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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在針對復發/難治性多發性骨髓瘤的Dreamm-7III期頭對頭試驗中顯示出總體生存獲益
美股SEC公告 ·  2024/11/14 19:46

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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宣佈了DREAMm-7三期試驗中Blenrep（belantamab mafodotin）在復發/難治性多發性骨髓瘤中的積極結果。該試驗達到了關鍵的次要終點，顯示出與達拉圖單抗加BorDex相比，Blenrep與博來黴素和地塞米松（BorDex）聯合使用時在死亡風險方面具有統計學顯著性和臨牀意義的降低。完整數據將在2024年12月9日美國血液學會年會上發佈。GSk計劃與衛生機構分享這些結果，以支持監管申報。基於DREAMm-7和DREAMm-8試驗結果，Blenrep的聯合用藥已在多個國家申請批准。DREAMm-7試驗涉及494名復發/難治性多發性骨髓瘤患者，他們至少接受過一項先前的治療方案。積極的總體生存結果突顯了Blenrep延長患者生命的潛力，並可能改變該領域的治療。GSk繼續通過其DREAMm臨牀開發計劃評估Blenrep在更早治療方案中的應用及與其他療法的聯合使用。
GSk宣佈了DREAMm-7三期試驗中Blenrep（belantamab mafodotin）在復發/難治性多發性骨髓瘤中的積極結果。該試驗達到了關鍵的次要終點，顯示出與達拉圖單抗加BorDex相比，Blenrep與博來黴素和地塞米松（BorDex）聯合使用時在死亡風險方面具有統計學顯著性和臨牀意義的降低。完整數據將在2024年12月9日美國血液學會年會上發佈。GSk計劃與衛生機構分享這些結果，以支持監管申報。基於DREAMm-7和DREAMm-8試驗結果，Blenrep的聯合用藥已在多個國家申請批准。DREAMm-7試驗涉及494名復發/難治性多發性骨髓瘤患者，他們至少接受過一項先前的治療方案。積極的總體生存結果突顯了Blenrep延長患者生命的潛力，並可能改變該領域的治療。GSk繼續通過其DREAMm臨牀開發計劃評估Blenrep在更早治療方案中的應用及與其他療法的聯合使用。
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