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Bristol-Myers Squibb (BMS), Ono Pharmaceutical, and Bayer have signed a clinical collaboration agreement to trial a combination therapy for the treatment of microsatellite stable metastatic colorectal cancer (MSS mCRC).

The agreement will see BMS and Ono’s anti-PD-1 immune checkpoint inhibitor Opdivo (nivolumab) combined with Bayer’s kinase inhibitor Stivarga (regorafenib).

Opdivo holds approvals for the treatment of various cancers, including microsatellite instability-high (MSI-H) metastatic colorectal cancer that fails to respond to fluoropyrimidine, oxaliplatin, and irinotecan therapy.

Stivarga is indicated for metastatic colorectal cancer (CRC) patients who previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR treatment.

Bristol-Myers Squibb oncology development head Fouad Namouni said: “We continue to invest in innovative approaches to maximise the potential of our pipeline, and interrogate new combinations to help more patients with cancers typically not responsive to I-O therapy.

“We are looking forward to a strong collaboration to investigate nivolumab with regorafenib, with the goal of serving more patients who have cancer.”

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BMS noted that regorafenib monotherapy led to an overall survival benefit compared to placebo in the Phase III CORRECT clinical trial.

A retrospective analysis from this trial further demonstrated the drug’s activity, irrespective of micro-satellite status, though responses were reported to be limited.

Initial results from the regorafenib and nivolumab combination are said to have shown promise.

BMS added that results from the Phase Ib REGONIVO study conducted in Japan revealed encouraging preliminary efficacy results with the combination therapy.

Bayer Pharmaceuticals senior vice-president and Oncology Development head Scott Fields said: “The data seen in REGONIVO warrant further exploration of the combination of regorafenib and nivolumab in patients with colorectal cancer.”

The partners did not disclose further terms of their alliance.