Nivolumab plus ipilimumab improves progression-free survival in metastatic colorectal cancer

1. Progression-free survival was significantly greater in the nivolumab plus ipilimumab group compared to nivolumab alone.

2. Treatment-related adverse events were slightly higher in nivolumab plus ipilimumab.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Microsatellite instability-high metastatic colorectal cancer is an aggressive disease with limited treatment options. Prior findings from the CheckMate 8HW trial showed that the combination of nivolumab and ipilimumab provided superior progression-free survival compared to chemotherapy alone. This randomized controlled trial aimed to evaluate whether nivolumab plus ipilimumab improved progression-free survival compared to nivolumab alone, regardless of prior antineoplastic therapies. The primary outcome of this study was progression-free survival as assessed by blinded independent central review, while the key secondary outcome was the safety and adverse event profile of nivolumab plus ipilimumab. According to study results, nivolumab plus ipilimumab significantly improved progression-free survival compared to nivolumab alone. Although this study was well done, it was limited by an open-label design, which may introduce bias in outcome assessment and patient management.

Click to read the study in The Lancet

Relevant Reading: Nivolumab+AVD in Advanced-Stage Classic Hodgkin’s Lymphoma

In-depth [randomized controlled trial]: Between Aug 16, 2019, and Apr 10, 2023, 1147 patients were assessed for eligibility from 128 hospitals in 23 countries. Included were patients ≥ 18 years with unresectable or metastatic colorectal cancer who were immunotherapy-naïve and had microsatellite instability-high or mismatch repair-deficient status. Altogether, 707 patients (354 to nivolumab plus ipilimumab and 353 to nivolumab alone) were included in the final analysis. The primary outcome of progression-free survival demonstrated a significant improvement with nivolumab plus ipilimumab compared to nivolumab alone (hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.48-0.81, p<0.05). The secondary outcome of treatment-related adverse events showed a similar trend (22% in nivolumab plus ipilimumab vs. 14% in nivolumab-only). Overall, findings from this study suggest that nivolumab plus ipilimumab provides superior progression-free survival and may represent a new standard of care for patients with metastatic colorectal cancer.

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