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35820411000001101

New Medicines

Rubraca Metastatic castration resistant prostate cancer with a deleterious BRCA mutation - monotherapy

Information

Rubraca
Licence extension / variation
Clovis Oncology
Clovis Oncology

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
May 20Approved in US as monotherapy treatment for patients with BRCA1/2-mutant, metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy [8].
Jan 20FDA grants priority review to sNDA for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, based on data from TRITON clinical program [7].
Oct 18Granted Breakthrough therapy status in the US based on initial efficacy and safety results from the ongoing PII trial, TRITON 2 (NCT02952534). Initial data from this study will be presented for the first time at the 2018 European Society for Medical Oncology (ESMO) Congress later this month [1]

Category

Poly(ADP-ribose) polymerase (PARP) inhibitor
Approx 345,000 men in Europe were diagnosed with prostate cancer in 2012 and estimates indicate >164,000 men in the US will be diagnosed with prostate cancer in 2018. Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer (mCRPC), is an incurable disease, usually associated with poor prognosis. Approximately 12% of mCRPC patients have a deleterious mutation in BRCA1 or BRCA2 [1].
Metastatic castration resistant prostate cancer with a deleterious BRCA mutation - monotherapy
Oral

Further information

Yes

Trial or other data

Jul 21Recruitment continues in PIII TRITON 3 [10].
Dec 20PIII TRITON 3 study continues to recruit [9].
Dec 19PIII TRITON 3 study is recruiting; timescales unchanged [6].
Nov 18PIII TRITON 3 study is recruiting (NCT02975934) [5].
Oct 18Results of TRITON 2 reported at the annual European Society for Medical Oncology (ESMO) meeting, where the company highlighted results showing that rucaparib provoked responses in 44% of patients with BRCA 1/2 mutated tumours. It also significantly decreased the levels of prostate-specific antigen (PSA) in 51% of evaluable patients with BRCA 1/2 alterations [3]. 25/12/2018 08:58:54
Jan 17PIII multicentre, randomised, open label trial (NCT02975934; TRITON3) commenced to investigate efficacy of rucaparib vs physician´s choice of therapy for patients with metastatic castration resistant prostate cancer associated with homologous recombination deficiency. Enrolment is planned for approx 400 patients. The primary end point is defined as the radiologic progression-free survival, confirmed by independent radiology review (IRR). Estimated primary completion end date is Feb 2022 [2].
Nov 16PII TRITON 2 trial in patients with metastatic castration resistant prostate cancer starts (CO-338-052; NCT02952534). The trial will evaluate the safety and efficacy of oral rucaparib in patients with metastatic castration-resistant prostate cancer, including patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes. The primary end points of the trial are radiologic overall response rate in patients with measurable disease and PSA response rate in patients who do not have measurable disease. The open-label trial is enrolling approximately 160 patients in the US, Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, the UK [4].

RubracaOvarian cancer - first line maintenance in newly diagnosed patients in response to chemotherapy - monotherapy

Information

Rubraca
Licence extension / variation
Clovis Oncology
Clovis Oncology

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Poly(ADP-ribose) polymerase (PARP) inhibitor
There are around 7,400 new ovarian cancer cases in the UK every year. Almost 6 in 10 ovarian cancer cases are diagnosed at a late stage. Incidence rates for ovarian cancer have been projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035 [1].
Ovarian cancer - first line maintenance in newly diagnosed patients in response to chemotherapy - monotherapy
Oral

Further information

Yes

Evidence based evaluations

RubracaOvarian cancer - first line maintenance in newly diagnosed patients in response to chemotherapy - with nivolumab

Information

Rubraca
Licence extension / variation
Clovis Oncology
Clovis Oncology

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Poly(ADP-ribose) polymerase (PARP) inhibitor
There are around 7,400 new ovarian cancer cases in the UK every year. Almost 6 in 10 ovarian cancer cases are diagnosed at a late stage. Incidence rates for ovarian cancer have been projected to rise by 15% in the UK between 2014 and 2035, to 32 cases per 100,000 females by 2035 [1].
Ovarian cancer - first line maintenance in newly diagnosed patients in response to chemotherapy - with nivolumab
Bladder instillation