Add-on treatment with mezigdomide significantly delayed cancer progression among people with hard-to-treat myeloma in a Phase 3 clinical trial, according to interim data announced by the experimental oral therapy’s developer, Bristol Myers Squibb.
“We are excited by these results, which underscore Bristol Myers Squibb’s leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease,” Cristian Massacesi, MD, executive vice president, chief medical officer, and head of development at Bristol Myers Squibb, said in a company press release.
Mezigdomide targets molecular pathways to kill cancer cells
The Phase 3 SUCCESSOR-2 trial (NCT05552976) enrolled more than 500 people with relapsed or refractory myeloma, meaning the disease came back following initial lines of treatment or failed to respond. All participants received the standard myeloma therapies Kyprolis (carfilzomib) and dexamethasone. Some received this two-drug combo only, while others were also given add-on mezigdomide. The study was open-label, meaning participants knew whether they were receiving the experimental drug.
The main goal of the trial was to show that add-on mezigdomide would lead to a significant improvement in progression-free survival (PFS), or the time patients remain alive without their disease worsening. According to Bristol Myers Squibb, which sponsored the study, interim data showed a “statistically significant and clinically meaningful improvement” in PFS for patients given add-on mezigdomide.
“It is important for patients to have treatment options that offer enduring disease control,” said Meletios-A. (Thanos) Dimopoulos, MD, of National and Kapodistrian University of Athens in Greece. “These positive interim data show that adding mezigdomide … to [Kyprolis] and dexamethasone may provide clinical benefit in earlier relapse.”
Bristol Myers Squibb said that safety data from the Phase 3 study were “consistent with the known profile of mezigdomide and the [Kyprolis/dexamethasone] combination regimen,” and added that the study is still ongoing and will track long-term safety and survival outcomes. The company’s announcement didn’t include specifics on PFS or safety outcomes, noting that detailed results will be presented at an upcoming scientific meeting and shared with regulatory authorities.
Mezigdomide is an investigational oral therapy that belongs to a class of medicines called CELMoDs (Cereblon E3 Ligase Modulators), which aim to kill myeloma cells by interfering with molecular pathways essential to their survival. Massacesi said the results from the SUCCESSOR-2 study “reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond.”
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