TRITON2 Data

Rubraca Demonstrated
Anti-Tumor Efficacy1

44% of patients achieved a
response with Rubraca

  • ORR was defined per modified RECIST v1.1 criteria and with no confirmed bone progression per PCWG31
  • The ORR by IRR was similar in patients with germline vs somatic BRCA mutation1
  • Rapid response with Rubraca: of those that responded, the majority (70%) achieved an initial response by the first follow-up scan (week 8 visit)2
  • Six (9.7%) patients treated with Rubraca had disease progression2
  • One (1.6%) patient was not evaluable2

Primary endpoint:
IRR-assessed confirmed
Objective Response Rate (ORR) (N=62)a,1

Rubraca Demonstrated Durability1

Of the patients with a confirmed ORR, 56% of patients responded >6 months with the longest response ongoing at 2 years1,2

  • The majority of patients (56%; 15/27) with a confirmed objective response had a DOR of ≥6 months1
  • Treatment with Rubraca was still ongoing in 44% (12/27) of patients at the time of data cut-off2
  • Median follow-up of 17.3 months3

Secondary endpoint:
IRR-assessed Duration
of Response (DOR)a

Change in Prostate-Specific Antigen (PSA) Levels
From Baseline in TRITON2

Secondary endpoint:
Change in PSA levels from baseline (N=115)b

Changes in PSA levels may be observed but have not been shown to correlate with clinical
benefit or progression in individual patients treated with Rubraca

Rubraca is the First FDA-Approved
PARP Inhibitor in mCRPCc,1

TRITON2 includes the largest population of BRCAmut+ mCRPC patients
evaluated on an approved single-agent PARP inhibitor

Continue until disease progression or unacceptable toxicity.1

All patients received a concomitant GnRH analog or had prior bilateral orchiectomy.1

Efficacy was Evaluated in Patients With Advanced
Age and Extensive Disease Burden (N=62)1,3

TRITON2 included a demographically diverse mCRPC patient population

Disease characteristics

Genetic characteristics

Treatment history

Safety & Tolerability

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

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  • aORR and DOR were assessed by blinded IRR and the investigator according to modified RECIST version 1.1/PCWG3 criteria.
  • bFor a PSA50 and PSA90 response, respectively, the proportion of patients with a ≥50% decrease or a ≥90% decrease from baseline confirmed by a second consecutive measurement at least 3 weeks later; PSA measurements performed by local laboratory.
  • cFDA approval is contingent upon verification and description of clinical benefit in confirmatory trials.
  • dIncluded patients with BRCA1/BRCA2, ATM, or molecular evidence of other homologous recombination deficiency.
  • eAll patients had a deleterious somatic or germline BRCA mutation detected from either central plasma, central tissue, or local testing.
  • fThis includes HSPC and CRPC.
  • AR, androgen receptor-directed therapy; BRCA, breast cancer susceptibility gene; CI, confidence interval; CR, complete response; CRPC, castration-resistant prostate cancer; DOR, duration of response; HSPC, hormone sensitive prostate cancer; IRR, independent radiology review; mCRPC, metastatic castration-resistant prostate cancer; NE, not evaluable; ORR, objective response rate; PCWG3, Prostate Cancer Working Group 3; PR, partial response; PSA, prostate-specific antigen; RECIST v1.1, Response Evaluation Criteria in Solid Tumors. Version 1.1.

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