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6-K: Lenrep Shows Overall Survival Benefit in Head-to-Head Dreamm-7 Phase Iii Trial for Relapsed/Refractory Multiple Myeloma

6-K: Lenrep Shows Overall Survival Benefit in Head-to-Head Dreamm-7 Phase Iii Trial for Relapsed/Refractory Multiple Myeloma

6-K:Lenrep在针对复发/难治性多发性骨髓瘤的Dreamm-7III期头对头试验中显示出总体生存获益
美股SEC公告 ·  2024/11/14 04:46

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GSK announced positive results from the DREAMM-7 phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma. The trial met its key secondary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of death when Blenrep was combined with bortezomib and dexamethasone (BorDex) compared to daratumumab plus BorDex.Full data will be presented at the American Society of Hematology Annual Meeting on December 9, 2024. GSK plans to share these results with health authorities to support regulatory filings. Blenrep combinations have already been filed for approval in several countries based on DREAMM-7 and DREAMM-8 trial results.The DREAMM-7 trial involved 494 patients with relapsed/refractory multiple myeloma who had received at least one prior line of therapy. The positive overall survival results highlight Blenrep's potential to extend patients' lives and potentially transform treatment in this setting. GSK continues to evaluate Blenrep in earlier treatment lines and in combination with other therapies through its DREAMM clinical development program.
GSK announced positive results from the DREAMM-7 phase III trial for Blenrep (belantamab mafodotin) in relapsed/refractory multiple myeloma. The trial met its key secondary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of death when Blenrep was combined with bortezomib and dexamethasone (BorDex) compared to daratumumab plus BorDex.Full data will be presented at the American Society of Hematology Annual Meeting on December 9, 2024. GSK plans to share these results with health authorities to support regulatory filings. Blenrep combinations have already been filed for approval in several countries based on DREAMM-7 and DREAMM-8 trial results.The DREAMM-7 trial involved 494 patients with relapsed/refractory multiple myeloma who had received at least one prior line of therapy. The positive overall survival results highlight Blenrep's potential to extend patients' lives and potentially transform treatment in this setting. GSK continues to evaluate Blenrep in earlier treatment lines and in combination with other therapies through its DREAMM clinical development program.
GSk宣布了DREAMm-7三期试验中Blenrep(belantamab mafodotin)在复发/难治性多发性骨髓瘤中的积极结果。该试验达到了关键的次要终点,显示出与达拉图单抗加BorDex相比,Blenrep与博来霉素和地塞米松(BorDex)联合使用时在死亡风险方面具有统计学显著性和临床意义的降低。完整数据将在2024年12月9日美国血液学会年会上发布。GSk计划与卫生机构分享这些结果,以支持监管申报。基于DREAMm-7和DREAMm-8试验结果,Blenrep的联合用药已在多个国家申请批准。DREAMm-7试验涉及494名复发/难治性多发性骨髓瘤患者,他们至少接受过一项先前的治疗方案。积极的总体生存结果突显了Blenrep延长患者生命的潜力,并可能改变该领域的治疗。GSk继续通过其DREAMm临床开发计划评估Blenrep在更早治疗方案中的应用及与其他疗法的联合使用。
GSk宣布了DREAMm-7三期试验中Blenrep(belantamab mafodotin)在复发/难治性多发性骨髓瘤中的积极结果。该试验达到了关键的次要终点,显示出与达拉图单抗加BorDex相比,Blenrep与博来霉素和地塞米松(BorDex)联合使用时在死亡风险方面具有统计学显著性和临床意义的降低。完整数据将在2024年12月9日美国血液学会年会上发布。GSk计划与卫生机构分享这些结果,以支持监管申报。基于DREAMm-7和DREAMm-8试验结果,Blenrep的联合用药已在多个国家申请批准。DREAMm-7试验涉及494名复发/难治性多发性骨髓瘤患者,他们至少接受过一项先前的治疗方案。积极的总体生存结果突显了Blenrep延长患者生命的潜力,并可能改变该领域的治疗。GSk继续通过其DREAMm临床开发计划评估Blenrep在更早治疗方案中的应用及与其他疗法的联合使用。
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