BMS and Clovis to initiate Phase II and III combination trials for oncology


Bristol-Myers Squibb (BMS) has signed a clinical collaboration agreement to investigate the combination of its Opdivo (nivolumab) with Clovis Oncology’s Rubraca in a Phase II and two Phase III clinical trials to treat various types of tumours.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, while Rubraca is an oral, small molecule inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes such as PARP-1, PARP-2 and PARP-3.

Set to be initiated by the end of this year, the multi-arm clinical trials will be initially performed in the US and Europe, with plans to extend to other countries.

Bristol-Myers Squibb oncology development head Fouad Namouni said: “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.

“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.”

A Phase III trial will assess Opdivo and Rubraca as monotherapies, as well as a combination therapy in newly diagnosed subjects with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer.

"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."

Another Phase III trial will evaluate the same in stage IV or recurrent locally advanced inoperable triple-negative breast cancer (TNBC) patients with a homologous recombination deficiency (HRD).

The ovarian cancer trial will include placebo, while the TNBC trial will compare the drug candidates’ effects with chemotherapy.

Additionally, the safety and efficacy of the combination will be investigated in a Phase II trial in metastatic castration-resistant prostate cancer (mCRPC) patients.

BMS will fund and perform the breast and prostate cancer trials, while Clovis will sponsor and conduct the ovarian cancer trial.


Image: Micrograph of a mucinous ovarian tumour. Photo: courtesy of Nephron.