Dive Brief:
- Bristol Myers Squibb said Monday that a regimen including its experimental protein-degrading drug mezigdomide produced positive results in a late-stage trial of patients with relapsed or refractory multiple myeloma.
- Investigators found that a combination of mezigdomide and two other standard myeloma therapies was associated with a “statistically significant and clinically meaningful improvement” in progression-free survival when compared to treatment with those two other drugs. Bristol didn’t provide specifics, but said that safety findings were “consistent” with the known profile of mezigdomide and the other components of the regimen.
- Mezigdomide is one of several protein-degrading therapies that Bristol Myers acquired in 2019 buyout of Celgene and sees as successors to blood cancer drugs Revlimid and Pomalyst. Another, iberdomide, hit one of its primary goals in a Phase 3 study late last year and is now under review by the Food and Drug Administration.
Dive Insight:
Bristol Myers is approaching a crossroads, as key patents covering two of its top sellers are set to expire soon. The company has sought to reassure investors that it can navigate the tumultuous period ahead, pointing in particular to an upcoming “data-rich” period that could boost its share value.
Some of those important readouts involve medicines Bristol Myers calls “CELMoDs.” These medicines are targeted protein degraders, a class of drugs that work by “tagging” and trashing problematic proteins rather than blocking their activity. Bristol Myers views them as an advance over drugs like Revlimid and Pomalyst, which also degrade proteins. These versions are designed to be more potent than their predecessors and overcome drug resistance.
Bristol Myers is now close to bringing more than one of these drugs to market. Iberdomide could be approved by Aug. 17, and mezigdomide has now followed by hitting a main Phase 3 trial goal. The latest findings "reinforce the value of our CELMoD program and our targeted protein degradation platform," said Cristian Massacesi, the company's chief medical officer and head of development, in a statement.
Monday’s announcement is an “incremental de-risking” for investors ahead of detailed results that’ll be presented at a future medical meeting, wrote RBC Capital Markets’ Trung Huynh. The RBC team described the program in a client note as “modestly overlooked” compared to important coming clinical readouts for Bristol Myers in Alzheimer’s and cardiovascular disease.
Still, the CELMoD program “has potential to be a key long-term growth driver for the company,” added William Blair analyst Matt Phipps. Important to mezigdomide’s prospects specifically is a head-to-head study testing it directly against Pomalyst, which would “support franchise transition,” he added. Data from that trial are expected in 2027.
Analysts are also looking to a study of a third protein degrader, golcadomide, in follicular lymphoma later this year, plus another trial evaluating iberdomide against Revlimid that should produce data in 2029.