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On Sunday, GSK plc (NYSE:GSK) released results from an interim analysis of the DREAMM-8 phase 3 head-to-head trial evaluating Blenrep (belantamab mafodotin) in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex for relapsed or refractory multiple myeloma.
The data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
On the primary endpoint of progression-free survival (PFS), the belantamab mafodotin combination (n=155) showed a statistically significant and clinically meaningful improvement compared to the bortezomib combination (n=147).
The median PFS was not yet reached with the belantamab mafodotin combination at a median follow-up of 21.8 months, compared to 12.7 months in the bortezomib combination.
At the end of one year, 71% of patients in the belantamab mafodotin combination group compared to 51% in the bortezomib combination group were alive and had not progressed.
A benefit for belantamab mafodotin plus PomDex was observed across all pre-specified subgroups, including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.
A positive overall survival (OS) trend was observed but not statistically significant at the interim analysis.
OS follow-up continues and further analyses are planned. At the end of one year, 83% of patients were alive in the belantamab mafodotin combination group versus 76% in the bortezomib combination group.
The safety and tolerability profile of the belantamab mafodotin combination was broadly consistent with the known profile of the individual agents.
Findings from the DREAMM-7 Phase 3 head-to-head trial evaluating belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex in the same treatment setting were presented at the American Society of Clinical Oncology Plenary Series in February 2024.
In November 2022, GSK initiated the withdrawal process of the U.S. marketing authorization for Blenrep after a failed DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
The European Medicines Agency's human medicines committee recommended not renewing the conditional marketing authorization for Blenrep (belantamab mafodotin) for multiple myeloma.
Price Action: GSK shares were down 8.74% to $40.86 at the last check on Monday.
Photo via Wikimedia Commons
Posted In: GSK
