HCC

Panelists discuss how lenvatinib has significantly impacted the systemic therapy landscape for hepatocellular carcinoma (HCC) across different stages. As a first-line treatment, it offers a viable alternative to sorafenib, demonstrating noninferior overall survival with improved progression-free survival and response rates. Its role extends to combination regimens and advanced-stage disease management.

Panelists discuss how, when a patient progresses to second-line therapy, key considerations include prior treatment response, toxicity, patient comorbidities, and therapeutic goals. Lenvatinib shows potential beyond first-line treatment, offering efficacy in patients progressing on systemic therapies, with emerging data supporting its role in treatment sequencing.

Panelists discuss how ongoing trials in first-line advanced hepatocellular carcinoma (HCC) may reshape treatment paradigms, influencing tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI) use. Patient selection depends on clinical (liver function, ECOG status) and biological (PD-L1, VEGF expression) factors. Lenvatinib remains a key TKI, balancing efficacy and safety. As emerging regimens (CARES-310, CheckMate-9DW) gain traction, lenvatinib’s role evolves, with experts assessing its place in monotherapy and combinations.

Panelists discuss how current first-line systemic therapies for advanced hepatocellular carcinoma (HCC) include atezolizumab + bevacizumab and durvalumab + tremelimumab, replacing tyrosine kinase inhibitors (TKIs) like sorafenib and lenvatinib. Emerging combinations with anti–PD-L1 agents enhance efficacy. TKI + immune checkpoint inhibitor (ICI) combinations offer synergistic benefits but pose toxicity, cost, and biomarker challenges.

The FDA has issued a complete response letter for rivoceranib plus camrelizumab as a first-line treatment for unresectable hepatocellular cancer.

An expert discusses how, for advanced unresectable hepatocellular carcinoma (uHCC), clinicians monitor treatment efficacy through imaging, α-fetoprotein levels, and tolerability. Treatment decisions are guided by response assessment, adverse events, and liver function. First-line (1L) options include tyrosine kinase inhibitors and immunotherapy combinations, with promising trials exploring novel immune combinations and targeted approaches that may reshape the treatment landscape.

Panelists discuss how emerging evidence suggests that combining transarterial chemoembolization (TACE) with systemic therapy could redefine the standard of care for hepatocellular carcinoma (HCC). Trial outcomes may drive shifts toward more personalized locoregional approaches. However, challenges in implementation include optimizing patient selection, managing toxicity, and ensuring multidisciplinary coordination.

Panelists discuss how the role of systemic therapy in intermediate-stage hepatocellular carcinoma (HCC) is evolving with combinations like immunotherapy and targeted agents enhancing locoregional treatment. LEAP-012 and EMERALD-1 evaluate lenvatinib + pembrolizumab and durvalumab-based regimens with transarterial chemoembolization (TACE), respectively. Their findings may redefine treatment paradigms, improving outcomes and expanding therapeutic options.

A global, randomized, phase 1b/2 trial is evaluating IO-108 in patients with metastatic and/or unresectable hepatocellular carcinoma.

The panelist discusses first-line options including atezolizumab plus bevacizumab, lenvatinib, and sorafenib. Second-line treatments include regorafenib, cabozantinib, and ramucirumab. Clinical trials should be prioritized when available.

The panelist discusses the case of a 60-year-old man diagnosed with unresectable hepatocellular carcinoma (HCC). The patient has a history of metabolic dysfunction-associated steatohepatitis managed with lifestyle changes and medication. Initially, there was no clinical or radiographic evidence of cirrhosis. The patient recently presented to his gastroenterologist complaining of abdominal pain in the upper right quadrant and fatigue.

Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.

The CheckMate 9DW study demonstrated the efficacy and manageable safety of first-line nivolumab plus ipilimumab in patients with unresectable hepatocellular carcinoma.

TACE with camrelizumab and rivoceranib significantly improves PFS in unresectable HCC, per phase 2 CARES-005 study results.

The FDA granted orphan drug designation to amezalpat in hepatocellular carcinoma based on phase 1b/2 data showing efficacy and safety with atezolizumab and bevacizumab in frontline treatment.

During a Case-Based Roundtable® event, Pierre Gholam, MD, discussed how post hoc and real-world analyses build upon the limited available trial data for treating patients with unresectable hepatocellular carcinoma with Child-Pugh B status.

The FDA approved a phase 3 trial to assess amezalpat with the current standard of care in unresectable or metastatic hepatocellular carcinoma.

The new drug application resubmission of rivoceranib/camrelizumab in the first line in unresectable or metastatic hepatocellular carcinoma is supported by the final survival analysis of CARES-310 trial.

A new drug application has been resubmitted to the FDA for the combination of camrelizumab and rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma, following a complete response letter in May 2024.

The HIMALAYA study showed that the combination of tremelimumab and durvalumab significantly improved overall survival in patients with hepatocellular carcinoma.

A combination of lenvatinib, pembrolizumab, and TACE significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma compared to dual placebo and TACE.

The application is supported by the phase 3 CheckMate -9DW study, and the FDA has set a target action date of April 21, 2025.

During a Case-Based Roundtable® event, Pierre Gholam moderated a discussion on how to proceed with a patient presenting with a LI-RADS 5 mass suspected of being hepatocellular carcinoma.

The FDA has given positive feedback on the planned phase 3 study for the combination of amezalpat, atezolizumab, and bevacizumab in the first-line treatment of unresectable or metastatic hepatocellular carcinoma.

A phase 1 trial is evaluating treatment with MT-303 in patients with hepatocellular carcinoma to determine its safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy.