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Overall survival with oral selinexor plus low-dose dexamethasone versus real-world therapy in triple-class-refractory
Paul G Richardson1, Sundar Jagannath2, Ajai Chari3
1Jerome Lipper Multiple Myeloma Center Department of Medical Oncology Dana-Farber Cancer Institute Harvard Medical School Boston Massachusetts.
Abstract:
Triple-class-refractory multiple myeloma (MM) describes MM refractory to proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies. In the Phase IIb STORM study (NCT02336815), oral selinexor plus low-dose dexamethasone (Sel-dex) demonstrated a 26.2% overall response rate in triple-class-refractory MM. Here, we compare overall survival (OS) of 122 patients with triple-class-refractory MM who received Sel-dex in STORM Part 2 with that of 64 similar patients treated with other available therapies in a Flatiron Health Analytic Database (FHAD) cohort. OS from the date that the patients' MM became triple-class-refractory was longer in STORM versus FHAD, with an unadjusted hazard ratio (HR) of 0.43 (P = .0002; adjusted HR 0.35 [P = .011]). In a subset analysis of highly resistant patients receiving further therapies after their MM first became at least triple-class-refractory (i.e., who received Sel-dex in STORM, n = 64, and non-Sel-dex in FHAD, n = 36), the OS was significantly longer in STORM with an unadjusted HR of 0.52 (P = .0331; adjusted HR 0.33 [P = .041]). Within the limits of this analysis, the OS of patients with at least triple-class-refractory MM was significantly better with Sel-dex versus available therapies, suggesting that Sel-dex may be associated with a meaningful OS benefit in these patients.
Insights
Oral selinexor plus dexamethasone (Sel-dex) showed improved overall survival for patients with triple-class-refractory multiple myeloma (MM). This finding suggests Sel-dex offers a significant survival benefit in heavily pretreated MM patients.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Triple-class-refractory multiple myeloma (MM) is defined by resistance to proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.
- Existing treatment options for this advanced MM stage are limited, necessitating novel therapeutic approaches.
Purpose of the Study:
- To compare the overall survival (OS) of patients with triple-class-refractory MM treated with oral selinexor plus low-dose dexamethasone (Sel-dex) versus other available therapies.
- To evaluate the efficacy of Sel-dex in a challenging patient population with limited treatment history.
Main Methods:
- A comparative analysis was conducted between patients from the Phase IIb STORM study (Part 2) receiving Sel-dex and a real-world cohort from a Flatiron Health Analytic Database (FHAD) receiving other therapies.
- Overall survival was measured from the date of diagnosis of triple-class-refractory MM.
Main Results:
- Patients treated with Sel-dex in the STORM study demonstrated significantly longer OS compared to the FHAD cohort (unadjusted HR 0.43, P=.0002; adjusted HR 0.35, P=.011).
- In a subset of highly resistant patients, Sel-dex treatment was associated with a significant OS improvement (unadjusted HR 0.52, P=.0331; adjusted HR 0.33, P=.041).
Conclusions:
- Sel-dex treatment was associated with a statistically significant and clinically meaningful improvement in overall survival for patients with triple-class-refractory multiple myeloma.
- These findings support the potential of Sel-dex as an effective therapeutic option for patients with advanced, refractory MM.
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