Dr Biachi on the Growing Treatment Landscape in HCC

Tiago Biachi, MD, PhD, associate member, Department of Gastrointestinal Oncology, Moffitt Cancer Center, discusses the growing treatment landscape for patients with hepatocellular carcinoma (HCC).

In an OncLive® State of the Science Summit™ (SOSS), Biachi and colleagues from Moffitt Cancer Center each gave presentations on topics spanning gastrointestinal cancer care. At the event, Biachi discussed recent updates in the field of HCC, with a specific focus on newly published studies. These studies include the phase 3 COSMIC-312 (NCT03755791), LEAP-002 (NCT03713593), and CELESTIAL (NCT01908426) trials.

In 2008, sorafenib (Nexavar) was FDA approved based on findings from a randomized phase 3 trial comparing the agent with a placebo, Biachi says. For a decade, sorafenib was the only treatment option available for patients with HCC. However, several other treatments have nowgained regulatory approval, he explains. The 2020 FDA approval of atezolizumab (Tecentriq) plus bevacizumab (Avastin) for patients with treatment-naïve unresectable or metastatic HCC was supported by findings from the phase 3 IMbrave150 trial (NCT03434379), which evaluated atezolizumab plus bevacizumab vs sorafenib. Additionally, the 2023 FDA approval of durvalumab (Imfinzi) plus tremelimumab (Imjudo) in patients with unresectable HCC was backed by findings from the phase 3 HIMALAYA study (NCT03298451). However, a direct comparison between these 2 approved regimens is needed, he emphasizes. Researchers have discussed using the cause of liver disease as a surrogate for evaluating responses to different combinations, he adds.

During the SOSS, Biachi delved into 2 studies attempting to combine a TKI with immunotherapy: the aforementioned COSMIC-312 and LEAP-002 studies. COSMIC-312 explored the combination of atezolizumab and cabozantinib vs sorafenib, though this trial did not meet its primary end point of overall survival, he explains. The latter trial, LEAP-002, comparedpembrolizumab (Keytruda) plus lenvatinib (Lenvima) with lenvatinib alone, Biachi says. Notably, these data were surprising because although this combination has been approved for patients with other tumor types, it unfortunately did not benefit those with HCC, Biachi notes.

Moreover, investigators at the SOSS discussed the future of HCC treatment, which is likely to involve various modalities, with ongoing studies exploring combinations of immunotherapies, he concludes.