Cancer Pipeline Reports Show 45+ CSCC, 70+ Liver Cancer, and Multiple HCC Therapies in Development

DelveInsight's pipeline reports depict robust clinical development spaces across multiple cancer indications, with 45+ active players advancing 45+ pipeline therapies for cutaneous squamous cell carcinoma treatment, 70+ companies developing 75+ pipeline drugs for liver cancer, and numerous companies working on hepatocellular carcinoma therapies across multiple stages from discovery through Phase III.

In October 2025, FDA approval of cemiplimab‑rwlc (Libtayo) as adjuvant therapy for adults with cutaneous squamous cell carcinoma at high risk of recurrence following surgery and radiation, based on the phase III C‑POST trial. In January 2025, positive phase III C‑POST trial data showed adjuvant cemiplimab significantly improved disease‑free survival versus placebo in high‑risk cSCC, with a 68% reduction in recurrence or death and very low locoregional and distant relapse rates.

In February 2026, the FDA granted Fast Track designation to irpagratinib for the treatment of previously treated advanced hepatocellular carcinoma characterized by FGF19 overexpression. The FDA awarded Fast Track status to irpagratinib (ABSK-011) for individuals with advanced HCC whose tumors overexpress fibroblast growth factor 19 (FGF19) and who have already been treated with immune checkpoint inhibitors and multi-targeted kinase inhibitors.

In April 2025, the FDA granted full approval to the combination of nivolumab and ipilimumab as a first-line treatment for adults with unresectable hepatocellular carcinoma. The approval is based on results from the Phase III CheckMate 9DW study, which showed that the dual immunotherapy regimen delivered a statistically significant and clinically meaningful overall survival benefit compared with physician-selected monotherapy using sorafenib (Nexavar) or lenvatinib (Lenvima).

In February 2025, the FDA granted fast track designation to RZ-001, an RNA substitution enzyme-based cancer gene therapy, for the treatment of patients with hepatocellular carcinoma. Additionally, RZ-001 has received investigational new drug approval for glioblastoma from both the FDA and South Korea's Ministry of Food and Drug Safety, and it has been approved for compassionate use under the FDA's expanded access program for this condition.

In January 2025, the US Food and Drug Administration granted Orphan Drug Designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma.

Incyte Corporation holds the most clinically advanced CSCC pipeline candidate, with its drug in Phase II clinical evaluation, reflecting the growing momentum behind JAK inhibitor-based dermatological treatments. Opzelura is a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib. It is the first and only topical JAK inhibitor approved in the United States for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Currently, Opzelura is in Phase II clinical trial evaluation for the treatment of Cutaneous Squamous Cell Carcinoma.

Shanghai Henlius Biotech's HLX07, an engineered anti-EGFR monoclonal antibody bio-better of cetuximab, is currently in Phase II clinical evaluation for CSCC, with patents secured across China, the United States, the European Union, Australia, and Japan. HLX07 is a bio-better independently developed by Henlius using its advanced antibody engineering platform. Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07, aiming to reduce immunogenicity and increase binding affinity. Pre-clinical studies demonstrated that HLX07 binds EGFR with comparable affinity and exhibits superior bioactivity relative to cetuximab.

Rakuten Medical's RM-1995, a first-in-class CD25-targeting antibody-dye conjugate employing photoimmunotherapy to deplete intratumoral regulatory T cells (Tregs), is currently in Phase I clinical development for CSCC.

On February 24, 2026, a phase 1B/2 open-label study was announced to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.

On February 20, 2026, a phase 3 study was initiated to evaluate the efficacy and safety of paltusotine in adults with carcinoid syndrome. The study includes a screening period of up to 11 weeks, a double-blinded randomized control period of 16 weeks, an open label extension period of 104 weeks, and a follow-up period of 4 weeks.

On February 18, 2026, a study was conducted to see if one session of high-dose contrast-enhanced MRI-guided SBRT (stereotactic body radiation therapy) is effective for colorectal cancer that has spread to the liver. The researchers will evaluate how well the study treatment can prevent the liver metastasis from growing and spreading.

Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5'- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR). Namodenoson's mechanism of action is mediated via deregulation of the NF-κB and Wnt signal transduction pathways, resulting in the apoptosis of tumor cells. Currently, the drug is in Phase III stage of its development for the treatment of advanced liver Cancer.

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications.

In November 2024, new pre-clinical data was presented on an antiGPC3 in vivo chimeric antigen receptor macrophage and monocyte (together, "CAR-M") therapy for the treatment of hepatocellular carcinoma, developed in collaboration with Moderna, Inc.

In October 2024, regulatory approval was received from the Israeli Ministry of Health in July 2024, followed by institutional review board clearance to begin patient enrollment in up to seven academic centers. The clinical trial will assess the safety and efficacy of NY-303, a GPC3-targeting NK Engager bispecific antibody, as a monotherapy for treating hepatocellular carcinoma in patients who have not responded to first-line immunotherapy.

Cutaneous squamous cell carcinoma is one of the most prevalent non-melanoma skin cancers, arising from keratinocytes within the epidermis; UV radiation-induced p53 mutations account for the majority of cases, underscoring an unmet need for targeted systemic and topical therapies. Each year in the United States, about 25,000 men and 11,000 women get liver cancer, and about 19,000 men and 9,000 women die from the disease. The percentage of Americans who get liver cancer rose for several decades, but is now declining.