The European Commission has granted full marketing authorization to selinexor (Nexpovio) in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.
This decision follows a positive opinion from the European Medicines Agency's Committee on Medicinal Products for Human Use in May 2022, converting the conditional marketing authorization for selinexor into full approval.
This approval is supported by results from the Boston Phase 3 study (NCT03110562), in which the combination (n = 402) resulted in a median progression-free survival (PFS) of 13.93 months (95% CI, 11.73–non-evaluable [NE]) in this population, compared to 9.46 months in the bortezomib plus dexamethasone monotherapy group (n = 207) (HR, 0.70; 95% CI, 0.53–0.93; P = .0075).
As of the data cutoff date of February 18, 2020, 19% of patients in the selinexor group and 17% of patients in the control group were still receiving treatment. The majority of patients in both groups discontinued treatment due to disease progression, at 34% and 52%, respectively.
In the selinexor group, the median follow-up was 13.2 months (interquartile range [IQR], 6.2–19.8); the median follow-up in the control group was 16.5 months (IQR, 9.4–19.8 months).
Additional findings indicated that the selinexor combination achieved an ORR of 76.4% (95% CI, 69.8%–82.2%), compared to 62.3% (95% CI, 55.3%–68.9%) in the control group (odds ratio [OR], 1.96; 95% CI, 1.3–3.1; P = .0012). More patients in the study group achieved very good or better partial responses compared to the control group (OR, 1.66; 95% CI, 1.1–2.5; P = .0082).
Furthermore, the median time to first response (IQR) in the selinexor combination was 1.1 months (IQR, 0.8–1.6), compared to 1.4 months in the control group (IQR, 0.8–1.6). The median hazard ratios for the study group and the control group were 20.3 months (95% CI 12.5–NE) and 12.9 months (95% CI 9.3–15.8), respectively (hazard ratio 0.81; 95% CI, 0.56–1.17; P = .1364). Additionally, patients treated with selinexor were reported to have a longer median time to next treatment compared to those who did not receive selinexor, at 16.1 months and 10.8 months, respectively (HR, 0.66; 95% CI, 0.50–0.86; P = .0012).
Regarding safety, investigators evaluated 195 patients in the selinexor group and 204 patients in the control group. The most common grade 3 or 4 toxicities associated with this regimen include thrombocytopenia, anemia, pneumonia, and fatigue. These side effects are more frequent with the selinexor regimen compared to the control regimen.
