Bristol Myers Squibb’s Zenbexus Delivers Major Blood Cancer Win, Cuts Progression Risk 51%

Bristol Myers Squibb & Co. (NYSE:BMY) announced topline results from its Phase 3 EXCALIBER-RRMM study on Thursday.

The pharmaceutical company revealed its drug Zenbexus (iberdomide) significantly reduced the risk of disease progression or death in multiple myeloma patients.

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Multiple myeloma is a rare blood cancer that starts in plasma cells, a type of white blood cell found in the bone marrow that normally makes antibodies to fight infections.

Evaluating the Efficacy Of ZENBEXUS

The late-stage clinical trial tested Zenbexus alongside daratumumab and dexamethasone (ZDd).

Researchers evaluated 800 individuals suffering from multiple myeloma, treating patients who were experiencing their first relapse.

Significant Survival Rates Achieved

The trial data showed a major, statistically significant improvement in progression-free survival. Patients receiving the ZDd regimen achieved a median progression-free survival of 42 months.

In contrast, those taking the standard daratumumab, bortezomib and dexamethasone (DVd) combination only reached 20 months.

This outcome translates to a 51% drop in the risk of death or disease progression.

Researchers recorded a median follow-up time of 23 months for the study. Additionally, the safety profile for ZENBEXUS paired with standard treatments mirrored earlier safety findings from the trial.

Expanding On Previous Regulatory Success

Thursday’s data builds upon earlier trial achievements.

The company previously reported improvements in minimal residual disease-negative complete responses compared to the DVd regimen.

In August, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Zenbexus for adult patients with multiple myeloma.

The approval is for use in combination with daratumumab, hyaluronidase-fihj, and dexamethasone (ZDd) for patients who have undergone at least one prior therapy line, including a proteasome inhibitor and an immunomodulatory agent.

This made Zenbexus the first FDA-approved CELMoD, a novel class of cereblon-modulating protein degraders.

Analyst View

William Blair on Thursday wrote, “We still expect Zenbexus to see utilization, particularly in community practices where access to CAR-T and bispecifics may be more limited; oral Zenbexus can be combined with Darzalex, and avoids the CRS and neurotoxicity risk and related monitoring requirements of T-cell redirecting therapies.”

BMY Price Action: Bristol-Myers Squibb shares were down 1.41% at $58.86 at the time of publication on Thursday, according to Benzinga Pro data.

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