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Association details:
Biomarker:BRCA2 mutation
Cancer:Prostate Cancer
Drug:Rubraca (rucaparib) (PARP inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor 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.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
05/28/2020
Excerpt:
Rucaparib is a treatment option for patients with mCRPC and a pathogenic BRCA1 and BRCA2 mutation (germline and/or somatic) who have been treated with androgen receptor-directed therapy and a taxane based chemotherapy.
Evidence Level:
Sensitive: B - Late Trials
Title:

Rucaparib or Physician's Choice in Metastatic Prostate Cancer

Published date:
02/23/2023
Excerpt:
At 62 months, the duration of imaging-based progression-free survival was significantly longer in the rucaparib group than in the control group, both in the BRCA subgroup (median, 11.2 months and 6.4 months, respectively; hazard ratio, 0.50; 95% confidence interval [CI], 0.36 to 0.69) and in the intention-to-treat group (median, 10.2 months and 6.4 months, respectively; hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001 for both comparisons)....The duration of imaging-based progression-free survival was significantly longer with rucaparib than with a control medication among patients who had metastatic, castration-resistant prostate cancer with a BRCA alteration.
DOI:
10.1056/NEJMoa2214676
Evidence Level:
Sensitive: B - Late Trials
Title:

Rucaparib for metastatic castration-resistant prostate cancer (mCRPC): TRITON3 interim overall survival and efficacy of rucaparib vs docetaxel or second-generation androgen pathway inhibitor therapy.

Published date:
02/13/2023
Excerpt:
OS maturity was 54% in the BRCA subgroup and 59% in the ITT population….Rucaparib significantly improved rPFS vs either DTX or ABI/ENZ; safety was consistent with prior reports. Interim OS results suggest a trend towards improvement for rucaparib vs DTX or ABI/ENZ in pts with mCRPC and BRCA alterations.
DOI:
10.1200/JCO.2023.41.6_suppl.18
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

TRITON3 Phase 3 Trial of Rubraca® (rucaparib) Achieves Primary Endpoint in Men with Metastatic Castration-Resistant Prostate Cancer with BRCA or ATM Mutations

Published date:
10/03/2022
Excerpt:
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced positive top-line data from the Phase 3, open-label, multicenter, randomized TRITON3 trial demonstrating that Rubraca monotherapy treatment achieved the primary endpoint of significantly improved radiographic progression-free survival (rPFS)...Benefit was observed in both primary efficacy analyses of patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC): first, those who had mutations in BRCA, as well as all patients randomized in the trial, inclusive of mutations in BRCA or ATM (the overall intent-to-treat population (ITT)).
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Clovis Oncology Receives Breakthrough Therapy Designation for Rubraca® (rucaparib) for Treatment of BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer (mCRPC)

Published date:
10/02/2018
Excerpt:
Clovis Oncology, Inc...today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Excerpt:
...- Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
Title:

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Excerpt:
...- Have a deleterious mutation in a BRCA1/2 or ATM gene...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

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

Published date:
06/06/2023
Excerpt:
RITON2 enrolled patients with mCRPC who had progressed on one or two lines of next-generation androgen receptor-directed therapy and one taxane-based chemotherapy....ORR by IRR was 46% (37/81) in the BRCA subgroup (95% confidence interval [CI], 35-57%), 100% (4/4) in the PALB2 subgroup (95% CI, 40-100%), and 25% (3/12) in the Other subgroup (95% CI, 5.5-57%).
DOI:
10.1016/j.eururo.2023.05.021
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

TRIUMPH: Phase II trial of rucaparib monotherapy in patients with metastatic hormone-sensitive prostate cancer harboring germline DNA repair gene mutations.

Published date:
02/13/2023
Excerpt:
12 pts were enrolled, 7 with BRCA1/2 and 5 with CHEK2 muts. The confirmed PSA50 response rate to rucaparib was 41.7% (N=5/12, 95% CI: 19.3-68.1%)...In pts with measurable disease, the ORR was 60% (N=3/5, all with BRCA2). Median rPFS on rucaparib was 10.3 months (95% CI: 4.0 mo - NR)....Rucaparib can induce clinical responses in a biomarker-selected PCa population without concurrent ADT.
DOI:
10.1200/JCO.2023.41.6_suppl.190
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Association of co-occurring gene alterations and clinical activity of rucaparib in patients with BRCA1 or BRCA2 mutated (BRCA+) metastatic castration-resistant prostate cancer (mCRPC).

Published date:
02/08/2021
Excerpt:
Results from TRITON2 showed antitumor activity for rucaparib in patients with BRCA+ mCRPC associated with or without co-occurring alterations in TP53.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

PARP inhibitors as a new therapeutic option in metastatic prostate cancer: a systematic review

Published date:
05/06/2020
Excerpt:
...rucaparib showed a benefit in terms of PSA response rate and ORR in patients with BRCA2 and BRCA1 mutation in a phase-II study.
DOI:
10.1038/s41391-020-0233-3
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Genomic characteristics associated with clinical activity of rucaparib in patients (pts) with BRCA1 or BRCA2 (BRCA)-mutated metastatic castration-resistant prostate cancer (mCRPC).

Published date:
02/14/2020
Excerpt:
Confirmed objective response rate (ORR) in BRCA pts (with investigator-assessed measurable disease) and PSA response rates (in pts with and without measurable disease) are shown in the Table....Responses were observed in patients with germline or somatic alterations in BRCA1 or BRCA2.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Preliminary Results from TRITON2: A Phase 2 Study of Rucaparib in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Associated with Homologous Recombination Repair (HRR) Gene Alterations

Published date:
10/19/2018
Excerpt:
Of patients with a BRCA1/2 alteration and measurable disease at baseline, 44.0% (11/25) had a confirmed objective response by investigator assessment (Table 2; Figure 4)
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration

Excerpt:
ORRs were similar for patients with a germline or somatic BRCA alteration and for patients with a BRCA1 or BRCA2 alteration, while a higher PSA response rate was observed in patients with a BRCA2 alteration….Rucaparib has antitumor activity in patients with mCRPC and a deleterious BRCA alteration...
DOI:
10.1200/JCO.20.01035