ARIEL3 Trial Design

ARIEL3 is the Largest Pivotal Phase 3 Trial of a PARP Inhibitor as Maintenance Treatment for Recurrent Ovarian Cancer1-4

Continue until disease progression or unacceptable toxicity1

Randomized patients evaluated per a step-down analysis of 3 nested cohorts.b,1,2

More BRCAwt patients were enrolled in ARIEL3 than any other registrational trial for an approved PARP inhibitor in the maintenance setting1-4

Flow chart of Rubraca trial design results in patients enrolled and randomizedFlow chart of Rubraca trial design results in patients enrolled and randomized

ARIEL3 Enrolled a Broad, Clinically Relevant Patient Population Including Those with a Poor Prognosis and Difficult-to-Treat Disease, Regardless of Biomarker Status

Study patients reflected a clinically relevant population1,2

Disease characteristicsc

Pie chart of BRCA wild-type disease characteristics in Rubraca patients

with residual disease

  • 37% had measurable disease (18% with bulky disease)
  • 28% had non-measurable disease (investigator-assessed)
Pie chart of BRCA wild-type disease characteristics in Rubraca patients

were BRCAwt

  • 28% (n=158) were BRCAwt, HRd
  • 29% (n=161) were BRCAwt, HRp
  • 8% (n=49) were LOH indeterminant

Treatment history

  • 66% had a PR and 34% had a CR to the last platinum-based chemotherapy
  • 64% of patients who received 2 prior lines of chemotherapy achieved a PR
  • 22% of patients had received prior bevacizumab

Patient characteristics

  • Median age for patients was 61 years (range 36-85)
  • 74% had a 0 and 26% had a 1 ECOG performance status
  • 80% of patients were white
  • Baseline characteristics were well balanced between treatment arms

ARIEL3 Efficacy

Rubraca significantly extended PFS and demonstrated anti-tumor efficacy1,2,5

SEE THE DATA
  • aEvaluated according to RECIST v1.1.
  • b1) BRCAmut+ patients, 2) HRd patients, and 3) all randomized patients.
  • cPooled for all randomized patients (N=564)
  • BID, twice a day; BRCA, breast cancer susceptibility gene; BRCAmut+, BRCA-mutation positive, which includes mutations in the BRCA1 and/or BRCA2 gene; BRCAwt, BRCA wild-type; CR, complete response; ECOG, Eastern Cooperative Oncology Group; HR, homologous recombination; HRd, HR-deficient; HRp, HR-proficient (HRd-); LOH, loss of heterozygosity; PARP, poly (ADP-ribose) polymerase; PFS, progression-free survival; PR, partial response.

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