Bristol Myers Squibb reported a major breakthrough in the treatment of relapsed or refractory multiple myeloma (RRMM).

 

The global pharma powerhouse has announced that its investigational CELMoD therapy mezigdomide cut myeloma progression risk by 52% in a Phase 3 study.

 

The study delivered a median progression-free survival of 18 months for patients receiving MeziKd, more than double the 8.3 months achieved with standard therapy, marking the first positive Phase 3 results for a CELMoD agent.

 

"The combination of MeziKd demonstrated a promising median progression-free survival rate of 18 months in multiple settings of relapsed, refractory multiple myeloma, along with a consistent safety profile and the convenience of oral administration and ability to implement across diverse care settings,” said Paul Richardson, Director of Clinical Research and Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center.

 

“Maintaining durable disease control becomes an increasing challenge with each line of therapy for patients with relapsed or refractory disease and increasing resistance to therapy, so achieving extended progression-free survival of a year and a half is especially meaningful. These promising results at ASCO underscore MeziKd’s potential, particularly for those patients who need additional options after both early and later relapse.”

 

Beyond delaying disease progression, MeziKd delivered stronger response rates across multiple patient groups, including those receiving second- and third-line treatment and patients with higher-risk disease.

 

The overall response rate reached 80.2%, compared with 53.4% for standard therapy. Complete response rates were also markedly higher at 26.7%, versus 8.9%. Median overall survival has not yet been reached.

 

The safety profile remained consistent with previous mezigdomide studies. Grade 3-4 treatment-emergent adverse events occurred in 83.7% of patients receiving MeziKd versus 56.5% in the control arm. Higher rates of neutropenia and infections were observed among patients treated with the mezigdomide combination.

 

For Bristol Myers Squibb, the results represent both a potential new treatment option for multiple myeloma patients and a validation of its targeted protein degradation platform.

 

“Multiple myeloma is a persistent disease and there remains an urgent unmet need for patients as early as first relapse,” said Cristian Massacesi, executive vice president, chief medical officer and head of development, Bristol Myers Squibb.

 

“Importantly, these compelling data further validate our targeted protein degradation platform, and cereblon as a critical therapeutic target in multiple myeloma. Mezigdomide is a very potent, oral CELMoD and we’re committed to bringing it forward as a potential new standard of care for relapsed/refractory multiple myeloma across multiple settings.”

 

The SUCCESSOR-2 trial enrolled 479 patients with relapsed or refractory multiple myeloma, many of whom had already been exposed to or become resistant to multiple classes of therapy. More than 92% were triple-class exposed, highlighting the difficult-to-treat nature of the study population.