Roche's Lymphoma Drug With Chemo Extends Survival In Pretreated Patients
Roche's Lymphoma Drug With Chemo Extends Survival In Pretreated Patients
Monday, Roche Holdings AG (OTC:RHHBY) announced topline data from Phase 3 STARGLO study of Columvi (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in certain subset of patients with diffuse large B-cell lymphoma.
週一，羅氏控股股份公司（場外交易代碼：RHHBY）公佈了對Columvi（glofitamab）聯合吉西他濱加奧沙利鉑（GemoX）對比Mabthera/Rituxan（利妥昔單抗）聯合GemoX的3期STARGLO研究的主要數據，該研究對某些瀰漫性大B細胞淋巴瘤患者進行了研究。
The Phase 3 STARGLO study met its primary endpoint of overall survival.
STARGLO的3期研究達到了其主要終點，即總存活率。
The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx.
該研究表明，復發或難治性（R/R）瀰漫性大B細胞淋巴瘤（DLBCL）患者，先前接受過至少一線治療且不適合自體幹細胞移植，與mabthera/Rituxan（利妥昔單抗）聯合使用Columvi（glofitamab）與吉西他濱和奧沙利鉑（GemoX）相比，使用Columvi（glofitamab）聯合使用吉西他濱和奧沙利鉑（GemoX）的壽命更長) 與 GemoX 結合使用。
The safety of the combination appeared consistent with the known safety profiles of the individual medicines.
該組合的安全性似乎與個別藥物的已知安全特徵一致。
Columvi was the first fixed-duration bispecific antibody to receive FDA accelerated approval and conditional marketing authorization from the European Commission to treat people with R/R DLBCL after two or more lines of systemic therapy.
Columvi是第一個獲得美國食品藥品管理局加速批准和歐盟委員會有條件上市許可的固定療程雙特異性抗體，用於治療經過兩條或更多系列全身療法後的復發/難治性DLBCL患者。
Approvals were based on the results of Columvi as a monotherapy from the pivotal Phase 1/2 NP30179 study in patients with R/R DLBCL who had previously received two or more prior treatments.
批准以Columvi作爲單一療法的結果爲基礎，該研究是針對先前接受過兩次或更多治療的複發性/難治性DLBCL患者進行的 NP30179 關鍵研究的結果。
Earlier this year, Roche terminated two cancer drug deals.
今年早些時候，羅氏終止了兩項抗癌藥物交易。
- In February, Repare Therapeutics Inc (NASDAQ:RPTX) regained global development and commercialization rights to camonsertib (RP-3500) following the termination of its collaboration agreement with Roche.
- In January, Roche decided to terminate the collaboration and licensing agreement for HOOKIPA Pharma Inc's (NASDAQ:HOOK) HB-700 program in KRAS mutated cancers. Effective April 25, 2024, HOOKIPA will regain full control.
- 2月，Repare Therapeutics Inc（納斯達克股票代碼：RPTX）在與羅氏的合作協議終止後重新獲得了camonsertib（RP-3500）的全球開發和商業化權。
- 1月，羅氏決定終止HOOKIPA Pharma Inc（納斯達克股票代碼：HOOK）針對KRAS突變癌症的 HB-700 計劃的合作和許可協議。自2024年4月25日起，HOOKIPA將重新獲得完全控制權。
Price Action: RHHBY shares closed at $30.59 on Friday.
價格走勢：RHBY股價週五收於30.59美元。