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

SEE SAFETY PROFILE
  • 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.

INDICATION

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Please see full Prescribing Information for additional Important Safety Information.

References:
1. Rubraca. Prescribing information. Clovis Oncology; 2022. 2. Abida W, Patnaik A, Campbell D,et al.Rucaparib in men with metastatic castration-resistant prostate cancer harboring a BRCA1 or BRCA2 gene alteration. J Clin Oncol.2020;38(32)3763-3772. 3. Data on file. Clovis Oncology; Boulder, CO 4. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02952534. Accessed May 21, 2021.

INDICATION

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

SELECT IMPORTANT SAFETY INFORMATION

Read full ISI

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Please see full Prescribing Information for additional Important Safety Information.

Contact Clovis Oncology

Please fill out the form below to be contacted by a Clovis Oncology representative

*This field is required

*Mandatory

By submitting this form, you agree to allow Clovis Oncology Inc. to collect the information provided and to receive product and disease-state information from Clovis, our affiliates, service providers, and co-promotion partners by phone, email, or mail. Clovis or third-party partners working on our behalf will not sell, rent, or otherwise distribute your name and any personally identifiable information. We may share your information with our partners in accordance with our Terms of Use and Privacy Policy.

The information contained in this website is intended for U.S. healthcare professionals only.

By clicking the button below, you acknowledge that you are a U.S. healthcare professional.