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Clovis Oncology to Highlight Rubraca (rucaparib) Data from Post-Hoc ARIEL3 Analyses at SGO 2019 Congress

Nachrichtenquelle: Business Wire (engl.)
16.03.2019, 17:45  |  670   |   |   

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that data from post hoc exploratory analyses from the ARIEL3 Phase 3 clinical study of Rubraca will be presented during oral plenary and poster sessions at the Society of Gynecologic Oncology 2019 Congress (SGO), March 16 -19, 2019 in Honolulu, Hawaii. Data to be presented will highlight ARIEL3 results in different patient demographics, including age and deleterious germline mutation status.

“The results from these post hoc analyses of the ARIEL3 study data underscore the safety and efficacy of Rubraca across a broad range of women with recurrent ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We hope that our continuing exploration, analysis and publication of ARIEL3 data will help inform treatment decisions as well as the management of advanced ovarian cancer.”

Included in the SGO 2019 Congress Scientific Plenary 1 session is the following:

Title: The effect of age on efficacy and safety outcomes with rucaparib: a post hoc exploratory analysis of ARIEL3, a phase 3, randomized, placebo-controlled maintenance study in patients with recurrent ovarian carcinoma

Presenter: Jonathan A. Ledermann

Session: Scientific Plenary I: Snap, Crackle, PARP

Date/Time: March 16, 2019; 6:45 – 7:45am (HST) // 12:45 – 11:45pm (EDT)

Location: Kamehameha 3

Summary: The efficacy and safety of Rubraca maintenance treatment was investigated in three age-based sub-groups from ARIEL3 in a post-hoc exploratory analysis. In the intent-to-treat (ITT) population, investigator-assessed median PFS for patients aged <65 years was 11.1 months (n=237) in the Rubraca arm vs 5.4 months (n=117) in the placebo arm (hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.25–0.43); for patients aged 65–74 years, median PFS was 8.3 months (n=113) vs 5.3 months (n=64) (HR, 0.43; 95% CI, 0.29–0.64); and for patients aged ≥75 years, median PFS was 9.2 months (n=25) vs 5.5 months (n=8) (HR, 0.47; 95% CI, 0.16–1.35).

In this dataset, maintenance treatment with Rubraca improved median PFS and reduced the risk of progression vs placebo regardless of age subgroup. In general, the safety profile of Rubraca was consistent across the three age subgroups.

“As we continue to explore and expand our use of PARP inhibitors for the maintenance treatment of recurrent ovarian cancer, it’s helpful for physicians to know how individual factors such as patient age may impact treatment decisions,” said Professor Jonathan Ledermann, MD, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, Global Principal Investigator for non-US sites in the ARIEL3 study. “In our analysis of the ARIEL3 study, we found that maintenance treatment with Rubraca improved median PFS, reduced the risk of progression and had a consistent safety profile regardless of age, suggesting that patient age should not discourage physicians from considering Rubraca in this setting.”

Included in an SGO 2019 Congress poster presentation session is the following:

Title: Post hoc exploratory analysis of rucaparib in patients with platinum-sensitive recurrent ovarian carcinoma from the randomized, placebo-controlled phase 3 study ARIEL3: effect of a deleterious germline or no germline BRCA mutation on efficacy and safety

Presenter: Robert L. Coleman

Date/Time: March 18, 2019; 6:00 – 10:00am and 3:30 – 5:00pm (HST)// 12:00 – 4:00pm and 9:30 –11pm (EDT)

Location: Kamehameha 2

Summary: For this analysis, researchers assessed PFS in the subgroup of patients with a deleterious germline BRCA mutation (germline BRCA mutation) and in patients without a deleterious germline BRCA mutation (no germline BRCA mutation). In these subgroups, Rubraca significantly improved PFS vs placebo regardless of BRCA mutation status. Although the reduction in risk was numerically greater in the germline BRCA mutation subgroup (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.16–0.39) than in the no germline BRCA mutation subgroup (HR, 0.41; 95% CI, 0.32–0.52), the reduction in risk between the two subgroups did not differ by a statistically significant margin. The safety profile of Rubraca vs placebo in the germline BRCA mutation and no germline BRCA mutation subgroups was consistent with the safety profile of Rubraca in the overall safety population reported previously.

This post hoc exploratory analysis demonstrated that the reduction in risk was numerically greater in the germline BRCA mutation subgroup than in the no germline BRCA mutation subgroup. In the no germline BRCA mutation subgroup, the observed improvement in PFS was not driven solely by the somatic BRCA mutation + wild-type BRCA/high LOH subgroup as demonstrated by the analysis of patients with wild-type BRCA tumors.

“While it is evident that women whose tumors possess a BRCA mutation derive the greatest benefit from rucaparib therapy, the data presented in this poster demonstrate the meaningful and clinically relevant benefit that eligible patients, including those without a BRCA mutation, may receive as a result of maintenance treatment,” said Robert L. Coleman, MD, Professor, Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston and co-Coordinating Investigator in the ARIEL3 clinical trial program. “These data further reinforce the importance of maintenance treatment for women with recurrent ovarian cancer versus the previous standard of observation following treatment with chemotherapy.”

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