Date: 2017-07-31
Type of information: Clinical research agreement
Compound:
- enzyme inhibitor/PARP inhibitor/monoclonal antibody/immune chekcpoint inhibitor.
- Rucaparib is an orally-available, small molecule PARP 1 (poly ADP-ribose polymerase) and PARP2 inhibitor being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as “BRCA-like” or “BRCAness.”
- BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. By blocking PARP enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.
- Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. By blocking this pathway, nivolumab enables the immune system to resume its ability to recognize, attack and destroy cancer cells.
Company: BMS (USA - NY) Clovis Oncology (USA - CO)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
Disease: advanced ovarian cancer, advanced fallopian tube cancer, primary peritoneal canceradvanced triple-negative breast cancer (TNBC), metastatic castration-resistant prostate cancer (mCRPC)
Details:
- • On July 31, 2017, BMS and Clovis Oncology announced that they have entered into a clinical collaboration agreement to evaluate the combination of Opdivo® and Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca® (rucaparib) in Phase 2 and pivotal Phase 3 clinical trials in multiple tumor types. Pivotal phase 3 clinical trials will evaluate the combination in advanced ovarian cancer and in advanced triple-negative breast cancers (TNBC). A first-line maintenance treatment study will evaluate Rubraca® + Opdivo®, Rubraca®, Opdivo® and placebo in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer who have completed platinum-based chemotherapy. Another first-line maintenance treatment study will evaluate Rubraca® + Opdivo®, Rubraca®, Opdivo® and chemotherapy in patients with stage IV or recurrent locally advanced inoperable TNBC associated with a homologous recombination deficiency (HRD).
- The collaboration will also include a Phase 2 study to evaluate the safety and efficacy of Opdivo® in combination with Rubraca® in patients with metastatic castration-resistant prostate cancer (mCRPC). The Opdivo® + Rubraca® combination in mCRPC will be conducted as an arm of a largerBMS-sponsored study.
- The planned multi-arm clinical trials will be conducted in the U.S., Europe and possibly additional countries. Clovis will be the study sponsor and conducting party for the ovarian cancer study and BMS will be the study sponsor and conducting party for the breast and prostate cancer studies. Specific terms of the agreement were not disclosed. All three studies are expected to begin before the end of 2017.
Financial terms:
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Is general: Yes
