Dr Taieb on Findings from a Post-hoc Analysis of TAS-102 Plus Bevacizumab in Refractory mCRC

Julien Taieb, MD, PhD, professor of medicine, Université Paris Cité, The Hôpital Européen Georges-Pompidou, Université de Paris, discusses key findings from a post-hoc analysis of the phase 3 SUNLIGHT trial (NCT04737187) of combination of trifluridine/tipiracil (TAS-102; Lonsurf) with bevacizumab (Avastin) in patients with refractory metastatic colorectal cancer (mCRC).

Data from a post-hoc analysis presented at the 2023 ASCO Annual Meeting indicated that TAS-102 plus bevacizumab prolonged overall survival (OS) vs TAS-102 alone in patients who maintained their ECOG performance status. These results were consistent with what was previously reported in the overall study population, Taieb says. In the post-hoc analysis, patients with maintained ECOG performance status treated with the combination experienced a median OS of 10.58 months vs 8.71 months for those given TAS-102 alone (HR, 0.78; 95% CI, 0.61-0.99).

Notably, investigators had previously presented data from the phase 3 trial at the 2023 Gastrointestinal Cancers Symposium, which showed that median OS was improved with the addition of bevacizumab to TAS-102 (10.8 months) vs TAS-102 alone (7.5 months; HR, 0.61; 95% CI, 0.49-0.77; P < .001). Taieb notes that this 3.3-month improvement was not expected in a such a heavily pretreated patient population.

Prior data from the overall population showed that the median progression-free survival (PFS) was 5.6 months in the experimental arm vs 2.4 months in the control arm (HR, 0.61; 95% CI, 0.49-0.77; P < .001). In the post-hoc analysis, patients who maintained an ECOG performance status of 0 or 1 experienced a median PFS of 5.22 months with TAS-102 plus bevacizumab vs 2.55 months for TAS-102 alone (HR, 0.49; 95% CI, 0.40-0.61).

Notably, the median time to worsening of ECOG performance status was 9.3 months in the TAS-102/bevacizumab arm compared with 6.3 months in the TAS-102 arm (HR, 0.54; 95% CI, 0.43-0.67; P < .001).