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Merck Reveals Mixed Data From Keytruda/Lynparza Regime In Ovarian Cancer

Merck Reveals Mixed Data From Keytruda/Lynparza Regime In Ovarian Cancer

默沙東公佈了在卵巢癌治療中Keytruda/Lynparza方案的混合數據
Benzinga ·  2024/12/09 15:50

On Monday, Merck & Co Inc (NYSE:MRK) announced topline data from the Phase 3 KEYLYNK-001 trial.

在週一,默沙東公司(紐交所:MRK)公佈了三期KEYLYNk-001試驗的初步數據。

The trial evaluating Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza (olaparib), with or without bevacizumab, as a first-line treatment for BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival.

該試驗評估了Keytruda(佩姆布羅利單抗)加化療,然後以Lynparza(奧拉帕利)進行維持治療,是否可用於第一線治療BRCA非突變晚期上皮性卵巢癌,達到了無進展生存期的主要終點。

Also Read: Merck's Multi-Billion Dollar Drug Keytruda's Investigational Under The Skin Injection At Par With Intravenous Formulation In Untreated Lung Cancer Patients

另請閱讀:默沙東的數十億美元藥物Keytruda在未治療的肺癌患者中進行的皮下注射的研究結果與靜脈注射製劑相媲美。

At the final analysis conducted by an independent Data Monitoring Committee, the Keytruda plus Lynparza regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for these patients compared to chemotherapy alone.

在獨立數據監測委員會進行的最終分析中,Keytruda加Lynparza的方案在無進展生存期方面顯示出統計學顯著性和臨床意義上的改善,與單獨化療相比,對這些患者效果顯著。

The study did not reach its secondary endpoint of overall survival. The role of keytruda in the intention-to-treat population remains uncertain at this time.

該研究未達到其整體生存期的次要終點。Keytruda在意向性治療人群中的作用目前仍不確定。

In the U.S., Lynparza has three approved indications in ovarian cancer. Keytruda is not approved to treat ovarian cancer.

在美國,Lynparza已獲得三項針對卵巢癌的批准適應症。Keytruda並未獲批用於治療卵巢癌。

Sunday, Merck announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone plus rituximab (R-CHP) for previously untreated diffuse large B-cell lymphoma (DLBCL).

週日,默沙東宣佈了關於二期waveLINE-007試驗的數據首次發佈,該試驗評估了zilovertamab vedotin與環磷酰胺、多柔比星和潑尼松聯合利妥昔單抗(R-CHP)用於先前未治療的瀰漫性大B細胞淋巴瘤(DLBCL)的效果。

At a pre-planned analysis, zilovertamab vedotin in combination with R-CHP achieved a 100% (n=15) complete response (CR) rate in patients treated with zilovertamab vedotin at 1.75 mg/kg.

在一項預先計劃的分析中,zilovertamab vedotin與R-CHP聯合治療在接受zilovertamab vedotin 1.75 mg/kg治療的患者中達到了100%的完全緩解率(n=15)。

Based on the data, the study has established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin.

根據數據,研究已確定1.75 mg/kg爲推薦的三期藥物zilovertamab vedotin劑量。

The efficacy results showed a complete response was achieved in combination with R-CHP in 100% (n=15) of patients receiving the 1.75 mg/kg dose of zilovertamab vedotin, 93.3% (n=14) of patients receiving the 2.0 mg/kg dose, and 100% (n=6) of patients receiving the 2.25 mg/kg dose.

療效結果顯示,接受1.75 mg/kg zilovertamab vedotin劑量的患者中,100%(n=15)的患者在與R-CHP聯合使用時取得了完全緩解,接受2.0 mg/kg劑量的患者中達到93.3%(n=14),接受2.25 mg/kg劑量的患者中達到100%(n=6)。

The total complete response rate at the end of treatment was 97.2%. The median follow-up for all patients was 17.6 months.

治療結束時的完全緩解率爲97.2%。所有患者的中位隨訪期爲17.6個月。

The objective response rate was 100% for patients receiving the 1.75 mg/kg dose, 93.3% for patients receiving the 2.0 mg/kg dose, and 100% for patients receiving the 2.25 mg/kg dose, all combined with R-CHP.

接受1.75 mg/kg劑量的患者的客觀反應率爲100%,接受2.0 mg/kg劑量的患者爲93.3%,接受2.25 mg/kg劑量的患者爲100%,所有患者均與R-CHP聯合使用。

The median duration of response has not been reached for all patients, and the total 12-month duration of response was 93.5%.

所有患者的反應中位持續時間尚未達到,反應的總12個月持續時間爲93.5%。

Based on the data, the recommended zilovertamab vedotin dose was determined to be 1.75 mg/kg.

根據數據,推薦的zilovertamab vedotin劑量被確定爲1.75 mg/kg。

Price Action: MRK stock is up 0.99% at $104.11 at last check Monday.

價格動態:默沙東股票週一最後交易時上漲0.99%,達到104.11美元。

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Photo via Shutterstock.

圖片來自shutterstock。

譯文內容由第三人軟體翻譯。


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