Bristol Myers flunks frontline multiple myeloma trial, turning attention to cell therapy
Celgene and Bristol Myers Squibb may have combined forces, but their latest mix of multiple myeloma treatments don’t appear to be a good match.
Bristol Myers announced that its Phase III trial combining the BMS drug Empliciti — co-developed with AbbVie — with Celgene’s long-running blockbuster Revlimid had failed. The cocktail did not help first-line patients hold off cancer progression for longer than just Revlimid alone. (Both treatment arms were also given the steroid dexamethasone.)
The two NJ-based companies have used their treatments in combination since well before the merger. Celgene catapulted itself into the small circle of Big Pharmas by turning the famous birth defect-causing drug thalidomide into some of the first effective multiple myeloma treatments. And when Empliciti was first approved in 2015, it was combined with Revlimid and dexamethasone for patients who had received 1 to 3 therapies. The latest approval, in August, was for Empliciti in combination with another Celgene drug, Pomalyst, for relapsed or refractory treatment.
Bristol Myers, though, has failed to get it approved for first-line treatment, which could have substantially bolstered its market. In just the last quarter of 2019, Revlimid had $2.2 billion in sales, compared with $150 million for Empliciti.
At least in this roughly 750-person trial, however, adding Empliciti didn’t help stave off tumor progression. The company only announced that the primary endpoint, PFS, had failed and that the adverse effects were consistent with previous trials. They have not yet released data on secondary endpoints, including response rate and overall survival.
For Bristol Myers Squibb, attention now turns to two alternate approaches to multiple myeloma. Another bid for Empliciti involves combining it with their PD-1 inhibitor Opdivo.
More prominently, there is the cell therapy they picked up from Celgene, known as ide-cel. Co-developed with bluebird, the treatment would be the first CAR-T therapy indicated for multiple myeloma. In December, Bristol-Myers and bluebird unveiled data showing that, across 128 relapsed or refractory patients, 73% responded to the therapy and just under a third had a complete response. The response lasted for a median of 11.3 months.
The companies haven’t filed for an NDA yet, but analysts expect an approval in late 2020 or early 2021. It is one of the three Celgene drugs that have to get approval to activate the $9 contingent-value-rights agreement from the merger, alongside a lymphoma cell therapy called liso-cel and a multiple sclerosis drug called ozanimod.