Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) plus Yervoy (ipilimumab) for Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy

Rhea-AI Summary

Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency's CHMP recommended approval of Opdivo (nivolumab) with Yervoy (ipilimumab) for adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior chemotherapy. This decision stemmed from the Phase 2 CheckMate -142 trial. The European Commission will review this recommendation. This combination has previously received FDA approval in July 2018 and Japan in September 2020, highlighting its significance in addressing a critical treatment gap.

Positive

• CHMP recommendation supports the approval of Opdivo plus Yervoy for dMMR or MSI-H mCRC, addressing a significant unmet need.
• Prior approvals by FDA and PMDA enhance market potential and establish credibility of the treatment.

Negative

• None.

Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy. The opinion was based on data from the Phase 2 CheckMate -142 trial. The European Commission (EC), which is authorized to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“Metastatic colorectal cancers with mismatch repair deficient or microsatellite instability-high biomarkers can be difficult to treat, and patients who progress on or after first-line chemotherapy still face a great unmet need despite overall progress in the field,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. "The CHMP’s positive opinion further supports our goal to advance rational combinations that target distinct but complementary immune pathways. We look forward to the EC’s decision later this year and are excited by the potential positive impact this novel combination could have for patients in need throughout the EU.”

Opdivo plus Yervoy received approval from the U.S. Food and Drug Administration (FDA) 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 (PMDA) in September 2020 for the treatment of MSI-H unresectable, advanced or recurrent colorectal cancer progressing after cancer chemotherapy.

About CheckMate -142

CheckMate -142 included a multicenter, non-randomized, open-label cohort investigating Opdivo plus Yervoy in patients with mismatch repair deficient (dMMR) or microsatellite instability–high (MSI-H) metastatic colorectal cancer (mCRC) 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 (ORR) as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response (DoR).

About dMMR or MSI-H Colorectal Cancer

Colorectal cancer (CRC) 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 1,931,000 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 (dMMR) 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.

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FAQ

What is the latest development for Bristol Myers Squibb's stock (BMY) regarding Opdivo?

Bristol Myers Squibb announced a positive CHMP recommendation for Opdivo in combination with Yervoy for certain colorectal cancer patients.

When was Opdivo and Yervoy approved for colorectal cancer?

Opdivo plus Yervoy received FDA approval in July 2018 and was approved by Japan's PMDA in September 2020.

What is the CheckMate -142 trial in relation to BMY?

The CheckMate -142 trial investigated the effectiveness of Opdivo plus Yervoy in patients with dMMR or MSI-H metastatic colorectal cancer.

How does the CHMP's recommendation impact BMY stock?

The CHMP's recommendation may positively influence BMY stock by enhancing the company's prospects in the colorectal cancer treatment market.

What is the significance of the dMMR or MSI-H status in colorectal cancer?

dMMR or MSI-H tumors represent approximately 5% of metastatic CRC cases and are associated with poorer prognosis and reduced efficacy of conventional therapies.