BMY Wins EC Nod for Label Expansion of CAR T Cell Therapy Breyanzi

Bristol Myers Squibb BMY obtained the European Commission’s (“EC”) approval for a label expansion of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy.

The EC approved Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

The latest approval from the EC marks the fourth approval for Breyanzi in Europe.

Breyanzi is already approved in the EU for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B).

These indications are for patients who relapsed within 12 months of completing, or are refractory to, first-line chemoimmunotherapy; for adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy; and for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

The latest EC approval is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adult patients with relapsed or refractory MCL who had received at least two prior lines of therapy, including a BTK inhibitor.

Results showed that 82.7% of patients responded to Breyanzi, with 71.6% achieving a complete response. Breyanzi demonstrated sustained clinical benefit, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results.

Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.

Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.

BAYRY’s Cardiovascular Data Boosts BMY

Shares of BMY gained 3.3% yesterday after pharma giant Bayer BAYRY announced that pipeline candidate asundexian met primary efficacy and safety endpoints in late-stage OCEANIC-STROKE Study in secondary stroke prevention.

Results from the study showed that asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

Bayer will work with health authorities worldwide to submit marketing authorization applications seeking approval for the candidate.

The positive results from BAYRY raise investors’ hope for the success of BMY’s cardiovascular candidate, milvexian, in secondary stroke prevention.

Shares of Bristol Myers have lost 15.6% year to date against the industry’s growth of 16.5%.

Last week, Bristol Myers and partner Johnson & Johnson JNJ announced the discontinuation of the late-stage Librexia study evaluating the efficacy and safety of pipeline candidate milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event.

BMY and JNJ decided to discontinue the phase III Librexia ACS study following a preplanned interim analysis by the Independent Data Monitoring Committee (“IDMC”).

The IDMC determined that the study is unlikely to meet the primary efficacy endpoint.

Nonetheless, it recommended that the two other late-stage studies — Librexia AF for patients with atrial fibrillation and Librexia STROKE for secondary stroke prevention with milvexian — continue as planned. Top-line data from these studies are expected in 2026.

BMY’s Zacks Rank

BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 

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