Date: 2017-09-11
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2017 Congress
Company: Nordic Society for Gynaecologic Oncology
Product: niraparib and bevacizumab
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: platinum-sensitive epithelial ovarian cancer
Therapeutic
area: Cancer - Oncology
Country: Denmark, USA
Trial
details:
- Part 1 (Phase 1): safety and tolerability of bevacizumab-niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS)
- PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease.
- In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone.
- The question is: Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib. (NCT02354131)
Latest
news:
- • On September 11, 2017, Tesaro provided a summary of Zejula® data presented at the 2017 European Society of Medical Oncology (ESMO) Annual Meeting in Madrid. Updated data from the ongoing Phase 2 AVANOVA study of bevacizumab plus niraparib, an Investigator Supported Trial (IST), in patients with platinum sensitive recurrent ovarian cancer (n=12) demonstrated activity and a predictable adverse event profile. In the first cycle (21 days) of the study, patients experienced expected and manageable adverse events including anemia, constipation, fatigue, hypertension, nausea and thrombocytopenia. One dose-limiting toxicity (grade 3 thrombocytopenia) was observed at the highest dose level. Three patients were dose reduced and two patients terminated bevacizumab. Preliminary evidence of activity was demonstrated, with a disease control rate of 92% and response rate of 50%, including 1 CR and 5 PRs. There were five additional patients with stable disease. The median progression-free survival (PFS) was 49 weeks. These data support the potential to combine niraparib plus bevacizumab. Part 2 of the AVANOVA trial continues to enroll patients.
Is
general: Yes
