A clinical collaboration between Bristol-Myers Squibb and Clovis Oncology has been announced, which will evaluate the combination of Opdivo (nivolumab) and Rubraca (rucaparib) in Phase II and III trials for multiple tumour types.
Clinical collaboration
As part of the agreement Phase III clinical trials will be conducted to evaluate Bristol-Myers Squibb’s immunotherapy Opdivo and Clovis oncology poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca for the treatment of advanced ovarian cancer and advanced triple-negative breast cancers. Additionally, the collaboration will include a Phase II study to evaluate the safety and efficacy of the combined therapies in patients with metastatic castration-resistant prostate cancer (mCRPC). This combined option for mCRPC will be conducted as an arm of a larger Bristol-Myers Squibb-sponsored study.
“We are very enthusiastic about studying Rubraca and Opdivo in combination, and the potential to create new treatment options for patients with multiple tumour types, as well as for patients beyond those with BRCA mutations,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “This substantial clinical collaboration in ovarian, triple-negative breast and prostate cancers represents a significant effort by Clovis and Bristol-Myers Squibb to realise that potential.”
“This clinical collaboration addresses areas of unmet medical need where the combination of Opdivo and Rubraca may lead to an additional treatment option for patients with difficult to treat cancers,” added Dr Fouad Namouni, head of Oncology Development, Bristol-Myers Squibb. “We are committed to investigating a wide range of oncology therapies and look forward to studying the combination of Clovis’ PARP inhibitor and our immunotherapy.”
The planned multi-arm clinical trials will be conducted in the US, Europe and possibly additional countries. Clovis will be the study sponsor and conducting party for the ovarian cancer study and Bristol-Myers Squibb will be the study sponsor and conducting party for the breast and prostate cancer studies. All three studies are expected to begin before the end of 2017.
Specific terms of the agreement were not disclosed.