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Spotlight

This roundtable series examines combination therapy for treatment-naive patients with unresectable or metastatic hepatocellular carcinoma, as discussed by key opinion leaders and participants at virtual live events.

Monoclonal Antibodies Used in Combination for HCC

video of Stacey Stein discussing atezolizumab/bevacizumab, IMbrave150 and real-world results

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 patient population and outcomes of the IMbrave150 trial (NCT03434379) of atezolizumab (Tecentriq) plus bevacizumab (Avastin) for patients with advanced hepatocellular carcinoma (HCC).

In the phase 3 trial, 501 patients were randomly assigned on a 2:1 basis to receive atezolizumab/bevacizumab or sorafenib (Nexavar). At a median follow-up of 15.6 months, the coprimary end point of overall survival (OS) was met with a median OS of 19.2 months with atezolizumab/bevacizumab compared with 13.4 months with sorafenib, a difference of 5.8 months (HR, 0.66; 95% CI, 0.52-0.85; descriptive 

 < 0.001). This was a significantly longer OS than what was seen in prior trials, Stein said.

According to Stein, trials of treatments for patients with advanced and unresectable HCC, including IMbrave150, focus on patients with Child-Pugh A cirrhosis or those without cirrhosis, as opposed to those patients with Child-Pugh B or C who are more likely to have poor outcomes regardless of treatment. These patients with a good performance status and liver function don’t represent the real-world population with HCC; however, several retrospective analyses of real-world patients have shown modest efficacy and responses in the Child-Pugh B population. Although toxicities need to be monitored more closely in these patients with poor liver function, they may also benefit from the combination.

The OS was improved by a few months to a median OS of [19.2] months and these were numbers that we have never previously seen in this disease, so we really started to move the needle. In terms of the patient population that was selected, trials in HCC…usually focus only on patients with Child-Pugh A cirrhosis or patients without cirrhosis, and so overall, it's a well-compensated patient population with good performance status and good liver function, which may not always represent all of the patients we see in the real world in clinic. But there [are] some data that show that we're able to treat patients with Child-Pugh B disease without increased harm, and they still get a benefit from the regimen.

Stacey Stein, MD, discusses the patient population and outcomes of the IMbrave150 trial of atezolizumab plus bevacizumab for patients with advanced hepatocellular carcinoma. 

imbrave150 study background and endpoints for QOL

Atezolizumab/Bevacizumab Shows Survival and QOL Benefit in 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.

 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.

 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.

Stacey Stein, MD, discusses the background and outcomes of the IMbrave150 trial of atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma. 