Exploratory biomarker analysis of RAS/BRAF somatic mutations and gene expression signatures for predicting treatment effects of aflibercept in the velour trial.

In CMS4, aflibercept was associated with an unexpected trend toward poorer OS (median OS: 13.7 vs. 23 months, HR 2.38, 95% CI 1.15 – 4.89, p = 0.016, q = 0.128), and shorter PFS (median PFS: 5.7 vs. 7.9 months, HR 1.48, 95%CI 0.77 – 2.85, p = 0.230).

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Among iCMS2 tumours, aflibercept was associated with numerically improved outcomes without reaching statistical significance, whereas iCMS3 tumours exhibited a nominally significant PFS benefit (HR 0.66, p = 0.025), but this did not withstand FDR correction ( q = 0.100) and was not accompanied by an OS benefit.

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CMS1 group showed a trend towards PFS benefit from aflibercept (median PFS: 6.6 vs. 3.0 months; HR 0.62, 95% CI 0.39–0.98, p = 0.039, q = 0.156), though OS improvement was modest (median OS: 10.7 vs. 7.4 months; HR 0.88, 95% CI 0.57–1.36, p = 0.564).

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PFS increased from 6.8 to 9.3 months but did not reach statistical significance (HR 0.71, 95% CI 0.42–1.20, p = 0.202) (Fig. 5e, f ).

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2.9 months; HR 0.66, 95% CI 0.45–0.95, p = 0.025, q = 0.100), which approached but did not reach significance after correction for multiple testing, while OS did not show a clear improvement (median OS 9.2 vs. 8.5, HR 0.90, 95% CI 0.63–1.29, p = 0.564) (Fig. 5a, b ).

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