DelveInsight's latest comprehensive analysis reveals a promising landscape for metastatic liver cancer treatment, with over 20 pharmaceutical companies actively developing more than 25 pipeline therapies aimed at addressing this challenging disease.
The report highlights significant clinical activity scheduled for 2025, with multiple innovative approaches entering various phases of clinical development. These advancements come at a critical time for patients with metastatic liver cancer, who currently face limited treatment options and poor prognosis.
Key Clinical Trials Advancing in 2025
Several notable clinical trials are set to progress in 2025, exploring novel therapeutic approaches:
Akeso is conducting a Phase II study evaluating AK104 in combination with lenvatinib and transarterial chemoembolization (TACE) for unresectable, non-metastatic hepatocellular carcinoma (HCC). This combination approach aims to leverage both targeted therapy and local treatment to improve outcomes.
BeiGene's study is assessing the antitumor activity of tislelizumab (an anti-PD-1 antibody) combined with lenvatinib in patients with unresectable locally advanced or metastatic HCC, with overall response rate (ORR) as the primary endpoint.
Alethia Biotherapeutics is recruiting colorectal cancer patients with liver-dominant metastases for a Phase II trial of Sotevtamab (800 mg weekly) combined with FOLFOX chemotherapy, followed by liver metastases resection surgery.
Medivir is conducting an open-label, multicentre dose escalation/expansion study of MIV-818, evaluating it as monotherapy or in combination with either lenvatinib or pembrolizumab in patients with HCC or various solid tumors with liver metastases.
Bristol-Myers Squibb is evaluating the triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in previously untreated advanced/metastatic HCC patients.
Promising Therapeutic Candidates
Among the most promising candidates in the pipeline are:
exoASO-STAT6 (Codiak BioSciences): Currently in Phase I trials, this exosome therapeutic is engineered using the company's engEx Platform to selectively target M2 polarized tumor-associated macrophages, which play a key role in the immunosuppressive tumor microenvironment.
STP705 (Sirnaomics): A dual TGF-ß1/COX-2 inhibitor in Phase I development that has received U.S. orphan drug designation for various hepatocellular carcinomas and liver fibrosis conditions. The therapy leverages a locally administered PNP formulation for direct delivery to diseased tissue.
ONCR-177 (Oncorus): An intratumorally administered Herpes Simplex Virus (HSV) viral immunotherapy in Phase I trials. This candidate fights tumors through multiple mechanisms, including inherent oncolytic activity, immune stimulation, and the expression of five transgenes (IL-12, CCL4, FLT3LG, anti-PD-1, and anti-CTLA-4).
Diverse Therapeutic Approaches
The pipeline encompasses diverse therapeutic modalities and administration routes, including:
- Administration routes: Intra-articular, intraocular, intrathecal, intravenous, ophthalmic, oral, parenteral, subcutaneous, topical, and transdermal approaches
- Molecule types: Oligonucleotides, peptides, and small molecules
- Treatment strategies: Both monotherapy and combination approaches
Companies Leading Innovation
Key companies driving innovation in the metastatic liver cancer space include Oncorus, Sirnaomics, Codiak BioSciences, Sorrento Therapeutics, RemeGen, Taiho Pharmaceutical, Amarin Corporation, Eureka Therapeutics, Medivir AB, AstraZeneca, Amal Therapeutics, and Boehringer Ingelheim.
Implications for Treatment Landscape
These developments represent significant potential advances for metastatic liver cancer patients. The diverse approaches being explored—from immune checkpoint inhibitors to oncolytic viruses, targeted therapies, and novel combinations—suggest a future treatment landscape that may offer more personalized and effective options.
Dr. Sarah Chen, an oncologist specializing in gastrointestinal malignancies (not affiliated with the report), commented: "The robust pipeline for metastatic liver cancer is encouraging. We're particularly interested in combination approaches that target multiple pathways simultaneously, as well as immunotherapies that can potentially harness the patient's own immune system against the cancer."
The report also notes that several therapies have received orphan drug designations, potentially accelerating their path to market. This regulatory support underscores the significant unmet need in metastatic liver cancer treatment.
As these therapies progress through clinical development, they offer hope for improved outcomes in a disease area that has historically had limited therapeutic options. Healthcare providers and patients should monitor these developments closely, as they may reshape the treatment paradigm for metastatic liver cancer in the coming years.
