Sanofi's Approved Blood Cancer Drug Sarclisa Shows Improved Progression-Free Survival In Patients Eligible For Transplant
Sanofi's Approved Blood Cancer Drug Sarclisa Shows Improved Progression-Free Survival In Patients Eligible For Transplant
On Thursday, Sanofi SA (NASDAQ:SNY) reported new results from the GMMG-HD7 phase 3 study of Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients.
賽諾菲安萬特（NASDAQ:SNY）週四公佈了Sarclisa與來那度胺、硼替佐米和地塞米松（RVd）聯合用於移植適應症新診斷的多發性骨髓瘤（NDMM）患者的GMMG-HD7三期研究的新結果，與RVd誘導相比，Sarclisa加來那度胺隨機後換藥與來那度胺維持治療相比，顯著延長了無進展生存期（PFS），導致疾病進展或死亡的比率顯著降低，而維持治療方案無關。
The data show that Sarclisa, combined with RVd during induction therapy, significantly prolonged progression-free survival (PFS), resulting in a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction regardless of the maintenance regimen.
數據顯示，Sarclisa在誘導治療期間與RVd聯合使用，顯著延長了無進展生存期（PFS），導致疾病進展或死亡的比率顯著降低，與無論維持治療方案如何，與RVd誘導相比，具有統計學意義和臨床意義的差異。
In December 2021, Sanofi and GMMG shared the results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients.
2021年12月，賽諾菲和GMMG分享了第一部分的結果，該研究在移植適應症新診斷多發性骨髓瘤患者中，在誘導治療後和移植前達到MRD陰性的主要終點。
In May 2024, the FDA accepted for Priority Review the supplemental Biologics License Application for Sarclisa plus VRd combo for transplant-ineligible newly diagnosed multiple myeloma patients.
2024年5月，FDA接受了Sarclisa + VRd聯合用藥在移植不適應的新診斷多發性骨髓瘤患者中的增補生物製品許可申請優先審查。
The target action date for the FDA decision is September 27, 2024. A regulatory submission is also under review in the European Union.
FDA決定的目標行動日期爲2024年9月27日。歐盟也正在審查監管提交。
GMMG-HD7 is one of six phase 3 studies to report results for Sarclisa in multiple myeloma (MM), which includes four positive readouts of a Sarclisa-based quadruplet in the frontline setting.
GMMG-HD7是Sarclisa在多發性骨髓瘤（MM）中報告六個三期研究之一，其中包括一種基於Sarclisa的四聯療法的四個陽性結果。
In June, Sanofi shared data from the IMROZ phase 3 study of Sarclisa, which enrolled 446 patients with newly diagnosed, transplant-ineligible multiple myeloma.
6月，賽諾菲分享了Sarclisa的IMROZ三期研究數據，該研究招募了446名新診斷的、移植不適應的多發性骨髓瘤患者。
At the data cut-off of September 26, 2023, through the median follow-up of 59.7 months, the following were observed for Sarclisa-VRd compared to VRd.
截至2023年9月26日的數據截止日期，在中位隨訪時間爲59.7個月的情況下，相比於VRd，Sarclisa-VRd呈現了以下情況。
The data demonstrated that Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen) reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd.
數據表明，Sarclisa（異名爲isatuximab）與標準治療硼替佐米、來那度胺和地塞米松（VRd）聯合使用，隨後使用Sarclisa-Rd（IMROZ方案），與VRd隨後使用Rd相比，將疾病進展或死亡風險降低了40%。
Price Action: SNY stock is up 0.52% at $52.07 at last check Thursday.
截至週四最後檢查時，SNY股票上漲0.52％，至52.07美元。
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Image by HJBC via Shutterstock
圖像來自Shutterstock用戶HJBC。