The issue undermined the lawsuit, filed 17 months after Bristol Myers acquired Celgene for $80.3 billion in 2019.

Price Action: BMY stock is down 2.87% at $55.22 at last check Monday.

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