25 May 2021 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high (MSI-H) metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy, US-based Bristol Myers Squibb (NYSE: BMY) said.

The opinion was based on data from the Phase 2 CheckMate -142 trial.

The European Commission, which is authorized to approve medicines for the European Union, will now review the CHMP recommendation.

Opdivo plus Yervoy received approval from the US Food and Drug Administration in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. 

Opdivo plus Yervoy was also approved in Japan by the Pharmaceuticals and Medical Devices Agency in September 2020 for the treatment of MSI-H unresectable, advanced or recurrent colorectal cancer progressing after cancer chemotherapy.

CheckMate -142 included a multicenter, non-randomized, open-label cohort investigating Opdivo plus Yervoy in patients with mismatch repair deficient or microsatellite instability–high (MSI-H) metastatic colorectal cancer whose disease had progressed during or after prior treatment with fluoropyrimidine, oxaliplatin and irinotecan.

In this combination cohort, patients received Opdivo 3 mg/kg with Yervoy 1 mg/kg every three weeks for four doses, followed by Opdivo 3 mg/kg as a single agent every two weeks until disease progression, death, or unacceptable toxicity.

Efficacy outcome measures included objective response rate as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response.

Colorectal cancer is a cancer that develops in the colon or the rectum, which are part of the body's digestive or gastrointestinal system. Globally, CRC is the third most commonly diagnosed cancer in the world.

In 2020, it is estimated that there were approximately 1.931m new cases of the disease and that it will be the second leading cause of cancer-related deaths among men and women combined.

Mismatch repair deficiency occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors.

Approximately 5% of metastatic CRC patients have dMMR or MSI-H tumors. Metastatic CRC patients with these biomarkers are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.