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Clovis Oncology's Rubraca Hits Primary Goal In Prostate Cancer Settings

Clovis Oncology's Rubraca Hits Primary Goal In Prostate Cancer Settings

Clovis腫瘤學公司的Rubra在前列腺癌設置中實現了主要目標
Benzinga Real-time News ·  2022/10/03 13:36
  • Clovis Oncology Inc (NASDAQ:CLVS) announced topline data from the Phase 3 TRITON3 trial, demonstrating that Rubraca monotherapy treatment significantly improved radiographic progression-free survival (rPFS) compared with the control group.
  • The control group consisted of the physician's choice of docetaxel, abiraterone acetate, or enzalutamide.
  • The safety profile of Rubraca observed in the TRITON3 study was consistent with Rubraca labeling.
  • Related: FDA's Recommendation Before Clovis Submits Rubraca Application For Ovarian Cancer.
  • During the first quarter of 2023, the company plans to submit a supplemental marketing application to the FDA for the BRCA subgroup of patients. It intends to discuss with the FDA submitting for the broader ITT population.
  • The Rubraca arm achieved statistical significance over the control arm for the primary endpoint of rPFS with a hazard ratio of 0.50. The median PFS for the population of patients with BRCA mutations treated with Rubraca was 11.2 months vs. 6.4 months among those who received a physician's choice.
  • The median PFS for all patients enrolled in TRITON3 and treated with Rubraca was 10.2 months vs. 6.4 months.
  • The hazard ratio for the interim analysis of the secondary endpoint of overall survival (OS) in the BRCA subgroup and ITT population, which are not yet mature, favored Rubraca. The hazard ratio for OS in the exploratory subgroup of ATM, which is mature, favored the control arm.
  • Price Action: CLVS shares are up 0.50% at $1.20 on the last check Monday.
  • 克洛維斯腫瘤公司納斯達克公司(Temasek Holdings：CLVS)宣佈了TRITON3期試驗的TOPLINE數據，顯示與對照組相比，Rubra單一療法顯著提高了放射學無進展生存率(RPFS)。
  • 對照組由醫生選擇多西紫杉醇、醋酸阿比特龍或苯扎魯胺組成。
  • 在TRITON3研究中觀察到的Rubra的安全性與Rubra的標籤一致。
  • 相關： FDA在Clovis提交Rubra治療卵巢癌申請之前的建議.
  • 在2023年第一季度，該公司計劃向FDA提交BRCA亞組患者的補充營銷申請。它打算與FDA討論提交給更廣泛的ITT人羣。
  • 對於rPFS的主要終點，Rubra組比對照組有統計學意義，危險比為0.50。接受Rubra治療的BRCA突變患者的中位PFS為11.2個月，而接受醫生選擇的患者的中位PFS為6.4個月。
  • 參加TRITON3並接受Rubra治療的所有患者的中位PFS分別為10.2個月和6.4個月。
  • 在尚未成熟的BRCA亞組和ITT人羣中，對總體生存期(OS)的次要終點進行中期分析的風險比更傾向於Rubra。在成熟的ATM探索性亞組中，OS的危險比偏向於對照組。
  • 價格行動：CLVS股價週一收盤上漲0.50%，至1.20美元。
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