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Belantamab Mafodotin shows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse
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BVd, belantamab mafodotin, bortezomib, and dexamethasone; DVd, daratumumab, bortezomib, and dexamethasone; HR, hazard ratio; ITT, intention to treat; NR, not reached; OS, overall survival; R-ISS, Revised International Staging System. a Two patients in the ITT population were randomized, not treated, rescreened, and rerandomized. They are counted as 4 unique patients in this output. b CIs were estimated using the Brookmeyer-Crowley method. c HRs were estimated using a Cox proportional hazards model stratified by the number of lines of prior therapy (1 vs 2 or 3 vs ≥4), prior bortezomib (no vs yes), and R-ISS stage at screening (I vs II or III), with a covariate of treatment. d P value is from a 1-sided stratified log-rank test. At 171 actual events (48.2% OS information fraction), OS was declared significant if the P value was <.00112. (Graphic: GSK)
BVd, belantamab mafodotin, bortezomib, and dexamethasone; DVd, daratumumab, bortezomib, and dexamethasone; HR, hazard ratio; ITT, intention to treat; NR, not reached; OS, overall survival; R-ISS, Revised International Staging System. a Two patients in the ITT population were randomized, not treated, rescreened, and rerandomized. They are counted as 4 unique patients in this output. b CIs were estimated using the Brookmeyer-Crowley method. c HRs were estimated using a Cox proportional hazards model stratified by the number of lines of prior therapy (1 vs 2 or 3 vs ≥4), prior bortezomib (no vs yes), and R-ISS stage at screening (I vs II or III), with a covariate of treatment. d P value is from a 1-sided stratified log-rank test. At 171 actual events (48.2% OS information fraction), OS was declared significant if the P value was

  • DREAMM-7 trial shows sustained overall survival benefit for belantamab mafodotin combination versus daratumumab combination; benefit seen early and maintained through follow-up

  • Data build on findings from DREAMM-7 and DREAMM-8 and support the potential for belantamab mafodotin combinations to become standard of care

  • Belantamab mafodotin combinations are under regulatory review in seven major markets

PHILADELPHIA, December 09, 2024--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma. These data were featured today in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

The OS findings from DREAMM-7 build on previous data from the DREAMM-71 and DREAMM-82 trials, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both belantamab mafodotin-based combinations versus standard of care comparators.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "The compelling overall survival data from the DREAMM-7 trial establish the potential of belantamab mafodotin in combination to significantly extend the lives of patients with multiple myeloma at or after first relapse. This represents an important advancement that could redefine the treatment of relapsed or refractory multiple myeloma."

With a median follow up of 39.4 months, the analysis presented today shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). Although the median overall survival (mOS) was not reached in either arm of the study, the projected mOS for BVd is 84 months compared to 51 months for DVd.3

The three-year OS rate was 74% in the belantamab mafodotin combination arm and 60% in the daratumumab combination arm. The survival benefit favoring BVd was seen as early as four months and was sustained over time as illustrated by the separation of the lines in the Kaplan-Meier curve shown above.

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Hematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said: "The totality of evidence from DREAMM-7 represents a potential paradigm shift for multiple myeloma patients who have experienced a relapse or become refractory to initial treatment. The OS results shown with the belantamab mafodotin combination in DREAMM-7 further cement the potential of this regimen to prolong the lives of patients with relapsed or refractory multiple myeloma compared to a standard of care daratumumab combination."

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