Following AR-targeted therapy and chemotherapy, where do you guide the treatment journey for patients with mCRPC?

Rethink limits

with Rubraca

A first-in-class, oral therapy for a genetically defined population of patients with BRCAmut+ mCRPC1
Man helping an elder man walk up the mountain where the sun is brighter

Demonstrated
Anti-Tumor Efficacy

44% of patients had a response (95% CI: 31, 57)1 See efficacy data
The number 2 in front of a horizontal timeline bar, indicating demonstrated durability

Demonstrated
Durability

Several responses remained ongoing at 2 years
(95% CI: 6.4, NE)
Medical shield icon

Established and
Manageable Safety Profile

The majority of adverse reactions and lab abnormalities were Grades 1 or 21
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Rubraca Prostate Cancer (mCRPC) Resources

Treatment education, access, and reimbursement resources for your practice and patients.

BRCA Mutations in Metastatic Castration-Resistant
Prostate Cancer (mCRPC)

More of your prostate cancer patients may have a BRCA mutation than you think3

BRCA mutations may be present in

12% (~1 in 8)

of patients with mCRPC3

Germline and somatic BRCA mutations have near equal distribution4-6

Pie chart of somatic mutations and germline mutations

Men with BRCAmut+ associated prostate cancer
are known to have a more aggressive disease7,8

BRCA1 mutations icon
In a retrospective analysis of prostate cancer outcomes in patients with germline BRCA1 or BRCA2 mutations and noncarriers, BRCA carriers had a significantly more aggressive disease than noncarriers7
BRCA metastatic spread icon
BRCA carriers were more likely to present
with a Gleason score* ≥8, advanced stage disease, nodal involvement, and metastatic spread7
DNA helix mutations icon
Mutations can occur in both the BRCA1 and BRCA2 genes, and both can lead to more aggressive prostate cancer8

To Help Identify mCRPC Patients at
Greater Risk of Their Disease, Test Tumor DNA for Both Somatic and Germline BRCA Mutations3,6,7

Scientist performing genetic testing with a cotton swab and vial

BRCA Genetic Testing in Prostate Cancer
Can Identify Patients Who May Benefit From
Targeted Treatments1

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend genetic testing for BRCA1/2 mutations in appropriate prostate cancer patients9

Germline Testing9

Recommended for:

  • All men with high-risk, very high-risk, regional, or metastatic prostate cancer, regardless of family history
  • Men with prostate cancer and a suspicious family history of the presence of intraductal/cribriform histology

Somatic Testing9

Recommended for:

  • Men with metastatic prostate cancer

Considered for:

  • Men with regional prostate cancer

Somatic testing may require repetition when prostate cancer progresses after treatment

BRCA mutations can be detected using tests that analyze tissue or circulating tumor DNA from blood1,10
  • *
    The Gleason score ranges from 2-10 and is a measure of whether tissue biopsies look more like normal tissue (lower score) or abnormal tissue (higher score).
  • Two tissue biopsies are each graded based on appearance from 1-5 and added together to generate the Gleason score.
  • AR=androgen receptor-directed therapy; BRCA=breast cancer susceptibility gene; BRCAmut+=BRCA-mutation positive; mCRPC=metastatic castration-resistant prostate cancer.

Anti-Tumor Efficacy

A first-in-class, oral therapy for a genetically defined population of patients with BRCAmut+ mCRPC1

Explore the data

INDICATIONS

Rubraca is indicated:

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.

Reference: 1. Rubraca [prescribing information]. Boulder, CO; Clovis Oncology2. Data on file. Clovis Oncology; Boulder, CO. 3. Abida W, Armenia J, Gopalan A, et al. Prospective genomic profiling of prostate cancer across disease states reveals germline and somatic alterations that may affect clinical decision making. JCO Precis Oncol. 2017. Epub;1-26. 4. Lang SH, Swift SL, White H, Misso K, Kleijnen J, Quek RGW. A systematic review of the prevalence of DNA damage response gene mutations in prostate cancer. Int J Oncol. 2019;55(3):597-616. 5. Robson ME, Bradbury AR, Arun B, et al. American Society of Clinical Oncology policy statement update: genetic and genomic testing for cancer susceptibility. J Clin Oncol. 2015;33(31):3660-3667. 6. Cheng HH, Sokolova AO, Schaeffer EM, Small EJ, Higano CS. Germline and somatic mutations in prostate cancer for the clinician. J Natl Compr Canc Netw. 2019;17(5):515-521. 7. Castro E, Goh C, Leongamornlert D, et al. Effect of BRCA mutations on metastatic relapse and cause-specific survival after radical treatment for localised prostate cancer. Eur Urol. 2015;68(2):186-193. 8. Castro E, Goh C, Olmos D, et al. Germline BRCA mutations are associated with higher risk of nodal involvement, distant metastasis, and poor survival outcomes in prostate cancer. J Clin Oncol. 2013;31(14):1748-1757. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 19, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 10. Foundation Medicine. FoundationOne Liquid technical specifications. https://assets.ctfassets.net/vhribv12lmne/3SPYAcbGdqAeMsOqMyKUog/4e0d771e88afc920dc1a6f0515e2ff83/F1L_TechnicalInformation_10.pdf. Accessed March 18, 2020.

INDICATIONS

Rubraca is indicated:

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.

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