Express Doubled Progression-Free Survival, PARP Inhibitor First-Line Maintenance Therapy for Ovarian Cancer Phase 3 Clinical Results Positive

▎WuXi AppTec Content Team Editors Today, Clovis Oncology announced that its PARP inhibitor Rubraca (rucaparib) has achieved positive results in a Phase 3 clinical trial as a first-line maintenance therapy
.

Significantly improved investigator-assessed progression-free survival (PFS) compared to placebo
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Notably, the improvement in PFS was independent of the patient's biomarker profile
.

Ovarian cancer is the eighth leading cause of cancer death in women worldwide
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In 2020, GLOBOCAN estimates that more than 300,000 women were diagnosed and more than 200,000 patients died
.

Although the majority of patients with advanced ovarian cancer respond to initial treatment, approximately 80% of patients with advanced ovarian cancer will relapse and require subsequent treatment
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Advanced ovarian cancer can be divided into different types based on genetic biomarkers, including homologous recombination repair deficiency (HRD)-positive and HRD-negative, and HRD-positive patients can be divided into two subtypes with BRCA gene mutations and those without BRCA gene mutations.
group
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Rubraca is an oral small molecule PARP1, 2, 3 inhibitor
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PARP plays an important role in DNA damage repair, and by targeting PARP, Rubraca can cause HRD-positive tumor cells to die due to accumulation of excessive DNA damage
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In this randomized, double-blind, placebo-controlled Phase 3 clinical trial, patients with newly diagnosed ovarian cancer received Rubraca monotherapy or placebo after receiving first-line chemotherapy and achieving remission
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Trial results showed: Across all randomized patient populations, median PFS was 20.
2 months in the Rubraca group and 9.
2 months in the control group (p<0.
0001)
.

In the HRD-positive subgroup of patients, Rubraca reduced the risk of disease progression or death by 53% (HR=0.
47, 95% CI: 0.
31-0.
72)
.

Median PFS was 28.
7 months in the Rubraca group and 11.
3 months in the control group (p=0.
0004)
.

An exploratory endpoint was also assessed in a subgroup of HRD-negative patients, in which Rubraca reduced the risk of disease progression or death by 35% (HR=0.
65, 95% CI: 0.
45-0.
95)
.

Median PFS was 12.
1 months in the Rubraca group and 9.
1 months in the placebo group (p=0.
0284)
.

"The results of this study of Rubraca as a first-line maintenance treatment for ovarian cancer exceeded our expectations, with significant improvements in PFS across all patient populations assessed for the primary efficacy endpoint
,
" said Mr.
Patrick J.
Mahaffy, President and Chief Executive Officer of Clovis Oncology, "We believe that These positive results show that Rubraca provides a new option for first-line maintenance therapy for patients with advanced ovarian cancer
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We look forward to filing with regulatory agencies in the US and EU in the second and third quarters of this year
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"Reference: [1] Clovis Oncology's Rubraca® (Rucaparib) Significantly Improves Progression-Free Survival in First-line Maintenance Treatment in Women with Ovarian Cancer Regardless of Their Biomarker Status in Phase 3 ATHENA-MONO Trial.
Retrieved March 31, 2022, from https:// -line-Maintenance-Treatment-in-Women-with-Ovarian-Cancer-Regardless-of-Their-Biomarker-Status-in-Phase-3-ATHENA-MONO-Trial The progress of medical and health research
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