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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肿瘤学公司的Rubra在前列腺癌设置中实现了主要目标
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.
  • 克洛维斯肿瘤公司纳斯达克公司(Temasek Holdings：CLVS)宣布了TRITON3期试验的TOPLINE数据，显示与对照组相比，Rubra单一疗法显著提高了放射学无进展生存率(RPFS)。
  • 对照组由医生选择多西紫杉醇、醋酸阿比特龙或苯扎鲁胺组成。
  • 在TRITON3研究中观察到的Rubra的安全性与Rubra的标签一致。
  • 相关： FDA在Clovis提交Rubra治疗卵巢癌申请之前的建议.
  • 在2023年第一季度，该公司计划向FDA提交BRCA亚组患者的补充营销申请。它打算与FDA讨论提交给更广泛的ITT人群。
  • 对于rPFS的主要终点，Rubra组比对照组有统计学意义，危险比为0.50。接受Rubra治疗的BRCA突变患者的中位PFS为11.2个月，而接受医生选择的患者的中位PFS为6.4个月。
  • 参加TRITON3并接受Rubra治疗的所有患者的中位PFS分别为10.2个月和6.4个月。
  • 在尚未成熟的BRCA亚组和ITT人群中，对总体生存期(OS)的次要终点进行中期分析的风险比更倾向于Rubra。在成熟的ATM探索性亚组中，OS的危险比偏向于对照组。
  • 价格行动：CLVS股价周一收盘上涨0.50%，至1.20美元。
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