Clinical Trials

Date: 2017-03-23

Type of information: Initiation of development program

phase: 2,3

Announcement: initiation of development program

Company: Tesaro (US - MA)

Product: niraparib

Action mechanism:

• poly ADP ribose polymerase PARP inhibitor/PARP inhibitor. Niraparib is an orally administered poly polymerase (PARP) inhibitor, currently in late-stage development for patients with metastatic breast cancer and ovarian cancer. PARP proteins play a key survival role in DNA repair in cancer cells. By inhibiting PARP, certain defective cancer cells are not able to repair themselves, leading to cell death. A portion of men with prostate cancer have these defective cancer cells and may benefit from use of a PARP inhibitor, either alone, or in combination with other treatments.

Disease: front-line ovarian cancer, lung cancer, breast cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On March 27, 2017, Tesaro announced an expansion of its niraparib clinical development program. Following the landmark results of the Phase 3 NOVA trial of niraparib, a comprehensive portfolio review, and the FDA approval of Zejula™ (niraparib) for patients with recurrent ovarian cancer, Tesaro is implementing its plans to initiate registration strategies in the settings of metastatic ovarian, breast and lung cancers.
• Breast International Group (BIG) and the European Organisation for Research and Treatment of Cancer (EORTC) are currently conducting the BRAVO study assessing niraparib in patients with breast cancer who are germline BRCA mutation carriers Following a recent interim analysis of data by the independent data monitoring committee (IDMC), Tesaro believes the BRAVO study is unlikely to produce data that is interpretable and therefore suitable for registration in this indication. A large number of patients in the chemotherapy control arm did not continue in the trial long enough to receive their first radiological scan, which is required to assess disease progression, resulting in an unusually high rate of censoring in the control arm.
• At this time, Tesaro believes this is likely associated with the desire of patients who carry germline BRCA mutations to be treated with a PARP inhibitor rather than chemotherapy and the increased availability of PARP inhibitors. A final determination as to whether the planned enrollment in BRAVO should be completed will be made by the Steering Committee in the near term. No safety concerns have been noted by the IDMC with respect to niraparib. Tesaro expects the results and experience gained from the BRAVO trial to be supportive of the planned trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Approximately 15-20% of women with breast cancer have triple negative breast cancer.
• The expanded niraparib clinical development program now includes the following:
• Ovarian Cancer: OvCa 3000-03-003: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to niraparib in first-line maintenance treatment of patients with advanced ovarian cancer who have responded to platinum induction therapy.
• OvCa 3000-03-002: A Phase 3 clinical trial of niraparib in combination with bevacizumab in comparison to standard of care in patients with a first recurrence of ovarian cancer.
• PRIMA: A Phase 3 clinical trial of niraparib in patients with advanced ovarian cancer who have responded to platinum induction therapy.
• TOPACIO: A Phase 2 trial to evaluate the preliminary safety and efficacy of niraparib plus Keytruda® in patients with triple negative breast cancer and in patients with platinum resistant recurrent ovarian cancer being conducted by Tesaro in collaboration with Merck&Co.
• QUADRA: A registration trial of niraparib for the treatment of patients with recurrent ovarian cancer who have received three or four regimens of therapy.
• AVANOVA: An NSGO (Nordic Society of Gynaecological Oncology) Phase 1/2 trial (in collaboration with ENGOT) evaluating niraparib plus bevacizumab in patients with recurrent ovarian cancer.
• Breast Cancer: TNBC 3000-03-004: A Phase 3 clinical trial of niraparib in combination with anti- PD-1 antibody in comparison to standard of care in patients with advanced triple negative breast cancer.
• Lung Cancer: Lung 3000-02-001: A Phase 2 clinical trial of niraparib in combination with an anti-PD-1 antibody in patients with advanced NSCLC and niraparib alone in patients with advanced squamous cell carcinoma of the lung.
• Lung 3000-03-001: A Phase 3 clinical trial of niraparib in combination with an anti-PD-1 antibody in comparison to anti-PD-1 alone in patients with advanced NSCLC and high levels of PDL-1 tumor expression.

   

Is general: Yes