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ESMO 2018: CheckMate-142 Reports New Data on First-Line Nivolumab Plus Low-Dose Ipilimumab in MSI-H/dMMR Metastatic Colorectal Cancer

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Key Points

  • The objective response rate was 60%, the disease control rate was 84%, and 7% of patients had a complete response.
  • The median duration of response, median progression-free survival, and median overall survival have not yet been reached.
  • The 12-month progression-free survival and overall survival rates were 77% and 83%, respectively.

The combination of nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) could become a new first-line treatment in patients with microsatellite instability–high (MSI-H), mismatch repair–deficient (dMMR) metastatic colorectal cancer, following results from the CheckMate-142 trial reported by Lenz et al at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract LBA18_PR). The combination shrank tumors and had beneficial effects on survival.

Around 4% of metastatic colorectal cancers are MSI-H, or dMMR. Patients with MSI-H tumors have shorter survival (~14–19 months) than those with non–MSI-H tumors (~17–25 months) when treated with chemotherapy in a first-line setting, according to findings published by Heinemann et al in the Journal of Clinical Oncology and Venderbosch et al in Clinical Cancer Research.

More on CheckMate-142

The phase II CheckMate-142 trial previously showed that in patients with MSI-H metastatic colorectal cancer that is resistant to chemotherapy, immunotherapy with nivolumab and low-dose ipilimumab provided durable clinical benefit and manageable side effects, which led to approval of the combination by the U.S. Food and Drug Administration (FDA).

At ESMO 2018, researchers reported the CheckMate-142 results in patients who have received no prior treatment for MSI-H metastatic colorectal cancer. The study enrolled 45 patients. The median age was 66 years, and 51% were male. Patient follow-up reached a median of 13.8 months, and the primary endpoint was objective response rate.

Study Results

The objective response rate was 60%, the disease control rate was 84%, and 7% of patients had a complete response. It took a median of 2.6 months to respond to treatment. The median duration of response, median progression-free survival, and median overall survival have not yet been reached. The 12-month progression-free survival and overall survival rates were 77% and 83%, respectively.

Other trials have tested high-dose ipilimumab combined with nivolumab, but CheckMate-142 used low-dose ipilimumab with nivolumab, which resulted in less toxicity. Treatment-related grade 3 and 4 toxicities were reported in 16% of patients, and 7% discontinued therapy due to treatment-related adverse events.

Study author Heinz-Josef Lenz, MD, FACP, Co-Leader, Gastrointestinal Cancers Program, University of Southern California Norris Comprehensive Cancer Center, said, “The combination of low-dose ipilimumab and nivolumab has a durable clinical response and is well tolerated as first-line treatment in patients with MSI-H metastatic colorectal cancer. The data suggest that nivolumab and ipilimumab may be a first-line treatment option for these patients.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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