Atezolizumab plus bevacizumab has been recently approved as new first-line standard of care for patients with unresectable hepatocellular carcinoma (HCC). We perform a real word study to evaluate the impact in term of outcome of the inclusion criteria from the IMbrave150 trial on safety and efficacy of treatment.
We enrolled patients treated with atezolizumab plus bevacizumab for unresectable HCC from 4 different countries. No specific inclusion and exclusion criteria were applied, except for the absence of previous systemic therapies for HCC. The whole population was split in two groups according to the concordance with the inclusion criteria as reported in the IMbrave150 trial in “IMbrave150-in” and “IMbrave150-out” patients, and survival outcomes in the two groups of patients have been evaluated.
766 patients were enrolled in the study: 561/766 (73%) were included in the “IMbrave150-in” group, and 205/766 (27%) were included in the “IMbrave150-out” group. mOS and mPFS were 16.3 Vs 14.3 months (HR 0.48, 0.35–0.65; p < 0.0001] and 8.3 Vs 6.0 months (HR 0.79, 0.63–0.99; p = 0.0431) in “IMbrave150-in” and “IMbrave150-out” patients, respectively. Multivariate analysis confirmed that patients included in the “IMbrave150-in” group had significantly longer OS compared to patients included in the “IMbrave150-out” group (HR 0.76, 0.47-0.97; p=0.0195). In “IMbrave150-in” patients the ALBI grade was not significantly associated to OS, whereas in “IMbrave150-out” patients, those with an ALBI grade 1 reported a significant benefit in terms of OS compared to those with an ALBI grade 2 (16.7 Vs 5.9 months HR 4.40,2.40-8.08, p>0.0001). No statistically differences were reported in “IMbrave150-in” and “IMbrave150-out” groups in terms of safety profile.
The accordance with the inclusion criteria of the IMbrave150 trial positively impact prognosis of patients receiving Atezolizumab plus bevacizumab. Between patients who do not meet the inclusion criteria, those reporting an ALBI grade of 1 could benefit from treatment with the combination.
M. Rimini.
Has not received any funding.
All authors have declared no conflicts of interest.