Selinexor is a drug that is being evaluated for early approval in multiple myeloma for highly relapsed or refractory patients. Dr. Paul Richardson joined the Myeloma Crowd at ASCO to share recent updates on their progress.
Patients in the study had myeloma that was resistant to immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies (also called penta-refractory), representing an urgent unmet medical need with a median overall survival of 3-5 months.
Dr. Richardson noted that in the STORM trial, about 1/3 of patients responded to Selinexor and they were able to compare this group of study patients against another myeloma patient database, eliminating the need for study randomization, where a “watch and wait” or “control” arm in the trial may not be as good. Using the Flatiron database, they found myeloma patients who were in similar circumstances as the patients in the Selinexor arm. They evaluated data showing that patients getting alternative salvage therapies didn’t do very well while the Selinexor patients had encouraging survival. This helps inform both the general research community and the FDA in the company’s request to get early approval.
In the Flat Iron Health Database, 69 patients were identified. Patients in the STORM trial were more heavily pre-treated, had higher risk myeloma, a longer time since diagnosis of myeloma and higher hemoglobin and platelet values. Sixty-four patients received Selinexor after becoming penta-refractory. Median overall survival was 10.4 months for patients receiving Selinexor and 5.2 months in the Flat Iron Health Database patients.
This indicates that penta-refractory myeloma is aggressive and these patients have very few options. It is clear that for these patients, Selinexor may provide double the overall survival compared to what is currently being used.