Atezolizumab/Bevacizumab Shows Survival and QOL Benefit in HCC

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EP: 1.Atezolizumab/Bevacizumab Shows Survival and QOL Benefit in HCC

EP: 2.Atezolizumab/Bevacizumab Benefit Potentially Extends to Child-Pugh B HCC

Stacey Stein, MD, associate professor of internal medicine at the Yale School of Medicine and assistant medical director of the clinical trials office at Yale Cancer Center, discusses the background and outcomes of the IMbrave150 trial (NCT03434379) of atezolizumab (Tecentriq) plus bevacizumab (Avastin) in patients with advanced hepatocellular carcinoma (HCC).

According to Stein, before this combination was approved, patients with advanced HCC received tyrosine kinase inhibitors (TKIs) such as sorafenib (Nexavar), which showed efficacy but significant adverse events (AEs). The IMbrave150 trial followed a phase 1b trial (NCT02715531) where atezolizumab/bevacizumab showed a higher response rate than prior TKIs had in trials.

The phase 3 trial randomly assigned 336 patients to receive the combination vs 165 to receive sorafenib. At 15.6 months median follow-up, the median overall survival (OS) was 19.2 months with the combination vs 13.4 months with sorafenib, with a median progression-free survival (PFS) of 6.9 months vs 4.3 months, respectively. The toxicity profile was also favorable, Stein said.

Additionally, patient-reported quality-of-life (QOL) outcomes were reported from the trial population. The risk of deterioration for prespecified generic cancer symptom scales for appetite loss, diarrhea, fatigue, and pain were reduced with atezolizumab/bevacizumab. Disease-specific symptom scales for fatigue and pain also showed significant reduction, though it did not show statistically significant reduction in jaundice vs sorafenib. The mean score changes from baseline were better for the combination vs sorafenib in terms of QOL, role functioning, and physical functioning.

Transcription:

0:08 | Prior to immune therapy, we gave patients only TKIs, which have some benefit, but also several [AEs]. The combination of atezolizumab and bevacizumab in the phase 1 study had showed a higher response rate than we had ever seen with TKIs. So there was a lot of excitement over comparing this combination [with] sorafenib.

0:38 | The IMbrave150 study was a randomized phase 3 study that looked at the combination vs sorafenib. There were over 300 patients [who] enrolled in the study, and we saw an impressive improvement in both PFS and OS with a favorable toxicity profile. Patients were also asked to report on their QOL, and they felt that their QOL was significantly better on the immune therapy combination than on sorafenib. So really all of the indicators that we were looking for in terms of PFS, OS, AEs, and QOL were all improved on this regimen compared [with] sorafenib.