TARGETED CONTROLFOR EFFECTIVE OUTCOMES

RUBRACA provides a targeted approach and showed clinically meaningful* responses in patients with BRCA-mutated mCRPC^1,2

Efficacy results were based on the independent radiology review (IRR)–evaluable population (N=81). The primary endpoint was objective response rate (ORR), and a secondary endpoint was duration of response (DOR).¹

*Demonstrated improvements in multiple efficacy outcomes: confirmed ORR by IRR, 46% (95% CI, 35%-57%); median DOR by IRR, 15.5 months (95% CI, 6.4-not reached).

OBJECTIVE RESPONSE RATE^1†

(n=37/81; 95% CI, 35%-57%)

MEDIAN DURATION OF RESPONSE¹

(95% CI, 6.4-not reached)

^†ORR was defined per modified RECIST v1.1 criteria and with no confirmed radiographic bone progression per PCWG3.

VIEW THE FULL TRITON2 STUDY DESIGN

TRITON2 was a multicenter, single-arm, phase 2 clinical trial in patients with germline or somatic BRCA-mutated mCRPC who had been treated with any androgen receptor-directed therapy and a taxane-based chemotherapy.^1,2 Efficacy results were based on the IRR-evaluable population (N=81). The primary endpoint was ORR, and DOR was a secondary endpoint.¹

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.¹

Patient Baseline Characteristics¹

Of the 81 patients in the IRR-evaluable population at baseline:

59% had a somatic BRCA mutation, and 41% had a germline BRCA mutation
88% had a BRCA2 mutation, and 12% had a BRCA1 mutation

No specific androgen receptor-directed therapy was required prior to RUBRACA²

a majority of patients

had a reduction in lesions¹

OF IRR-EVALUABLE PATIENTS HAD A ≥30% REDUCTION IN TARGET LESION SIZE FROM BASELINE

Best Change From Baseline in Sum of Target Lesion(s) in the IRR-Evaluable Population

Source: Abida et al. Eur Urol. 2023;84(3):321-330.

RUBRACA HAS A MANAGEABLE SAFETY AND TOLERABILITY PROFILE²

BRCA, BReast CAncer gene; ECOG, Eastern Cooperative Oncology Group; mCRPC, metastatic castration-resistant prostate cancer; PCWG3, Prostate Cancer Working Group 3; RECIST, Response Evaluation Criteria in Solid Tumours.

REFERENCES: 1. Abida W, Campbell D, Patnaik A, et al. Rucaparib for the treatment of metastatic castration-resistant prostate cancer associated with a DNA damage repair gene alteration: final results from the phase 2 TRITON2 study. Eur Urol. 2023;84:321-330. 2. RUBRACA (rucaparib). Prescribing Information. pharma& Schweiz GmbH. 2023.

Tap for safety information

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

RUBRACA^® (rucaparib) 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.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients (2%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.9%). The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In ARIEL3, of patients with a germline and/or somatic BRCA mutation treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

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 from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. 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 of patients with BRCA-mutated mCRPC 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%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

For medical information inquiries within the U.S., contact pharma& at medinfo.us@pharmaand.com.

You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Alternatively, to report an adverse event or reaction, contact pharma& by calling 1-800-506-8501 or emailing pv@pharmaand.com.

To report a product complaint, contact pharma& at complaints@pharmaand.com.

Please see full Prescribing Information for RUBRACA.

TARGETED CONTROLFOR EFFECTIVE OUTCOMES

RUBRACA provides a targeted approach and showed clinically meaningful* responses in patients with BRCA-mutated mCRPC1,2

Patient Baseline Characteristics1

Of the 81 patients in the IRR-evaluable population at baseline:

RUBRACA HAS A MANAGEABLE SAFETY AND TOLERABILITY PROFILE2

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

SELECT IMPORTANT SAFETY INFORMATION

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RUBRACA provides a targeted approach and showed clinically meaningful* responses in patients with BRCA-mutated mCRPC^1,2

Patient Baseline Characteristics¹

RUBRACA HAS A MANAGEABLE SAFETY AND TOLERABILITY PROFILE²

RUBRACA PATIENT WEBSITE
COMING SOON!

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WEBSITE COMING SOON!