CheckMate 8HW: Excellent results for nivolumab plus ipilimumab in MSI-H/dMMR mCRC

First-line nivolumab plus ipilimumab outperformed standard-of-care chemotherapy in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer (MSI-H/dMMR mCRC). With consistent results across subgroups and a manageable safety profile, nivolumab plus ipilimumab presents a potential novel standard-of-care first-line therapy for this population.

The phase 3 CheckMate 8HW study (NCT04008030) randomised participants with MSI-H/dMMR mCRC 2:2:1 to nivolumab alone, nivolumab plus ipilimumab, or to investigator’s choice chemotherapy to compare these treatment regimens in the first line. The dual primary endpoints were progression-free survival (PFS) of nivolumab plus ipilimumab versus nivolumab monotherapy and PFS of nivolumab plus ipilimumab versus chemotherapy. Prof. Thierry André (Sorbonne University, France) shared the primary results of the comparison between participants who received the combination therapy (n=202) and those who received chemotherapy (n=101) [1].

After a median follow-up of 24.3 months, nivolumab plus ipilimumab was superior to chemotherapy with regard to median PFS (not reached vs 5.9 months; HR 0.21; 95% CI 0.13–0.35; P<0.0001). The 24-month PFS rates were 72% and 14%, respectively.

Grade 3 or 4 treatment-emergent adverse events (TEAEs) were less common in the experimental arm (23% vs 48%). “The safety profile of nivolumab plus ipilimumab was different from that of chemotherapy but consistent with the established profiles of the individual agents,” added Prof. André.

In conclusion, the findings of the CheckMate 8HW trial support nivolumab plus ipilimumab as first-line standard-of-care for patients with MSI-H/dMMR mCRC.

1. André T, et al. Nivolumab plus ipilimumab vs chemotherapy as first-line treatment for micro satellite instability-high/mismatch repair-deficient metastatic colorectal cancer: first results of the CheckMate 8HW study. LBA 768, ASCO Gastrointestinal Cancers Symposium 2024, 18–20 January, San Francisco, CA, USA.

 

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Posted on 13 February, 202428 March, 2024