ARIEL3 Efficacy

Rubraca significantly extended PFS and demonstrated
anti-tumor efficacy for patients with BRCA 1/2 mutations1,2

BRCAmut+ PFS
BRCAmut+ ORR

In the BRCAmut+ population, Rubraca demonstrated a statistically significant median PFS benefit of 16.6 months vs 5.4 months with placebo in 2La maintenance1,2

  • Rubraca more than tripled (3.1x) median PFS compared to placebo in the BRCAmut+ population1
  • IRR-assessed PFS (secondary endpoint, N=196):
    • Rubraca demonstrated a statistically significant median PFS benefit of 26.8 months vs 5.4 months with placebo (HR=0.20 (95% CI, 0.13 - 0.32)2
    • No multiplicity adjustment method for IRR PFS was specified in study protocol. At the time of PFS analysis, overall survival data were not mature (22% of events had occurred).1

BRCAmut+

Primary endpoint: Investigator-assessed PFS (N=196)b

Line chart of Rubraca trial results In the BRCAmut+ population

Figure references.1-3,5,6

In the BRCAmut+ population, Rubraca further reduced the tumor burden in 2La maintenance treatment among those with residual diseaseb-d,4

  • Rubraca demonstrated over 4 times (4.5x) higher ORR vs placebo in the BRCAmut+ populationb-d
  • 65% of all patients in ARIEL3 had residual disease
  • This analysis is exploratory in nature and does not control for Type 1 error rate.

BRCAmut+

Confirmed response rate

Bar chart of overall response rate (ORR) by BRCAmut+ in Rubraca patients
BRCAmut+ PFS

In the BRCAmut+ population, Rubraca demonstrated a statistically significant median PFS benefit of 16.6 months vs 5.4 months with placebo in 2La maintenance1,2

  • Rubraca more than tripled (3.1x) median PFS compared to placebo in the BRCAmut+ population1
  • IRR-assessed PFS (secondary endpoint, N=196):
    • Rubraca demonstrated a statistically significant median PFS benefit of 26.8 months vs 5.4 months with placebo (HR=0.20 (95% CI, 0.13 - 0.32)2
    • No multiplicity adjustment method for IRR PFS was specified in study protocol. At the time of PFS analysis, overall survival data were not mature (22% of events had occurred).1

BRCAmut+

Primary endpoint: Investigator-assessed PFS (N=196)b

Line chart of Rubraca trial results In the BRCAmut+ population

Figure references.1-3,5,6

BRCAmut+ ORR

In the BRCAmut+ population, Rubraca further reduced the tumor burden in 2La maintenance treatment among those with residual diseaseb-d,4

  • Rubraca demonstrated over 4 times (4.5x) higher ORR vs placebo in the BRCAmut+ populationb-d
  • 65% of all patients in ARIEL3 had residual disease
  • This analysis is exploratory in nature and does not control for Type 1 error rate.

BRCAmut+

Confirmed response rate

Bar chart of overall response rate (ORR) by BRCAmut+ in Rubraca patients

Safety & Tolerability

The majority of adverse reactions and lab abnormalities were Grades 1 or 21

SEE SAFETY PROFILE
  • aRubraca was studied in patients who had received at least 2 lines of chemotherapy.
  • bEvaluated according to RECIST v1.1.1,3,6
  • cNo disease=all patients who had no target lesions or non-target lesions at baseline.6
  • dPooled measurable and non-measurable disease at baseline.4
  • eTen patients could not be definitively assessed as germline or somatic (n=8 with Rubraca and n=2 with placebo).6
  • fTumor sample was not evaluable for percentage of genomic LOH due to low tumor content or aneuploidy.
  • gPrevious treatment with bevacizumab was permitted as part of penultimate or earlier treatment.
  • 2L, second-line; BRCA, breast cancer susceptibility gene; BRCAmut+, BRCA-mutation positive, which includes mutations in the BRCA1 and/or BRCA2 gene; BRCAwt, BRCA wild-type; CA125, cancer antigen 125; CI, confidence interval; CR, complete response; GCIG, Gynecologic Cancer InterGroup; HR, hazard ratio; HRd, homologous recombination-deficient; HRp, homologous recombination-proficient (HRd-); IRR, independent radiological review; LOH, loss of heterozygosity; ORR, objective response rate; PFS, progression-free survival; PR, partial response; RECIST v1.1, Response Evaluation Criteria in Solid Tumors. Version 1.1; rOC, recurrent ovarian cancer.

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