Bristol Myers Squibb Announces CELMoD Mezigdomide Reduces Risk of Disease Progression or Death by More than 50% vs. Standard of Care in Relapsed or Refractory Multiple Myeloma

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced positive late-breaking results from the Phase 3 SUCCESSOR-2 trial (NCT05552976) of CELMoD (cereblon E3 ligase modulation) mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). Results showed MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd.

$BMY announces first Phase 3 results evaluating its investigational therapeutic class called CELMoD for patients with relapsed or refractory multiple myeloma at #ASCO26.

Share

These data, representing the first Phase 3 results for mezigdomide, are being presented in a late-breaking oral presentation (#LBA7506) at the 2026 American Society of Clinical Oncology (ASCO^®) Annual Meeting.

"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, MD, Director of Clinical Research and Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center, the Dana-Farber Cancer Institute and RJ Corman Professor of Medicine, Harvard Medical School. “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.”

Results also showed significantly improved PFS rates with MeziKd across patients in second- and third-line as well as those with higher-risk disease. Higher overall response rate (80.2% vs 53.4%) and complete response or better (26.7% vs 8.9%) were also seen with MeziKd. Median overall survival was not yet reached. The safety profile of MeziKd was consistent with the known profile of mezigdomide and the combination regimen. Grade 3-4 treatment-emergent adverse events were seen in 83.7% vs 56.5% of patients, with neutropenia in 61.1% vs 9.1%, and infections in 34.0% vs 15.6% of patients treated with MeziKd and Kd, respectively.

“Multiple myeloma is a persistent disease and there remains an urgent unmet need for patients as early as first relapse,” said Cristian Massacesi, MD, 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.”

Results from SUCCESSOR-2 will be shared with health authorities. Bristol Myers Squibb thanks the patients and investigators involved in this clinical trial.

About SUCCESSOR-2
There is a growing number of patients exposed and/or refractory to lenalidomide and anti-CD38 antibodies from first relapse. The SUCCESSOR-2 trial addressed this growing need. SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 2/3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).

The primary endpoint of the Phase 3 portion is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, minimal residual disease negativity, and health-related quality of life.

The mezigdomide dose selected for stage 2 of the study was 1.0 mg. In total, 479 patients (288 MeziKd at 1.0 mg of mezigdomide; 191 Kd) were included in the analysis. Median age was 68 with 25.1% of patients ≥75 years old; median number of prior therapies was 2; 92.1% of patients were triple-class-exposed, with 85.8% refractory to an anti-CD38 monoclonal antibody and 75.8% to lenalidomide; 37.2% were exposed to pomalidomide and 7.3% to anti-BCMA treatment. At data cutoff, median follow-up was 10.6 months with 52.4% (MeziKd) and 31.4% (Kd) of patients still on treatment.

About Mezigdomide
Mezigdomide is an oral CELMoD agent from BMS' targeted protein degradation platform specifically optimized for maximal and rapid degradation of Ikaros and Aiolos target proteins, leading to higher multiple myeloma cell killing and immune stimulation. Early pre-clinical data suggest mezigdomide enhances T cell function and prevents and reinvigorates an exhausted immune system.​ Two ongoing phase 3 trials (SUCCESSOR-1 and SUCCESSOR-2) are evaluating mezigdomide oral combinations vs. standard of care regimens in relapsed or refractory multiple myeloma.

About Targeted Protein Degradation and CELMoD
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered "undruggable." We are the only company that has successfully developed and commercialized protein degrader agents – immunomodulatory drugs (IMiD) which helped establish the current standard of care in the treatment of multiple myeloma. We are building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach allows us to match the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) may not achieve its primary study endpoints or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news